Because of these changes, the use and adaptation of smart MedTech devices and IoMT connected wearable devices have increased from both the people as well as the healthcare providers. For instance, a group of hospitals from South England that serve around 500,000 people annually have started discharging their patients with wi-fi enabled armbands to track vitals such as respiratory rate, oxygen levels, pulse, blood pressure, and body temperature. (Source)

Capability Augmentation with AI in MedTech 

While remote monitoring and continuous monitoring are made possible for patients with IoMT and smart medical wearable devices, certain areas of healthcare need attention and where there are opportunities for better patient care. However, it is not possible to make certain opportunities accessible to patients affordably and conveniently when they are done manually.

For such areas of opportunities such as data accumulation from various sources, providing continuous preventive care and interventions, real-time access to information and others, instead of using a manual approach which is not even feasible in some of the use cases, Artificial Intelligence can play a vital role. 

With the help of AI-driven wearable, IoMT and MedTech devices; healthcare providers can generate better care opportunities that can reduce ER and re-admission visits as well as cost-effectively deliver treatment adherence.

To understand how AI can contribute to MedTech and IoMT development, below are certain use cases as to how AI can be employed for the IoMT solutions and their impact on diagnostics and treatment. 

Combining AI and IoMT solutions for Diagnostics and Treatment- Bringing ‘the Next’ in healthcare 

• Accurate diagnostics and data collection:

When a wearable is approved by a physician or a healthcare professional, they can define certain criteria or parameters of vitals that they wish to monitor and AI can help them not only in monitoring those personalized vitals for each patient, but it can also collect data from various sources and present a better and personalized health journey to the healthcare professionals and enable them to make informed decisions.

With the help of AI-driven wearable technologies, physicians can scan health data easily and can also get personalized alerts and reports for each patient helping them better diagnose patients with relevant, personalized, and remote vital health information. 

While continuous monitoring would not have been possible without wearable technology, the accumulation of accurate and personalized data would not have been seamlessly accessible without AI. Thus, with the help of AI in medical-grade smart and connected devices healthcare professionals can ensure accurate diagnostics and deliver personalized care with case-specific patient data accumulation from AI. 

• Lifestyle interventions and reminders:

Even when we talk about the general benefits of employing AI in healthcare, preventive care has been a major benefit of AI in healthcare. Similarly, when we talk about combining wearable technology with AI, it can help with lifestyle interventions and reminders to patients.

According to WHO, 60% of related factors to individual health and quality of life are correlated to lifestyle (source). This means that by making certain interventions and lifestyle changes in a person’s life as and when required, the person can avoid a lot of chronic diseases and their impact on their life. 

Since medical wearables are increasingly adopted by patients and they wear them every day, combining these devices with AI can be used to deliver lifestyle interventions and reminders! For instance, a patient who is suffering from high blood pressure not only needs medication, but also need to do certain exercises, reducing stress and performing meditation can help profoundly to keep things in check.

With the help of AI-driven wearable solutions, patients can get such alerts that are not just timed accurately based on physician’s advice, but these interventions and reminders for medication and certain lifestyle activities can also be based on vital signs shown by the patients.

• Better public health information with wearable AI-driven data representation: 

Along with clinical and physician-based applications of wearable devices, one major area where medical devices are increasingly used is Clinical Trials. Along with that, sensor-based data from medically approved devices can also be useful for Clinical Research Organizations! 

With the help of AI-driven wearable and IoMT devices, Clinical Trial officers and Clinical Researchers can use the data collected with medical devices and identify patterns, access data, and get personalized patient profile comparisons using AI! 

While medical devices and IoMT solutions help with collecting health vital information, AI can help with comparisons and better data representations or collecting relevant data with defined criteria of patient profile comparison. 

AI-driven Accurate Predictions 

One of the biggest applications of AI in combination with medical devices is to provide accurate predictions to patients as well as healthcare professionals. When devices are designed for specific use cases and they cover all the integral aspects that must be monitored, predictions can be facilitated with the help of AI!

While there are many different methods of providing such predictions, the benefit of employing AI for the job is that it can diagnose these parameters in real time and deliver accurate predictions with “net-zero marginal cost!” 

AI is for both- custom-tailored as well as comprehensive care 

As we can see when it comes to IoMT and AI, it can be used for both personalized care as well as a holistic approach that extends beyond clinical and physician care! While wearable technology breaks the boundaries of clinical walls and facilitates remote care, AI breaks the data silos and augments the medical data reach. All it takes is a medical challenge and a skilled medical device that is powered by AI!

