In order to deliver cell-based therapies on a commercial scale, cell therapy companies and suppliers must form partnerships in order to overcome existing manufacturing, regulatory, and analytical challenges. Four leading cell therapy experts discuss what is and what has to be done in order to accomplish this objective.
Promethera Biosciences presents this case study detailing how HHALPC from normal adult livers can be purified, expanded In vitro and utilized to successfully treat patients with Crigler-Najjar disease.
The technological innovations and improvements to cell purification and other cellular analysis-based processes have dramatically increased sample throughput rates resulting in an improved ability to treat cancer, autoimmune diseases, and a range of applications in regenerative medicine.
While cell-based therapies offer huge potential, significant challenges, including GMP manufacturing, scaling-out, and delivery must be addressed and overcome in order to justify and successfully autologous and allogeneic provides to the market.
In order for cell therapy companies to successfully evolve from R&D to commercialization, there are many lessons learned from the protein business that can be applied to the cell therapy market.
Two case studies are presented highlighting the impact PLEX-ID System can have to rapidly identify virus contaminants resulting in better control of biologics manufacturing process, with the potential to characterize various sources of excursion through genotyping information.
This case study highlights a seven month project to upgrade a 100L stainless steel facility to a 2000L single-use facility without affecting current clinical manufacturing while adhering to cGMP requirements.
The mainstream adoption and success of mobile, single-use manufacturing platforms, combined with the introduction of off-site training programs provide companies with the ability to quickly set up and operate fully functioning biomanufacturing facilities globally.
This presentation outlines the key issues facing the R&D and Quality cGMP environments and presents key IT-based solutions that have been implemented by leading pharma and biotech companies.
Process development engineers are responsible for developing scale-up strategies for efficient and cost-effective manufacture of biological and bioprocess-derived products at bench-scale, pilot scale and at manufacturing scale. A central unit operation in the production of these various therapeutic proteins is cell clarification using depth filtration. Recently, single-use depth filtration technologies have been developed, at scales ranging from the lab, to R&D, process development and on to manufacturing.
In this educational webcast, Laura Brown, Scientific Application Support Specialist II with 3M Purification, will provide guidelines for scaling-up of single-use depth filtration systems, and will review the commonly used single-use depth filtration products used for biopharmaceutical manufacturing.