Search results for " process" in Articles / App Notes
Article
Microbiological Testing: Time is of the Essence
“More rapid alternatives to traditional methods are needed to speed the manufacturing process while ensuring process and product safety,” says McKee.
Protein-based biologic drugs can also present r…
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Biosimilars: Making the Switch Comes with Challenges
This is because of a lack of competition in some countries and an absence of physicians at the heart of the decision-making process to give patients access to biosimilars. In this respect, education o…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…eneca: The use of SUS removes some of the risks that would otherwise come with the required cleaning process (e.g., cross-contamination and cleaning residues). Risks that may arise with the use of SU…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
This process includes “challenging and proving non-infringement, invalidity, or unenforceability of the unexpired patents in federal court,” according to Erica Pascal, partner at DLA Piper, in GEN.
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Quality by Design and Extractable and Leachable Testing
While these materials may meet the functional goals of the container closure, if quality is considered at the beginning of the process, harmful contaminants may inadvertently be introduced into the dr…
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Technologies and Practices Must Evolve to Meet Demand
The respondents reported that they were involved in many phases of drug development and manufacturing including process development, drug-substance and finished product manufacturing, quality control,…
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Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
PDF: Contract Manufacturing Organizations (CMO’s) seem to be assuming a larger role in biopharma processing. Can you tell us why that is?
Eric: Based on our 11th Annual Report, this focus on pro…
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Raw Material Variability
Variability is when an inconsistency creeps into the material, or some unforeseen change occurs that leads to an unexpected effect on the manufacturing process. It could be a change in a chemical or p…
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Manufacturers Struggle with Breakthrough Drug Development
Such designation brings considerable FDA assistance in developing accelerated test protocols and in speeding an application through the review process. The designation also plays well on Wall Street, …
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Comparing Protein A Resins for Monoclonal Antibody Purification
As a consequence, downstream processing must accept and handle higher titers of mAbs in harvested cell-culture fluid (HCCF), and vendors of mAb purification technologies must develop chromatography re…