Around one out of every three adults all over the world experience symptoms of insomnia, and nearly 10% of adults actually have insomnia disorder. This is a major health concern, given the prevailing lifestyle and work-life patterns.

This pretty much explains why people are looking for quick and effective solutions. This is precisely where the Cognitive Behavioral Therapy for Insomnia (CBT-I) techniques come to the rescue. Let’s shed some light on the same:

Unlike OTC medications that offer temporary relief, CBT-I delves deep into identifying and addressing the foundational causes of insomnia. Thereby, it offers a more holistic solution.

But how does this approach work?

Well, Cognitive Behavioral Therapy helps you change thoughts and behaviors that are causing or worsening sleep problems. It teaches techniques and habits like relaxation, breathing exercises, self-hypnosis, and biofeedback to control stress and improve changing sleep routines.

Exploring Peptides for Enhanced Healing

Research is actively being conducted to explore the potential of peptides, focusing specifically on Pentadecapeptide BPC-157, to boost the body’s healing processes. Healing here refers to Tendon and ligament, Gastrointestinal, and Wound healing.

In simple words, this peptide acts by promoting the repair and growth of tissues, which is crucial for healing. Nevertheless, the ongoing research is crucial in unveiling the various ways this peptide can be optimized to enhance its properties and possibly develop new therapeutic applications.

One thing is for sure: this would open up possibilities for more effective treatments in the future, with the potential to revolutionize healing and recovery processes in healthcare.

Progress in Cancer Detection Technologies

2023 is the year of A.I., and there’s no denying that. These remarkable advancements in Artificial Intelligence (AI) are beginning to yield breakthroughs, particularly in the area of breast cancer screening.

To be more specific, these developments are crucial as they are aiding in the identification of signs often overlooked by doctors. According to the early results, the new technology aids in finding cancer as well as, and sometimes even better than, human radiologists.

Beyond Artificial Intelligence, medical imaging, and diagnostic tool advancements are continuously evolving. Thereby contributing significantly to the early detection of cancer. Techniques such as 3D mammography and advanced MRI provide clearer, more detailed images. This allows for more accurate diagnoses and, consequently, earlier interventions.

Molecular diagnostics is another area witnessing rapid development, enabling the identification of unique genetic markers associated with various cancer types. These non-invasive tests detect circulating tumor DNA in the blood, providing insights into the presence and characteristics of cancer.

Path Forward with Pharmacogenetic Testing

Pharmacogenetic tests are ushering in a new era where the optimal drug is chosen and tailored to each patient’s unique genetic makeup. This eliminates the guesswork involved in prescribing medications.

It is worth noting that, at the moment, these tests are limited to a select number of drugs. However, they represent a significant stride in personalized medicine, especially in psychiatric treatments, including antidepressants, antipsychotics, and ADD treatments.

This groundbreaking approach already has evidence supporting its effectiveness in improving treatment outcomes. A notable meta-analysis released in the Pharmacogenetics Journal in October 2022 illustrated that patients with major depressive disorder experienced enhanced response and remission rates after 8 and 12 weeks of treatment when genotype-supported selections guided their treatment.

This emerging field holds immense promise to redefine treatment plans and medication selections, making them more patient-centric, efficient, and, importantly, more effective.

To Sum It All Up

Reviewing the exploration of this year’s medical breakthroughs, it’s inspiring to see the leaps modern healthcare is making. From the utilization of enhanced technologies for early cancer detection to the adoption of personalized treatment plans through pharmacogenetic testing, we are witnessing a transformative phase in healthcare.

In fact, these innovations are not just reshaping the healthcare landscape; they are elevating it to new heights, making health and well-being more attainable for all. This leaves us optimistic about the future of healthcare- ensuring an enhanced quality of life and care for everyone.

FAQs

What is a significant development in treating insomnia?

A big development is the use of Cognitive Behavioral Therapy for Insomnia (CBT-I). It helps people change thoughts and behaviors causing sleep problems and teaches techniques to control stress and improve sleep.

How are peptides contributing to medical advancements?

Peptides, like Pentadecapeptide BPC-157, are being researched for their ability to promote healing by reducing inflammation and accelerating wound healing.

What is the importance of pharmacogenetic testing?

It’s important as it helps in personalizing medicine, allowing for more effective and efficient treatment, especially in psychiatry.

What are the future prospects for peptide research in medical science?

