Since the 1790s, vaccines have been around and proven as crucial life-saving tools. Yet, there was unfounded controversy over their value at the start of 2020, and new development programs were lagging.
Image credit: Pall Corporation
In the spring of 2020, that quickly changed as the COVID-19 pandemic took hold around the world. Vaccines became mainstream media and one of the hottest topics in industry practically overnight. This article will outline what it takes to produce great vaccines.
Regulating quality
All platform manufacturing processes are created to de-risk, simplify and accelerate the development and manufacture of drug substances, although there is no one-size-fits-all platform approach for vaccine production.
Despite the risk-adversity of this industry, in the past five to ten years, iterative improvements to platform processes have helped to grow rates of adoption. Though standardization remains in flux, advances such as continuous manufacturing technologies and single-use technology have permitted more ease of use and flexibility.
The COVID-19 vaccine development rush is acting as a catalyst to advance innovation leveraging from gene therapy-based therapies and standardization and putting the power of platform technologies on full display.
QbD methodology from the United States Food & Drug Administration provides valuable guidance on how to optimize a process using the right platform, although there is still progress required.
Guidance on the correct QbD methodology includes completing a risk assessment, mechanistic models, design of experiments (DoE) and data analysis; leveraging prior knowledge where feasible; and implementing process analytical technologies (PAT) to focus on establishing1:
- A quality target product profile (QTPP) which recognizes the critical quality attributes (CQAs) of the drug product
- Product design and understanding, including identification of critical material attributes (CMAs)
- Process design and understanding, including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs
- A control strategy that includes specifications for the drug substance(s), excipient(s) and drug product in addition to controls for each part of the manufacturing process
- Process capability and continual improvement
- State-of-the-art risk management strategies and orthogonal approach to viral safety (including when the product is a virus)
- An integrated method to ensure product safety through quality risk management (QRM)
Integration enables innovation
There is a myriad of final manufacturing environments available today, including hybrids, traditional facilities, stick-builds, modular concepts and prefabricated formats.
Manufacturers are focused on leveraging integrated end-to-end-process solutions which look beyond the core process unit operations and extend to supporting every operation, including fluid management and buffer preparation.
In order to achieve this, they require adequate performance characterization to get vaccine or drug candidates moving to the next stage in the development process.
This means that platform selections are made based on performance attributes and real-world advantages like scalability, ergonomic design, usability and economy. Optimizing money, time and quality are vital to meeting market demands and access to a wide variety of options and support in building the right platform is needed.
Building platforms for process success
Pall Biotech has focused support teams to complement enabling technologies and works with customers to define and build scalable platforms for the life of a process.
The Scientific and Laboratory Services (SLS) team gives ad hoc field-based customer and technical services or validation support, while The Accelerator℠ Process Development Services (PDS) team provides downstream, upstream and analytical support.
These teams are able to consult on the effect of choosing the best technology for each application. These may include utilizing a membrane-based purification to reduce empty viral vectors from full instead of ultracentrifugation or assessing single-use depth filtration over centrifugation for clarification of a monoclonal antibody.
In the same way, this consultancy extends upstream to more fundamental decisions, for example, choices between using adherent cell culture systems or single-use suspension for viral vector production, which scale easily, instead of traditional roller bottle and flatware selections that do not.
Decades of bioprocess engineering expertise are put into the Allegro™ STR single-use stirred tank bioreactor portfolio. Proven to supply scalable, consistent, suspension cell culture performance in both viral vectors and monoclonal antibodies.
The iCELLis® 500+ fixed-bed bioreactor is the market leader for supporting gene therapy drug commercialization for adherent cell culture.
Integrated with downstream technologies such as the Stax™mAx single-use clarification platform for depth filtration, which can eliminate the requirement for centrifugation or process additives, vaccine manufacturers can attain faster and more robust performance without compromising on product safety and quality.
The manufacturer has a solution for the life of their process as this platform scales directly with a range of formats and sizes that are suitable for large-scale clinical production through to bench-top testing.
Critical formulation and filling operations are supported by a wide variety of automated solutions and sterilizing grade filters to ensure manual interventions are minimized to heighten sterility assurance.
On demand innovation
The COVID-19 pandemic is proving what this industry can achieve under pressure.
The team at Pall Biotech is on-demand to support advanced medicine production, such as gene and cell therapies or vaccines, with end-to-end platforms and support for complete process solutions using extensive bioprocessing experience both in gene therapy and biologic therapeutic products.
About Pall Corporation
Pall Corporation is a global leader in high-tech filtration, separation and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry.
Pall Life Sciences provides cutting-edge solutions for customers who discover, develop and produce biotech drugs, vaccines, cell therapies and classic pharmaceuticals.
Our advanced medical technologies are often a patient’s last line of defense from dangerous pathogens. And our food and beverage products provide critical protection from contaminants during various manufacturing steps.
Pall Industrial serves customers in the microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation industries.
Our products play key roles in:
- Manufacturing innovative semiconductors and consumer electronics
- Filtration for commercial and military aerospace vehicles
- Maintaining reliability of essential industrial equipment
- Addressing mounting water quality, scarcity and demand issues
- Helping energy companies maximize production and develop commercially successful next generation fuels
Headquartered in Port Washington, New York, Pall has offices and plants throughout the world.
For more on how we enable a greener, safer future, visit Pall - Enabling A Greener, Safer Future.
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