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.
Author Archives: BPI Contributor
New Downstream Harvest Options Using Custom Designed Disposable Resins
Engineered affinity resins create the ability to produce functional proteins on a solid support in vivo which can lower production costs, improve flexibility and increase scale up speed.
Next Generation PEGylation Technology
Decreases in the immunoreactivity of next generation PEGylated drugs may be attainable by the use of monofunctionally activated hydroxyPEGs instead of methoxyPEGs in their synthesis.
Single-Use Depth Filtration for Mammalian Cell Culture Clarification
Clarifying cell culture broth is the first downstream unit operation in an elaborate sequence of steps required to purify a biological therapeutic. A combination of centrifugation, depth filtration, or tangential-flow filtration (TFF) is used for that operation. The availability of large-scale, single-use, depth filtration technology in the recent years, however, has given process developers the capability to improve and simplify downstream processes.
New Technology for Broad Screening of Cell Microbial Contaminants, Including Viruses
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.
Implementation of a 2000L Single-Use Bioreactor and Clarification System at an Existing cGMP Facility
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.
Manufacturing Roundtable: Building Biomanufacturing Expertise in Emerging Markets
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.
cGMP Operational Excellence and Infrastructure Harmonization from Lab to Plant
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.
Special Events
SYMPOSIA ON MONDAY, 8 OCTOBER 2012, 1:00–5:00 PM #1: Biosimilars: Defining Successful Development Strategies in an Evolving Regulatory Environment #2: Best Practices for Implementation Challenges with Single-Use Systems #3: Best Practices in Managing Variability of Raw Materials #4: Regulatory Requirements in Preclinical CMC Development #5: Best Practices in Cleaning and Cleaning Validation: A Science-Based and Integrated Approach for Biopharmaceuticals #6: Risk Management in Fill–Finish Operations #7: CMC Project Management throughout the Product Development Life Cycle #8: Microbial Protein…
Thermo Fisher Hosts a Series of BioProcessing Seminars
Thermo Fisher Scientific wrapped up its North American series of BioProcessing Technology Seminars in June 2012 in North Carolina. Over two months, the company and local biomanufacturers hosted six all-day events at different venues focusing on cell culture media design, single-use systems, bioreactor technologies, and performance optimization. Agendas included interactive presentations from industry experts and typically ended with a tour of a local bioprocessing facility. On 21 June in Cambridge, MA, Eric Langer (BioPlan Associates) kicked off the fifth meeting…