Andreas M. Beckhaus

Nov 12, 2024 | outsourcedpharma.com | Louis Garguilo |Drew N. Kelner |Andreas M. Beckhaus |A Focus

Put Your AAV On The Fast-Track To The ClinicAdvancements in molecular biology and viral therapy over the last 30 years have enabled rapid progression in the gene therapy space. Viral vectors, most notably lentiviruses, adenoviruses, and adeno-associated viruses (AAVs), are regularly used as gene delivery vehicles in gene and cell therapies. To meet the increasing demand for AAV gene therapies, developers and manufacturers must successfully navigate the challenges of AAV production. Learn more now.

Oct 17, 2024 | bioprocessonline.com | Drew N. Kelner |Andreas M. Beckhaus

Guest Column | October 17, 2024 By Drew N. Kelner and Andreas M. Beckhaus, ProDeMaCon LLC Consulting In part 1 of our article series about “particular problems” in cell therapy products, we focused on extrinsic and intrinsic particles and provided recommendations on how a cell therapy manufacturer can create a risk management strategy. Part 2 focuses on the third type of particle class,1 inherent particles.

Oct 17, 2024 | cellandgene.com | Drew N. Kelner |Andreas M. Beckhaus

Guest Column | October 17, 2024 By Drew N. Kelner and Andreas M. Beckhaus, ProDeMaCon LLC Consulting In part 1 of our article series about “particular problems” in cell therapy products, we focused on extrinsic and intrinsic particles and provided recommendations on how a cell therapy manufacturer can create a risk management strategy. Part 2 focuses on the third type of particle class,1 inherent particles.

Aug 28, 2024 | cellandgene.com | Andreas M. Beckhaus |Drew N. Kelner |Junwei Sun |Lucia Fernandez |Lucia Fernández

The High Cost Of Going CheapDevelopers often aim to cut expenses during development. Discover the long-term outcomes of cost-effective measures like using RUO leukopaks compared to investing in high-quality GMP-grade vectors. As most cell therapy products are administered intravenously, they need to comply with requirements for particulate matter. This article shares risk mitigation steps and strategies for testing and release.

Aug 19, 2024 | cellandgene.com | Andreas M. Beckhaus |Drew N. Kelner

By Andreas M. Beckhaus and Drew N. Kelner, ProDeMaCon LLC Consulting As most cell therapy products are administered intravenously, they need to comply with the compendial requirements for particulate matter. USP<1&GT1 requires that each final container shall be inspected to the extent possible for the presence of observable foreign and particulate matter and that the limits for subvisible particulate matter set forth in USP <788&GT2 are met.