INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

• Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions

  Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of adeno-associated virus (AAV) delivered gene therapy and messenger RNA (mRNA) vaccines and therapeutics. Plasmid DNA sequences often present challenges with certain notorious regions, such as inverted terminal repeats (ITRs) in constructs containing transgene sequences and long poly-A tail contents in mRNA template plasmids.

• Reliability And The Future Of Cell & Gene Therapies

  This interview focuses on how cell and gene companies are focusing on reliability and predictability to further advance these innovative therapies.

• Developing Advanced Therapies: Considerations For Internal Versus External Manufacturing

  Due to their complexity and cost, developers of cell and gene therapies face unique manufacturing hurdles. Determining the right approach to manufacturing is crucial when bringing these advanced therapeutics from clinical to commercialization. This paper provides a distinct perspective on how to approach manufacturing and other roadblocks at every stage of development.

• Closing Ancillary Processes: The New Bottleneck In Cell and Gene Therapy

  One of the continued challenges for scalable commercial manufacturing of cell therapies is closing and automating the entire manufacturing process. Many core manufacturing processes may be closed, but peripheral systems e.g. media formulation, viral vector packaging remain open – introducing opportunities for failures. Invetech’s approach enables manufacturers to close and integrate both core and peripheral processes.

• Drug Repurposing Trends And Strategic Approaches For Shortening Timelines

  As the complexity of drug development increases, so does the industry’s focus on strategies and solutions that can help bring advanced products to market as quickly as possible.

• Jumpstart Cell & Gene Therapy Commercialization With SUT Learning

  Single use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits. 

• Addressing The Talent Shortage For CDMOs

  Industry expert Mayo Pujols, CEO of Andelyn Biosciences, offers his perspectives on addressing the workforce challenges in the clinical manufacturing field.

• Best Practices For CDMO Evaluation, Selection, And Management

  When executed properly, outsourcing manufacturing scaleup to a CDMO can be an expeditious way to further mobilize the science and drug products. To provide a smooth transition from the lab to CDMO, there are important factors you must first understand and steps to take prior to searching for and engaging with an external partner. If this process is not executed properly, there is a risk of wasting valuable time, resources, and the potential to not have the requirements for success.

• COVID-19 Pandemic Has Exposed The Risks Of Reliance On Foreign Markets For Critical Drug Components

  The pandemic has exposed the risks of outsourcing the manufacturing and production of critical drug materials to foreign markets. Other challenges brought by COVID-19 has made it difficult to conduct clinical trials. Companies that provide clinical development have acknowledged their roadblocks to safely conducting trials. In general, our overburdened healthcare system and social distancing policies are creating a challenging landscape for the life science industry, and over-reliance on foreign markets are now exasperated in an already difficult environment. Actively working to scale-up and scale-out manufacturing during this critical period is crucial.

• Achieving Business Continuity In Pharma During COVID-19 Restrictions

  To ensure business continuity during COVID-19 restrictions, we developed a virtual factory acceptance testing solution that allowed SaudiVax to advance their manufacturing plan.