Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process.
An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.
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.
The secret to performing a thorough solid-state characterization involves integrating all data that may be generated across various instruments at different laboratories and properly interpreting that data.
Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.
By establishing a platform approach to process characterization, which has supported the successful approval of several marketed biologics, AbbVie scientists ensure the entire process is robust, right first time, and results in a highly consistent product to facilitate efficient BLA filing. AbbVie’s five-step process below offers a thorough understanding of the biologic and process control strategies to help accelerate time to a robust and reliable commercial scale process.
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.
Recent developments eliminate the need for unnecessary calibrations and speed up the time it takes to do calibrations in the field.
This paper describes how to understand punch length, how to measure it correctly, and how wear affects length and tablet consistency. It also addresses the importance of specifying cup-depth tolerances.
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