The research on peptides like BPC-157 is promising and continues to explore its potentials. The future might see more advanced applications of peptides in healing and possibly in developing new therapeutic applications for various health conditions.

Are there any developments in the treatment of ADD?

Yes, pharmacogenetic testing is being applied to ADD treatments to help select the most suitable medications based on individual genetic make-up.

A recent study in 2022 has revealed that a total sum of 110,000 claims are denied due to prior authorization in healthcare facilities. These denials can be avoided if the billing process is carried out by a reliable Healthcare Revenue Cycle Management or medical billing  company. In this guide, We will be elaborating the entire billing process in detail. By the end of this journey, you will be able to understand the process of the medical billing.

What is the Medical Billing Process?

The medical billing process, also known as the billing cycle, starts with the registration of a patient and ends with reimbursement received by the provider. There are three key players: the patient, the provider, and the insurance company. The whole process revolves around these participants. Every step should be completed correctly so that the provider can receive payment on time. The process includes:

•  Check whether the patient is insured or not
• Correct coding for a specific diagnosis
• Claims submitted to the insurance company for reimbursement

Step-by-Step Guide to Medical Billing Process

Dealing with medical bills can be frustrating. It is time-consuming and stressful for medical billing companies. Following are the medical billing steps that you need to understand to speed up billing activities.

Step 1 Registration of Patients Information

The first step in the medical billing process is the registration of the patient’s data when he calls to make an appointment. This can be done in two different ways: manually and electronically.

The front desk staff needs to take the following information:

• Name
• Home Address
• Phone number
• Date of Birth
• Medical History
• Insurance Provider Name

The reasons for collecting this information are obvious. It helps to check the eligibility of the patient for the specific insurance program. If the data is accurate and precise, there are better chances that the insurance company will approve the claims.

Step 2  Verification of Insurance Coverage

The second step in the medical billing process is to check the insurance coverage of a patient. This step is quite simple and can be done by two different methods:

1. Direct call to the Insurance Company
2. Check Online

Insurance companies are just a call away. You can call to check the patient’s insurance card against the Medicare card. If the information, such as name, address, and date of birth, is not the same, it can be a cause of claim denial. You can also check the eligibility of patients through the online website. For this,  you only need internet connectivity.

Verification Checklist

• The start and end dates of a policy
• Copay specifications
• Coverage limitations
• Data regarding patient’s deductibles
• Documentation requirements

Step 3 Making Superbills

After the patient leaves the facility, the next step is to compile all the information on one document. An in-depth invoice summarizing the services given to patients is what we call superbills. It consists of the patient’s demographics, insurance, and medical information.

If a person is a regular client, he must update or verify the information already present on his record. The provider also needs to ask for official identification, such as a license or passport.

Superbills compiles the information, such as:

• Patient’s demographics
• Patient’s medical history
• Procedures and services
• About the provider and his practice’s policies
• Procedural coding

Step 4 Claim Generation and Submission

Biller uses the superbills to generate medical claims, which are then submitted to the insurance company. Be careful while generating the claims, as minor errors in coding and formatting can result in denials or rejections.

Claims must contain information such as procedural codes (CPT or HCPCS codes). They should strictly follow the Health Insurance Portability and Accountability Act (HIPAA).  Claims can be submitted directly or through a clearing house. Clearing houses act as a third party company which helps the insurance companies and healthcare providers to communicate.

Step 5 Monitoring of Claim Adjudication

The process by which payers decide whether or not a medical claim is valid and how much reimbursement will be given to the provider is called adjudication. The claims can be accepted, denied, or rejected at this stage.

If Accepted:

It is an ideal situation. If a claim is accepted, it will be processed further. The amount the insurance company will pay depends on the specific insurance plans.

If Denied:

Denied claims are those that are filed properly but do not fulfill the criteria for payment. There can be a reason that a biller has claimed a service that is not covered by that insurance company.

If Rejected:

Rejected claims are those that are not properly filed. There is some sort of error or mistake in the claim. Most of the rejected claims are never resubmitted. Thus, a huge amount of revenue is lost.

Step 6 Patient Statement

When the insurance company pays their part of the reimbursement, the remaining balance is transferred to the patient as a separate statement. If everything goes well, the patient will pay you for your time and efforts. The patient statement includes:

• How much the patient has paid
• How much the insurance company paid
• How much the patient still has to pay.

Step 7 Follow Up

Follow-up is the last and most important step in the billing process. You need to stay in touch until you get paid. Once the patient has received the payment statement,the biller should do anything possible to prevent any issues and facilitate the payment being received by the patient.

