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.

Is the Timing of the Microbial Release Testing of Drug Products Important?
The authors have become aware that regulators, especially during site inspections, are beginning to ask questions about whether pharmaceutical manufacturers have considered setting time limits from the date of manufacturing to the microbial release testing of their finished drug products. Although good manufacturing practice regulations, guidance ... read more
Shifting Sands: From Sensitivity to Accuracy in Bioanalysis
In recent years, regulatory focus has notably shifted from sensitivity to accuracy, underscoring a pivotal change in how we approach toxicological assessments. While sensitivity remains a critical requirement, our advancing understanding of toxicology has highlighted the crucial need for precise target analysis. This shift in focus is particularly ... read more

Single-Use Process Platforms Help Biomanufacturers Reduce Costs
There are many new challenges facing those involved in the manufacture of biopharmaceuticals. read more
Automated Purification of Residual DNA Using the PrepSEQ™ Residual DNA Sample Preparation Kit and the MagMAX™ Express 96 Instrument
Biopharmaceuticals produced in live cell systems such as bacteria and eukaryotic cell lines contain some level of host cell DNA at the time the product is harvested from bioreactors. The host DNA constitutes a potential threat to human health, and manufacturing regulations stipulate that host DNA must be below a certain level in... read more

Improving Environmental Monitoring Sampling Workflows Through Paperless Operations
Paperless sampling operations offer opportunities for more standardized documentation practices and streamlined EM workflows, improving documentation management, transcription accuracy, process visibility, and review efficiency over traditional paper... read more
Cleaning & Disinfection in Biopharma: Cutting Contamination Risk
As biopharmaceutical processes become more biologically complex and operationally interconnected, the impact of contamination events continues to grow. Cell and gene therapies, multiproduct facilities, single-use systems and accelerated timelines ... read more
Implementation of Global Microbiology QC Automation at Amgen
In this webinar learn how Amgen transformed its global QC Microbiology operations by implementing the Growth Direct® platform to fully automate in-process bioburden, water bioburden, and environmental monitoring testing. read more