Search results for " laboratory"
Article
Understanding Validation and Technical Transfer, Part I
Biopharmaceuticals are often complex molecules, or mixtures of molecules, produced in biological systems and it is not always possible to fully characterize these products in the laboratory. Therefore…
Article
Applying GMPs in Stages of Development
Virtual companies may use the services of a contract laboratory, a contract manufacturer, a contract research organization (CRO), etc., to develop their products from conception to market approval. So…
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
The laboratory of Dr. Raghu Kalluri, one of our founders at The University of Texas, MD Anderson Cancer Center focused on the knockdown of KRAS, a gene encoding a GTPase implicated in several types of…
Article
What's in Your SOP?
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
… * Business data warehouses that store information on commercial performance
* Online portals, laboratory information systems, and enterprise resource planning systems that store product qualit…
Article
Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography
Single-use systems provide replaceable fluid paths.
By Cynthia A. Challener
…
Article
From Darwin to Recombinant Fc Multimers
Topics from a Darwinistic viewpoint on how business models are evolving in the Life Science industry to breakthrough research data from Momenta Pharmaceuticals on a recombinant trivalent Fc protein …
Article
Modeling Bioreactor Performance
Model effectiveness is determined by the quality and composition of the data inputs.
By Cynthia A. Challener
Bioreactor design, including the geometry of the tank and impeller and the locati…
Article
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
Article
Affinity Chromatography Handbook: Vol. 1 Antibodies
…ration and purification of the many different forms of antibodies and antibody fragments used in the laboratory.
Download the handbook