Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.
The transfer of a monoclonal antibody production process between scales, often referred to as scale-up or scale-down, is a difficult task. This study reviews moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform.
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.
Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.
|
|
|
|
|
|
|
|
|