Search results for " outsource"
Article
What's in Your SOP?
They are many virtual and small companies that outsource much of their operations. US 21 Code of Federal Regulations (CFR) 200.10 discusses the relationship between a contract provider and a contract …
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
Buffer Management Solutions for Large-Scale Biomanufacturing
Learn how different approaches can resolve buffer management challenges in large-scale biomanufacturing. This article discusses solutions such as inline conditioning, outsourcing buffer preparation,…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.
By Feliza Mirasol
Aseptic filling is a crucial process in biopharmaceutical …
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…
Article
Drug Discovery and Development in India
Apr 01, 2015
By Jane Wan
BioPharm International
Volume 28, Issue 4
Indian pharmaceutical companies’ entry into the drug discovery and development field dates back to the early 1990s …
Article
Advancing QbD in the EU
In a discussion paper issued in late 2012, the agency pinpointed the need for tighter controls on outsourced manufacturing to ensure that it is GMP compliant. EMA also thought that details of the "pre…
Article
Discovering the unknown: How does in silico process development change PD scientists’ work?
As resources are sometimes limited, an alternative strategy that is taken by some customers is actually to outsource modeling activities to Cytiva and to use the expertise that we have here at Cytiva …
Article
Developing oligonucleotide therapeutics with confidence
In this video, we will look at key considerations for oligo therapeutic developers entering the market, such as scalability, flexibility, regulatory concerns, insource/outsource consideratio…