SciLog’s MabTecâ„¢ is an add-on bioreactor maintenance system that can gravimetrically manage, automate, and document your bioreactor feeding or perfusion strategy. The MabTecâ„¢ upgrades many manual processes to walk-away automation with minimal investment in terms of capital or time. Summary MabTecâ„¢ combines accuracy with convenience to provide an ideal solution for cell culture feeding strategies. Based on the results, MabTecâ„¢ demonstrated the ability to increase protein production while eliminating several hours of manual daily operation.…
2012
Bio on Demand
NNE Pharmaplan has developed a new facility concept we call Bio on demandâ„¢. Facilities based on the Bio on demandâ„¢ concept can be established in one to two years. The result is a flexible facility that is fully operational, locally compliant, and with functioning quality systems. The Bio on demandâ„¢ concept involves a high degree of single-use technology to ensure cost-effective production and fast establishment. Facilities based on our Bio on demandâ„¢ concept can be delivered globally,…
High-Throughput 96-Well Osmolality Determinations
As the pharmaceutical industry focuses on developing biological drugs derived using cell culture processes, the ability to optimize the growth, health, and potential yield of the cell line becomes increasingly important. Finding the optimal cell culture media is a daunting and time-consuming process due to the amount of potential media components and the unique requirements of the cell line being researched. Osmolality information is a crucial component to this research because of its close relationship between cells…
Automated, Nondestructive, Rapid Microbial Testing
Automated, nondestructive, rapid sterility and environmental monitoring () Rapid microbial testing methods continue to gain acceptance in pharmaceutical manufacturing, but experience shows that most companies still use traditional methods for their testing. The ability to deliver results in less time than traditional methods provides compelling benefits to manufacturers. Two key areas of microbial testing where these benefits can be realized include environmental monitoring and sterility testing. Microbial testing must be completed throughout the manufacture of pharmaceuticals, including the raw materials…
Looking at the Recent FDA Biosimilar Guidelines
Small-molecule treatments are invaluable in providing symptomatic benefits for an array of illnesses. However, many serious conditions — ranging from cancer to autoimmune disorders — respond better to more sophisticated complex drugs such as therapeutic biologics and nonbiologic complex drugs (NBCDs). The latter are medicinal, nonbiological products in which the active substance is not a homomolecular structure, but rather consists of a number of different (closely related) structures that cannot be fully characterized. The US Food and Drug Administration (FDA)…
From the Publisher and Editor
At about this time of the year, 10 years ago, the four founders of BioProcess International were in arguably the most creative period of their lives. By the middle of 2002, we began designing our collaborative production and operating processes with our new Informa colleagues (then Eaton Publishing). We were assembling author and advertising contacts pretty much from scratch, trading opinions about page designs, building a manuscript pipeline, choosing fonts (something those outside of publishing might not…
Spotting, Tracking, and Predicting Inspection Trends
Compliant companies, to paraphrase Tolstoy, are all alike. Every noncompliant company seems to find its own way to fall short of compliance with good manufacturing practice (GMP) and come, as did the writer’s famous heroine Anna Karenina, to grief. One commonality of compliant firms is that most seem to have excellent self-auditing/self-inspection programs. Indeed, many inspectors say that a primary predictor of a compliant company is a rigorous self-inspection program. Such a program is appropriately focused, adequately resourced,…
A Decade of Production
Single-use technology has arguably been the biggest “story” of the past 10 years in bioprocessing. And for many people, implementation of disposable elements began soon after the turn of the century with a bioreactor (1, 2), first developed by Wave Biotech in 1996, now a mainstay of many upstream process development laboratories and sold by GE Healthcare. BPI identified the significance of such technologies early on, making them the subject of a supplement in its second year. By the fourth…
Bioreactor Design and Bioprocess Controls for Industrialized Cell Processing
It’s official: The “Age of Cell Therapy” has arrived. A robust pipeline of cell therapies, with increasing numbers of both early- and late-stage clinical trials as well as FDA-approved commercial products that have entered the market already, strongly indicates that the cell therapy industry is poised to emerge as a distinct healthcare sector (1). Renewed investor interest and recent activity among major pharmaceutical companies suggest that this industry will rapidly develop the capability and capacity to be a highly competitive,…
A Decade of Bioreactor and Upstream Technologies
A high-quality product begins with efficient upstream process equipment. Ten years ago, manufacturers were still warming up to single-use bioreactors, which were mainly rocking-bag–based solutions. The benefits relating to cleaning and validation were clear, but their use as bioreactor vessels was still new, and stainless steel systems up to 20,000 L in scale were still needed. Today’s facilities are a hybrid of sophisticated single-use components and stainless steel equipment, the mechanisms of both having undergone improvement during the past decade.…