Bioprocessing

Bioprocessing uses a complete living cell, or their components, to obtain or create a desired pharmaceutical product. Recent scientific advancements have led to biopharmaceuticals being the fastest growing drug type, leading to rapid process and equipment advances. Below you can explore editorial articles, webinars, informational resources, and products curated to keep you up to date with bioprocessing advancements.

An interview with Lamin Jallow and Nicolas Lelievre
In its overview of rapid technologies, USP outlines user requirements and discusses issues to consider when planning to validate a rapid method. It explicitly contains information on the ATP bioluminescence detection technology that our Milliflex® Rapid System 2.0 uses for rapid sterility testing. What we have done to facilitate validation ... read more
Maintaining Contamination Control In Advanced Therapy Medicinal Product Manufacturing
In a fast-paced, rapidly evolving environment like Advanced Therapy Medicinal Product (ATMP) manufacturing, it is easy to overlook critical elements necessary to maintain contamination control. These critical and time-sensitive manufacturing procedures require a sound strategy for contamination control to help ensure the microbiological safety of ... read more
Unlocking Affordability: How Global Patient Registries Transform Affordability of Cell/Gene Therapies
Gene therapies stand at the forefront of medical breakthroughs, promising revolutionary treatment possibilities. These therapies involve manipulating or modifying genes to treat or prevent diseases, presenting a paradigm shift in healthcare. Their significance lies in the potential to address previously incurable conditions, offering hope for ... read more

eBook: Digital Sensor Technology for Real-time Diagnostics in Bioprocessing
This eBook covers a wide range of topics detailing the technologies and benefits of using digital sensors for bioprocessing applications. Specific topics covered include: reasons to switch to ISM sensors; benefits of upgrading to digital tech; oxygen measurement in fermentation and cell culture; oxygen control in bioreactors; ... read more
Analyses of Antibody Drugs Using Inert Ultra High Performance Liquid Chromatography
This article introduces analyses of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) for quality control using an inert UHPLC system that is extremely resistant to mobile phases containing high salt concentrations. By suppressing the interaction between antibody drugs and stationary phase, the system delivered ... read more
Whitepaper: QC Executive Q&A - Research and Development of Protein-Based Therapeutics
As a global provider, MilliporeSigma offers a wide range of products and services to biopharma. On the analytical side, we have a growing selection of chromatography and sample preparation products for development and QC laboratories. read more
Whitepaper: Purification Strategies for Recombinant Therapeutic Proteins
Many biopharmaceuticals are recombinant proteins obtained by biotechnological processes. In various steps of the pharmaceutical value chain, from drug discovery, to development and manufacturing, to bioprocessing, these proteins must be extracted from their complex biological sources, typically microorganisms or genetically ... read more
Whitepaper: Global regulators’ FAQs on CMC in IND/BLA filing
Mammalian cell cultures used in the manufacturing of therapeutics must be tested to ensure lack of mycoplasmal contamination. Previously, the only test for mycoplasma accepted by regulatory agencies was a culture-based test such as the test detailed in USP <63>. Currently, regulatory agencies globally accept nucleic acid testing ... read more

On-Demand Webinar: Rapid Sterility Testing as the Critical and Final Result for Product Release
In this webinar, hear from Eric Chenelle, Product Manager from Rapid Micro, as he discusses Rapid Sterility Testing as the Critical and Final Result for Product Release. read more
Considerations for Expanding Cell and Gene Therapy Cultures in Bioreactors
Learn about critical industry issues that affect the development of cell and gene therapies, including key factors within bioreactors that affect cell growth and viability of cell and gene therapy cultures. read more