Conclusion

In conclusion, this journey has uncovered the secrets to a successful medical billing process. Through this guide, we have come to understand that the billing process is not just paperwork but an essential component which ensures that providers are given appropriate compensation for their services.

Partner with Medheave

If your billing process is not properly managed, this can lead to delays in payment and impact cash flow and revenue. Find a reliable partner who can handle all your billing and coding processes. Medheave’s highly qualified and trustworthy team can manage all your medical billing and coding processes, allowing you to focus on your patient’s treatment.

Have you ever wondered how laboratories keep their data accurate, their workflows efficient, and their compliance with regulatory standards impeccable? The answer lies in a game-changing technology: Laboratory Information Management System, or LIMS System. The global LIMS market is set for a remarkable 6.74% annual growth rate from 2023 to 2030. As a result, it’s time we understand how LIMS is transforming not only pathology and diagnostic labs but also labs across different industries.

Imagine this: A Pathology Lab Management Software recognized as the ‘best-in-class’ revolutionizes pathology labs by amplifying data accuracy and reliability while propelling efficiency and productivity to new heights. LIMS’s significance extends beyond the confines of a lab; it’s a catalyst for collaboration and data sharing, fostering teamwork among departments, organizations, and even nations. 

Use of LIMS has revolutionized personalized medicine, empowering healthcare professionals with insights from individual patient data. What’s more, it’s instrumental in delivering high-quality diagnostic testing, influencing patient care, public health planning, and policy decisions. The impact is transformative and far-reaching.

The growth in the LIMS market and its domino effect on the healthcare industry is evident. To comprehend the LIMS impact on diagnostic labs, let’s focus on the past and future trends in the LIMS global market. This way, we can have a readily available study to make better decisions about implementing LIMS. 

Past Trends in the LIMS Market

Growing Adoption

Over the past decade, there has been a significant surge in the adoption of Laboratory Information Management Systems (LIMS) across various industries. There are multiple reasons that have led to the growth of LIMS. One of these factors includes the growing need for Pathology Lab Software to ensure adherence to strict regulatory standards. Another factor is the rising necessity for IT solutions, and finally, there is a growing emphasis on enhancing laboratory efficiency. Some of the key sectors that have enthusiastically embraced LIMS include:

1. Pharmaceuticals: LIMS finds extensive application in the pharmaceutical industry for efficiently managing and organizing data about drug development, clinical trials, and quality control processes.
2. Biotechnology: In biotechnology, LIMS handles data related to gene sequencing, protein analysis, and various other research and development procedures.
3. Healthcare: LIMS plays a crucial role in healthcare by facilitating the management of patient data, encompassing medical records, test results, and other diagnostic information. It also plays a crucial role in pathology labs as the best Pathology Software, streamlining diagnostic processes and ensuring accurate results.
4. Environmental Sciences: Within environmental sciences, LIMS is instrumental in the management of data associated with water quality, air quality, and various environmental monitoring processes.
5. Food and Beverage: The food and beverage industry utilizes LIMS to effectively manage data concerning quality control, safety testing, and adherence to regulatory compliance standards.

The LIMS market is set to grow, reaching USD 4.37 billion by 2030. Research demands, compliance needs, personalized medicine, and data analytics will drive this expansion. There are different types of LIMS, such as on-premise, web-based, and cloud-based. Most of the SaaS is now cloud-based, and a similar trend is also visible in the LIMS market; let’s see how.

Shift to Cloud-based Solutions

Organizations are increasingly transitioning to cloud-based solutions due to the array of benefits they offer. Cloud-based LIMS provides scalability, allowing businesses to easily adapt to changing needs while maintaining reliability and up-to-date systems. Moreover, flexible pricing structures reduce upfront costs and eliminating expensive IT infrastructure and maintenance expenses leads to lower operational costs. The advantages of opting for cloud-based LIMS solutions are manifold. 

1. On-the-Fly Scalability & Reliability: Cloud-based LIMS offer scalable features, ensuring system agility and reliability.
2. Flexible Pricing Models: Cloud LIMS offers flexible pricing and scalability, reducing initial costs for small and mid-sized labs.
3. Reduced Operational Expenditures: It lowers costs by eliminating IT infrastructure and maintenance expenses, freeing up resources for core business.
4. Heightened Data Security: Data security features include encryption, access controls, and audit trails to safeguard against unauthorized access and misuse.
5. Minimal Installation and Maintenance Costs: Cloud-based LIMS solutions offer low installation and maintenance costs. 

