BIOSTAT® B — The Gold Standard Of Benchtop Bioreactors
Sartorius Stedim Biotech introduces a revamped generation of its bioreactor series — BIOSTAT® B. This autoclavable fermentor/bioreactor is designed to cover the wide variety of requirements in biotech and biopharma research and development. It can be supplied as a flexible basic unit for preclinical research, or a pre-configured, fully qualified bioreactor system that meets GMP requirements. BIOSTAT® B is a modular system, available in single or twin. Learn more
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
As the attendees of ISPE's Biotechnology Symposium gathered in the Sheraton's Imperial Ballroom, in Durham, NC, much anticipation surrounded the event's packed schedule. The presenters included a wide range of professionals in the biopharmaceutical industry covering various topics in four tracks (to be presented over the course of two days): Biopharmaceutical Manufacturing and Process Development; Facility Design and Integration; Compliance and Process Validation; and A-VAX Case Study Understanding and Practical Applications.
By Reynaldo Roman for Marken
On December 21, 2012, the U.S. Fish and Wildlife Service (FWS) finally addressed an issue that has been of significant debate among importers of Chinese hamster ovary (CHO) cell specimens and trade experts. FWS informed the trade community that only shipments of actual CHO "cell," "cell cultures," and "cell lines" are regulated by the agency and require an import/export license for trade.
By Dan Catizone, QuickSTAT
Cold chain shipments often have to be transported to obscure parts of the world under strictly controlled temperature conditions. Making sure that clinical specimens, vaccines, drugs, or other biologicals reach their destination safely, securely, and at the right temperature is a critical element of the drug discovery process. As a shipper, you need to ensure that your "cold chain" runs efficiently and with the least amount of adverse incidents.
By Bill Swisher, Director of Business Development, Ultriva Inc.
Lean manufacturing has become the de facto best practice across most manufacturing companies. Companies that have embraced Lean principles have reduced their lead times, improved quality, lowered inventory, and engaged their employees.
By Dr. Kevin Ward, Biopharma Technology Limited
The FDA defines a generic drug as "a drug product that is comparable to a brand listed drug product in dosage form, strength, route of administration, quality and performance characteristics and intended use."
By Michael S. Heyl, MasterControl
Just imagine. Your company — hypothetically speaking — is now a successful and growth-oriented organization. Thus far, you've kept governmental regulations in check, quality is steadily improving, and you've even managed to lower the cost of production. Then, one day, the FDA shows up for an unannounced inspection of your facility.
By Mark C. Arjona, Catherine Nguyen, Jenny Y. Bang, Tom Fletcher, and Jessie H.T. Ni
In the production of biologics, various development activities require different medium requirements, calling for multiple media. Transitioning from one medium to another typically poses a certain level of risk. BalanCD™ CHO Growth A was designed as a high-performance CHO production medium for batch and fed-batch processes, however, its ability to support other cell line development activities was untested.