FEATURED ARTICLES

• Reducing Risk For Commercial Manufacturing Of Cell And Gene Therapies

  For any biotherapeutic in development today, a critical element in achieving commercialization is reducing manufacturing risk.

• The Future Of Cell & Gene Therapy: Process Improvements, Tech, & Talent

  Wade Macedone, Chief Operating Officer at Andelyn Biosciences, talks about how process improvement and operational excellence play an important role in the future of cell and gene therapies.

• Reliability And The Future Of Cell & Gene Therapies

  Reliability issues continue to persist in GMP manufacturing for the cell and gene space. Learn how companies are focusing on reliability and predictability to further advance this innovative therapy.

• What To Consider When Looking To Partner With A CDMO

  It's not just about scheduling, capacity, and terms. Read an expert's views on overlooked considerations when partnering with a CDMO and the challenges of building a new facility.

• A Proven AAV Platform To Drive Down Program Costs And Maximize Speed

  To ensure that your adeno-associated virus (AAV) therapy reaches patients as soon as possible, begin your relationship with an experienced AAV manufacturer early in the development journey.

• Overcoming The ‘Valley Of Death’ For Cell And Gene Therapy Manufacturing

  Avoiding the valley of death requires an early understanding of a drug’s proposed development process, as well as the potential pitfalls that could stall that development.

• Understanding The Gene Therapy Manufacturing Process

  Gene therapy is the process of replacing damaged or unhealthy genetic material with new material for treating diseases and conditions. Discover the manufacturing process including steps and timelines.

• Partnering At Every Stage: Providing Capable Capacity For Manufacturing

  Finding a CDMO partner with the requisite expertise, materials, external supply chain, and capacity is key to maximizing a therapy’s chances of commercial success.

• Navigating Analytical Requirements For GMP Viral Vectors

  The keys to success are establishing appropriate strategies and fundamental testing, expecting additional regulatory requests, preparing for assay variability, and ensuring comparability study preparation.

• Delivering Genetic Editing Therapies To Market

  Manufacturers with proven expertise in areas like viral vector production and analytics are needed now more than ever to get breakthrough, deliverable gene editing therapies to patients.

• Insights On Cell And Gene Therapy Manufacturing

  Since the early 1990s, gene therapy has revolutionized medicine. In the coming years, it will continue to become more relevant in the treatment and cure of some of the most severe diseases and disorders.

• Navigating AAV Vector Manufacturing

  Due to its therapeutic impact on a wide range of diseases and disorders, adeno-associated virus (AAV) gene therapy is one of the most promising advances in modern medicine.

• Early Plasmid Optimization For Long-Term Commercial Success

  Securing the right plasmid for an application can be a complex endeavor. Core to this is selecting a supplier with the quality assurance protocols and GMPs to facilitate optimized plasmid production.

• Partnering For Scalable Suspension Processes Tailored To AAV Therapies

  Achieving optimized, scalable suspension processes for adeno-associated virus (AAV)-based therapeutics comes with a number of technical and business challenges.

• Manufacturing Of Viral Vectors For Gene Therapy

  Viral vectors are essential for delivering corrected genetic information to faulty genes within affected cells and are at the heart of the gene therapy process.

• Achieving Agile, Expert Scale-Up With New Manufacturing Capacity

  Finding a manufacturing partner with the capabilities and capacity to offer truly end-to-end development and scale-up can mean the difference between successful commercialization and the end of the road.

• Implement Rapid Process Changes In Gene Therapy Manufacturing

  A clear path for establishing equivalency is needed to facilitate more rapid advances in the gene therapy field and ultimately to enable lower-cost gene therapies that reach patients faster than ever.

• The Future Of Viral Vector Manufacturing: Yield Optimization

  Ensuring optimal yield for engineered viral vectors early in a process is crucial to ensuring their eventual commercial viability and broader patient accessibility.

• Understanding The 5 Elements Of cGMP

  cGMP outlines safety procedures for every basic part of production – defining what needs to be done to keep products safe, operate machinery properly, validate processes, and maintain consistent procedures.

• In-House Plasmid Production To Secure Supply Chains

  A CDMO with in-house plasmid manufacturing capabilities can help companies accelerate timelines and ensure material availability, ultimately saving time and money throughout their product life cycle.