Enhanced security, improved collaboration, and accessibility from anywhere are some of the best features. With easy installation and maintenance, it optimizes efficiency and productivity for modern labs and organizations. The shift to cloud-based solutions also paved the way for integrating several other technologies. Let’s see what has been the past trend. 

Integration with Advanced Technologies

In recent years, the Laboratory Information Management Systems (LIMS) landscape, including Pathology LIMS System, has undergone a significant transformation. This evolution has been driven by the integration of advanced technologies such as AI and IoT. These innovative additions have ushered in automation and powerful data analysis capabilities, fundamentally reshaping the industry.

1. Predictive Analytics: AI-driven LIMS can predict workflow issues and suggest solutions, boosting laboratory efficiency.
2. Machine Learning Algorithms: LIMS systems use machine learning to improve accuracy over time, aiding informed decision-making.
3. Natural Language Processing (NLP): NLP enables better communication between staff and LIMS systems.
4. Automated Data Analysis: AI automates data analysis, helping labs derive meaningful insights.
5. Smart Data Visualization: AI-enhanced LIMS provides intuitive data visualization, aiding decision-making.

This convergence of AI and IoT technologies is revolutionizing laboratories, enhancing efficiency, productivity, and data management. The trend is set to continue with ongoing advancements by LIMS providers using LIMS integration. Now that we have read the past trends let’s analyze the future in the LIMS market. 

Future Projections in the LIMS Market

As we enter the future, the LIMS landscape evolves in sync with technology trends. Cloud-based solutions are gaining traction, offering scalability, accessibility, and cost-efficiency like never before. The fusion of LIMS with cutting-edge technologies like AI, IoT, and data analytics promises to unlock deeper insights from vast datasets, revolutionizing laboratory operations. 

Continued Growth

The LIMS market is poised for continued expansion, projected to reach USD 3.3 billion by 2028 and USD 4.37 billion by 2030, with a 6.74% annual growth rate from 2023 to 2030. Also, this growth is driven by increased research demands, cloud adoption, technological advancements, efficiency focus, and rising R&D expenditure.

Personalized Medicine and Customization

LIMS supports personalized medicine through customization, allowing labs to tailor workflows to specific industry needs. For instance, Company B partnered with a leading pharmaceutical firm to create a customized LIMS solution emphasizing data management and analysis.

Data Analytics and AI Insights

Data analytics and AI are reshaping LIMS, enabling labs to extract meaningful insights from large datasets. AI-powered LIMS predicts issues, enhancing efficiency and productivity. Labs can make informed decisions and streamline operations.

Interoperability and Integration

Interoperability is vital in LIMS, enabling seamless integration with lab instruments and software. In fact, this improves workflows, reduces errors, and enhances data management. LIMS can integrate with electronic lab notebooks (ELNs) to foster better collaboration.

Cloud Adoption and Mobility

Cloud-based LIMS adoption is rising due to scalability and cost-effectiveness. Mobile LIMS apps offer flexibility and accessibility, empowering staff to access data and workflows anywhere. Cloud solutions provide agility with instant scalability.

Interoperability and seamless integration with other laboratory instruments and software systems are taking center stage, paving the way for even more efficient workflows. The services segment is also set to drive market growth, with implementation, integration, maintenance, validation, and support playing pivotal roles.

To Sum it All Up

The journey of LIMS, including Pathology Management Software, has only just begun, and the future appears incredibly promising. Projections indicate that by 2030, the LIMS market is expected to reach a substantial value of USD 4.37 billion. LIMS continues to serve as a driving force in the ever-evolving landscape of laboratory operations. The unwavering commitment to precision, compliance, and innovation propels the ongoing LIMS revolution, ensuring that laboratories remain at the forefront of scientific discovery and technological advancement. In essence, the LIMS revolution plays a crucial role in shaping the future of laboratory operations and healthcare.

Biopharmaceuticals refer to medicinal / therapeutic products that are either manufactured using living organisms or semi-synthesized from biological sources. These are essentially complex biological macromolecules, having high molecular weights, or cell-based products, which are not directly extracted from native biological sources, rather are produced using biotechnology tools and methods. The following figure provides an illustrative summary of the various types of biopharmaceuticals.

Since biopharmaceuticals are produced using living organisms, they require various prokaryotic and eukaryotic systems, such as bacteria, yeasts, insect cells and mammalian cells, for their manufacturing.

