Confirmation of raw material quality is a vital part of biopharmaceutical manufacturing processing. Incorrect or poor-quality vendor materials account for a considerable portion of failed and recalled product. To prevent these expensive problems, strict quality control (QC) procedures are often implemented and used to screen for inappropriate incoming materials. QC procedures commonly used are chemical tests that involve removing samples to a laboratory and performing, which can at times be complex, time-consuming, and laborious protocols. A common test procedure that…
May 2011
Productivity Bottlenecks Drive the Demand for Innovation
Spending is up, the global economy is slowly getting back on track, and the biopharmaceutical industry continues to roll along at double-digit growth. Productivity has been the primary industry focus over the past few years, and it remains a hot topic. Companies are aggressively going after the bottlenecks to their efficiency, and now they’re opening their wallets to fix what’s broken. One of the biggest productivity fixes today centers on improved single-use devices and systems. They top a…
Working with a Powerful and Robust Mixed-Mode Resin for Protein Purification
Orthogonal methods for assuring robust downstream purification are critical to today’s demanding downstream process industry. Regulatory scrutiny on the immunogenic propensity of drugs has increased and broadened over the past two decades. Although immunogenicity can come from a number of sources, common concerns include host-cell proteins and aggregates. Constantly lurking in the background are other issues such as viral clearance, DNA levels, and so on. Those problems can be addressed simultaneously with the mixed-mode chromatographic support known as…
Global Marketplace
Shaker–Incubator Product: Multitron II system with shaker-bag option Applications: Cultivation of mammalian, insect, or plant cells Features: A Multitron II unit (50-mm orbit) with shaker-bag option enables 1- to 10-L cell cultures in disposable bags. Direct gassing of air or air–CO2 mix provides pH stability, and media temperature is controlled by air inside the incubator chamber. Up to three 2-L or two 10-L bags, or one 20-L bag from a number of manufacturers can be accommodated. The system also works…
Disposable Bioreactor Sensors Play Catch-Up
The evolution of single-use bioreactor (SUB) systems in biologics manufacturing has been rapid and influential. Reliance on efficient and flexible bioreactor technology will be critical for reducing scale-up costs and facility capital expenses as well as aggressively growing biotherapeutic and monoclonal antibody production. The biopharmaceutical industry has seen considerable growth in the proliferation of single-use bioreactor platforms as well as manufacturing areas where these systems are applied. Need for Improved Single-Use Sensors As disposable technologies are widely accepted and established,…