OR WAIT null SECS
May 15, 2014
A global contract manufacturer of biologics discusses the increasing impact of health-based exposure limits in assessing cross-contamination risks.
What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär
May 14, 2014
Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.
May 01, 2014
Gallus BioPharmaceuticals enters a cell line optimization and manufacturing agreement with Omni Bio Pharmaceutical.
April 30, 2014
TAP Biosystems announced that Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.
April 02, 2014
Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.
March 02, 2014
With nanomedicines on the rise, a new class of non-biological complex drugs (NBCDs), which include nanosimilars, has emerged. As drug regulators are faced with the challenge of defining a framework to ensure the safe introduction of the follow-on nano-therapeutics, Stefan Muhlebach explains why NBCDs cannot be assessed using the standard generic or biosimilar approaches.
February 02, 2014
CMOs may find opportunities in alternative expression services.
Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.
February 01, 2014
A changing biopharmaceutical industry is going beyond typically outsourced activities and is using CMOs for more challenging processes. Review the top 10 outsourcing trends.