Further, considering the fact that biopharmaceuticals are essentially structural analogs of various biomolecules found in the human body, they are highly specific and have fewer side effects, as compared to conventional pharmacological molecules. These therapies are also deemed to possess the potential to target and eradicate the cause of a disease at the genetic level. The Biopharmaceutical Contract Manufacturing Market is anticipated to grow at a CAGR of around 9.6%, till 2035, according to Roots Analysis.

Expression Systems for Biopharmaceuticals

As mentioned earlier, the processes associated with the manufacturing of biopharmaceuticals are complex and require highly sterile and aseptic conditions. This can be attributed to the fact that the production of biopharmaceuticals requires living expression systems. Usually, the desired gene, such as human insulin gene, when inserted into the plasmid of the host cell uses transcriptional and translational machinery of the host to express itself. It is worth mentioning that in vitro gene expression  requires a suitable host for the production of a specific gene product. Presently, several expression systems are available for manufacturing of biologics; these include (in alphabetic order) insect, mammalian, microbial and plant expression systems. It is also important to note that the use of different systems is associated with their own set of culturing requirements, advantages, and drawbacks.

The figure below provides an overview of the various expression systems used for the production of biopharmaceuticals.

Mammalian versus Microbial Expression Systems

The table presents the differences between mammalian and microbial expression systems.

Source: Roots Analysis

Manufacturing Process of Biopharmaceuticals

The production process of biologics can be categorized into two major stages, namely upstream and downstream processing. Upstream processing includes the production and maintenance of the working microbial expression systems, whereas downstream processing comprises of the various chemical and physical separation steps required to isolate and purify the product from the culture mixture.

The following figure highlights the various stages of the manufacturing process of a biopharmaceutical product.

Upstream Processing

Upstream processing refers to the entire process of product development, beginning from isolation of the working cell bank, incubation under appropriate conditions, and expansion of the cell culture for the synthesis of the desired biopharmaceutical product. It is worth mentioning that the upstream process chosen for a particular biologic is greatly dependent on the various characteristics of the product, such as selection of host cell lines, culture media and the appropriate bioreactor system used. Steps involved in upstream processing of biopharmaceuticals are formulation of the fermentation media, media sterilization and inoculum development.

Fermentation

Fermentation is the final stage of the manufacturing process and involves the synthesis of the desired product within the microbial expression systems. Fermentation processes are typically of two types (based on oxygen requirements), namely aerobic (in the presence of oxygen) and anaerobic (in the absence of oxygen). The fermentation process is usually modified to suit the oxygen requirements of the microorganisms used. Fermentation processes can also be categorized into batch, continuous / perfusion and fed-batch operations (based on the strategy used to feed the culture and culture medium into the fermenter). During batch operations, the culture medium and seed culture is added to the fermenter at the beginning of the process, after which the system is closed and only oxygen or pH adjusting agents are added. Alternatively, in a continuous system, fresh medium is added in an uninterrupted manner throughout the operating time of the reactor. Further, spent media (containing microorganisms and products) is removed from the system at the same rate at which fresh medium (containing inoculum) is added. A fed-batch system is a combination of the aforementioned processes. In this method, fresh medium (containing inoculum) is added at regular intervals, however, harvesting takes place towards the end of the operation.

Downstream Processing

Post harvesting, additional steps are required to isolate microorganisms and remove impurities, such as contaminating cell proteins, nucleic acids, endotoxins and residual processing reagents, via centrifugation, filtration and chromatography. These techniques collectively form the basis for downstream processing and are usually performed on large volumes of complex biological mixtures. These operations are intended to extract, concentrate and purify the resultant product(s). During this process, components of fermentation mixture are separated based on various parameters, such as molecular size, electric charge, solubility and binding affinities. Steps involved in downstream processing are centrifugation, filtration, chromatography and fill / finish.

Advances in the field of human genetics have enabled the identification of various Mendelian disorders. Additionally, the insights generated from the Human Genome Project have led to a better understanding of genes and their role in disease initiation and propagation, thereby, accelerating drug development research, using DNA as a therapeutic molecule. However, this field is still niche and gradually evolving in the wake of ongoing technological advancements, such as discovery of appropriate vectors, better understanding of human immunology, and development of practical approaches to select clinical targets. Early initiatives in this domain reported that mammalian viruses are an efficient tool for gene delivery, which also have the potential to be used (directly or indirectly) for the treatment of several genetic disorders.

