INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Biosafety In Gene Therapy: Applying The Latest Regulatory Guidance For RCL Testing

  The use of lentivirus vectors to produce groundbreaking gene therapies is on the rise. Ensuring the biosafety and quality of these vectors is achieved through a multi-tiered testing approach. For lentivirus-based therapies, generation of replication competent particles is a potential risk. While improvements in design and manufacturing have decreased the probability of producing replication competent viruses, regulatory agencies provide guidelines to test for their presence at multiple stages in production.

• Evaluating Quality Systems With Your Manufacturing Partners

  The landscape surrounding regulatory guidance is constantly changing as the cell and gene therapy industry continues to evolve. Ken Bonnell, Senior Vice President of Quality and Regulatory Affairs, shares insight on what to look for and what is important when evaluating quality systems with manufacturing partners.

• Analytical Considerations For Biopharmaceuticals During Commercialization

  As a project approaches its process performance qualification phase, it is crucial to understand the expectations of regulatory agencies and identify the most efficient ways to validate the analytical methods.

• Clinical Readiness – Practical And Innovative Solutions For AAV Development And Manufacturing

  What are the current challenges and future promises of adeno-associated virus (AAV), lentivirus, and lipid nanoparticles in gene therapies? George Buchman, Ph.D., Vice President of Preclinical & Process Development at Catalent Gene Therapy, discusses specific case studies for neuromuscular degenerative indications, AAV technology and manufacturing, strategies for navigating the current regulatory environments in the U.S. and Europe.

• No Place Like Home: How To Make Decentralized Clinical Trials A Win For Patients, Sponsors & Investigators

  Nearly three out of four biopharmaceutical firms modified traditional protocols to adopt a form of decentralized studies – also known as virtual or siteless trials – in an effort to keep drug development programs on course during COVID-19. This eBook focuses on the integral role Direct-to-Patient Services play in the execution of decentralized trials and how sponsors can maximize these benefits to improve drug development.

• Beyond mRNA Vaccines – Emerging Applications For Lipid Nanoparticle Delivery Technologies

  The potential of lipid nanoparticle-based drug delivery technologies to enable a new generation of medicines was made clear in 2020 when the first two mRNA vaccines for COVID-19 were rapidly developed and authorized for emergency use. What other applications are now being explored for such delivery technologies? Dr. Jay Natarajan, Director of R&D, competence center for LNP technology, answers questions in this interview.

• Regulatory Consideration For Biotech Startups

  With the move into clinical studies, emerging biopharmas turn the page to an exciting new chapter in their stories. This is a time of dramatic change, due in no small part to a rapid ramp-up in face time with regulatory agencies and the expectation of data transparency that ensues. Fortunately, the whirlwind of simultaneous activity that biopharma leaders might be seeing for the first time isn’t entirely uncharted territory. We caught up with several startup veterans for insight and inspiration on navigating clinical-stage regulatory considerations.

• Roadmap To Market For Cell And Gene Therapies Webinar

  Nothing is standard about the study design, study conduct or the regulatory process in cell and gene therapy trials. Every cell and gene therapy is different due to the specific characteristics of each product, with a complicated regulatory approval process and unique therapeutic challenges. In this webinar, participants will learn an end-to-end approach to bringing a cell and gene therapy to market.

• Regulatory Operations

  Provide seamless collaboration on documents and submissions throughout a spectrum of services: medical writing, quality control review, document- and submission-level publishing, and health authority submission management.

• Aldevron Offers Virtual Facility Audits

  Because travel restrictions due to the ongoing global coronavirus pandemic have made in-person audits extremely difficult or impossible, our clients now have the option to complete facility audits virtually. Now, our clients can complete audits from the security of their home offices, from anywhere in the world.