Search results for " industry"
Article
Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
It has still not been possible to use the industry standard 1.0 M NaOH solution during cleaning-in-place (CIP) or sanitization-in-place (SIP).
Productivity of the Protein A step is also a challen…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Mammalian cells meet these criteria quite efficiently by virtue of their post-translation modification system, and this has made them a dominant production system for the biopharmaceutical industry. M…
Article
N-Glycan Analysis of Biotherapeutic Proteins
…tools into focus, involving software engineers, computer scientists, chemists, and biologists across industry and academia. Combined, these factors could power glycomic analyses at a similar rate as …
Article
Improvements in Protein A Chromatography
Bolton recently published a paper “Role of more than 40 years of improvement in Protein A chromatography in the growth of the therapeutic antibody industry,” and also presented at the spring ACS meeti…
Article
Being Thorough When Transferring Technology
For example, when single-use bioreactors were a nascent technology to the industry, there were reports that some bags melted on the larger bioreactors. Someone didn’t anticipate the heating and coolin…
Article
Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success.
By Cynthia A. Challener
Next-generation antibodies are designed to be more specific and are ofte…
Article
Ensuring Sterility in Small-Scale Production
FDA, Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing, Current Good Manufacturing Practice (CDER, September 2004).
2. Parenteral Drug Association, Technical Report #62, …
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
There is also a growing interest in the pharmaceutical industry to develop small-scale models to study the potential impact of large-scale freeze-thaw process variables on protein stability. The small…
Article
Biosimilars to Drive Modern Manufacturing Approaches
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch additional programs to develop competitive biotech therapies, regulatory authorities and in…
Poster
Improve operational efficiency in biomanufacturing with comprehensive automation solutions
In the biopharmaceutical industry, process data is used in multiple ways throughout process development and the different production phases. However, equipment used are often connected only by proce…