Despite certain setbacks, which were reported in other early studies involving retroviral vectors, there were two noteworthy trials that demonstrated the successful implementation of viral vector-mediated therapeutics. These studies were conducted in patients suffering from X-linked severe combined immunodeficiency (X-SCID) (2000) and ADA-SCID (2002). It is worth mentioning that, in both trials, treated patients reported successful long-term reconstitution of immune functions in the absence of enzyme replacement therapy. Although there were certain genotoxicity-related adverse events reported in the X-SCID trial, the clinical outcomes observed in both trials markedly outperformed the standard of care therapy used. This offered the necessary evidence to support the potential of gene therapies, establishing the foundation for future improvements. It is also worth mentioning that these studies highlighted the need for gene delivery vehicles that are both safe and efficient. Viral vector manufacturing market is anticipated to grow at a CAGR of around 14%, till 2035, according to Roots Analysis.

Types of Viral Vectors

It is a well-established fact that viruses are extremely efficient in delivering genetic material into a specific target cell, whilst managing to evade the host’s immune system by using the host’s cellular machinery to synthesize various structural and non-structural proteins, which later assemble into functional viruses capable of repeating the process in other target cells. These properties make them highly attractive as gene delivery vectors. Using viruses as vectors involves the manipulation of viral genome; essentially all virulence genes are removed (to prevent viral infection) and replaced with a functional copy of a therapeutic gene(s), along with all the necessary regulatory sequences that control its expression. These modified viruses are able to carry specific target cells with high efficiency. As indicated earlier, such a method of gene delivery is called transduction; likewise, a cell modified by a virus / viral vector is said to have been transduced.

1. Adeno-associated Viral Vectors

Adeno-associated virus (AAV) is a small virus of the Parvoviridae family that has a single stranded DNA genome. It is capable of infecting a broad range of host cells, including both dividing and non-dividing cells. It is a non-pathogenic virus that does not generate an immune response in most patients.

The AAV genome comprises of inverted terminal repeats (ITRs) at both ends of the DNA strand and two open reading frames (ORFs), namely rep and cap. Each ITR sequence consists of 145 bases that have the ability to form a hairpin structure. These sequences are required for the primase-independent synthesis of a second DNA strand and the integration of the viral DNA into the host cell genome. The rep genes encode proteins that are required for the AAV life cycle and site-specific integration of the viral genome. Whereas, cap genes encode the capsid proteins, namely VP1, VP2 and VP3.

2. Adenoviral Vectors

Adenoviruses are members of the Adenoviridae family that typically have a double stranded DNA genome. The size of an adenoviral genome is generally around 36 kb, however, such viruses can accommodate cDNA sequences of up to 7.5 kb. When an adenovirus infects a host cell, its genetic material (DNA) is inserted into the host cell, and not into the host’s genome. Instead, it is left free in the nucleus in the form of an extrachromosomal gene segment, which is also known as an episome. The information in this episomal DNA molecule is transcribed and translated in a manner similar to that of any other gene, however, episomes are not passed on to daughter cells post replication.

3. Lentiviral Vectors

Lentiviruses are also RNA viruses that belong to the Retroviridae family. Similar to retroviruses, they are also capable of stably inserting genetic material into the genome of a host cell. However, unlike retroviruses, these vectors can infect non-dividing cells as well. The only cells that lentiviruses cannot gain access to are quiescent cells (those in the G₀ state). This is primarily because cells in the G₀ phase inherently block the reverse transcription step. Examples of lentiviruses include:

• Human immunodeficiency virus (HIV)
• Simian immunodeficiency virus (SIV)
• Feline immunodeficiency virus (FIV)
• Equine infectious anemia virus (EIAV)

4. Retroviral Vectors

Retroviral vectors are RNA viruses that belong to Retroviridae family. Within the host cell, these viruses synthesize double-stranded DNA molecules using RNA as a template; this process is facilitated by an enzyme, known as reverse transcriptase. The newly synthesized DNA can then be integrated into the chromosome of the host cell in a process that is carried out by another enzyme, known as integrase. Stable integration of the DNA synthesized from viral genome serves to modify the host cell, causing it to synthesize viral proteins. It is also worth mentioning that when the modified host cell divides, daughter cells retain copies of the viral genes and continue producing viral proteins.

5. Other Viral Vectors

Other viral vectors are classified under the following categories:

• Alphavirus: Alphaviruses belong to the Togaviridae family of viruses that are capable of infecting both vertebrates and invertebrates. Its genome is a single stranded RNA molecule, which is typically 11 to 12 kb, having a 5’ cap and 3’ poly-A tail. Additionally, the genome contains two ORFs that code for non-structural and structural components. In alphaviruses, the expression of viral proteins and the replication of the viral genome takes place in the cytoplasm of the host cell. It is also worth mentioning that certain retroviral and lentiviral vectors are usually pseudo typed using alphavirus envelope proteins, which facilitate the recognition and infection of a wide range of potential host cells.
• Foamy Virus: Foamy viruses, also known as spumaretro viruses, are known to impart a characteristic foamy appearance to the cytoplasm of the cells they infect, thereby leading to the development of multinuclear syncytia. They are found in several mammals, including cats, cows and captive nonhuman primates, excluding humans. The safety profiles of foamy viruses for clinical purposes has made it a preferred choice as compared to other vectors, such as γ-retroviral vectors. In terms of being used as a gene transfer tool, they offer several unique advantages over other integrating viral vectors, such as gamma-retroviruses and lentiviruses. These include a large packaging capacity (up to 12 kb), broad host and cell-type tropism, and safer integration profile with lower risk of insertional mutagenesis. These vectors can also be used to efficiently transduce quiescent cells; since its genome remains stable (in the form of cDNA) in growth-arrested cells / quiescent cells, it can be integrated into the host genome once the cell exits the G₀
• Herpes Simplex Virus: The herpes simplex virus (HSV) is a double-stranded DNA virus that belongs to the Herpesviridae It is a neurotropic virus that is known to infect humans, which makes it a likely candidate for being used for the transfer of genes to the nervous system. The relatively large genome of the virus enables the insertion of more than one therapeutic gene into a single virion. It is therefore possible to use HSV vectors for the treatment of disorders caused by more than one defective gene. It is worth mentioning that the HSV is able to infect a wide range of cells, including muscle cells, liver cells, pancreatic cells, neurons and lung cells. Typically, these vectors are designed to encode the HSV thymidine kinase enzyme, which makes the virus susceptible to acyclovir mediated inhibition. Acyclovir is a nucleoside analogue that is used to treat HSV infections and in this case, is administered along with the oncolytic virus therapy.
• Sendai Virus: Sendai virus is a non-segmented negative strand RNA virus, which belongs to the Paramyxoviridae It was discovered in 1953 in Japan and was primarily considered for the development of a xenotropic live-attenuated vaccine, owing to its antigenic similarity to the human parainfluenza virus type 1. The virus possesses certain unique characteristics, including a powerful capacity for gene expression, low pathogenicity and broad host range, which makes it a suitable vector candidate for the transfection of various animal cells. Despite the aforementioned benefits, vectors based on this virus are associated with inefficient chromosomal integration (of transgenes). These vectors have been used as a research tool in various life sciences domains, however, its utility as a recombinant viral vector has been identified recently. Owing to its ability to induce mucosal immunity, the vector has been significantly exploited as a vaccine platform. It has also been studied for cancer gene therapy at preclinical stage.
• Simian Virus: Simian virus 40 (SV40) belongs to the Polyomaviridae Typically, these viruses have a circular, double-stranded DNA genome which is 5.2 kb in length. Certain genes that are transcribed at an early phase in the viral life cycle (early genes) include the large T antigen (Tag) and the small tag. Similarly, genes transcribed later during the life cycle of the virus (late genes) include the regulatory protein, agnoprotein and three structural proteins (namely VP1, VP2 and VP3). The Tag gene confers immunogenic properties to the recombinant SV40 viral vector; hence, it is deleted while developing SV40 vectors. The deletion of all the structural proteins, except the major capsid protein VP1, serves to reduce the overall size of the viral genome. The final vector genome is typically made up of the origin of replication and the encapsidation sequence, offering enough space for the incorporation of a transgene.
• Vaccinia Virus: The Vaccinia virus belongs to the Poxviridae family; it is comprised of a linear, double-stranded DNA genome, which is approximately 190 kb in length and codes for close to 250 genes. It has the capability to replicate its genetic material in the cytoplasm of the host. Based on the composition of its outer membranes, the vaccinia virus can be divided into four types, which include intracellular mature virion, intracellular enveloped virion, cell associated enveloped virion and extracellular enveloped virion. This virus is popular owing to its use in the development of the vaccine that enabled the eradication of smallpox. With a packaging capacity of up to 25 kb of foreign DNA, the vaccinia virus can be efficiently used for the delivery of large gene sequences.

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