Search results for " drug"
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
The stability of aseptically filled drugs will be affected by a variety of factors. Because aseptic filling requires close coordination and involves complex interaction between personnel, sterilized p…
Article
Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …
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
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Managing Risk in Biomanufacturing
With patients’ lives dependent on a continuous supply of high-quality drugs and vaccines, it is essential to have consistency within the industry on how to manage risks. Today’s business environment r…
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
To support this development, mAbxience, a Spanish biotechnology company specialized in research, development, and manufacture of biosimilar drugs, is committed to provide the manufacturing of highqua…
Article
Extractables Studies for Single Use Systems Used in ADC Manufacturing, Part 1
Single‑use (SU) systems have great potential in antibody‑drug conjugates (ADC) manufacturing. The use of organic solvents in the ADC process might , however, raise questions about potential leac…
Poster
Collaborating to address the bioburden challenge
Bacteria and their byproducts can negatively affect the safety and potency of a biopharmaceutical drug. At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batche…
Article
Automating Bioprocesses
… bioprocessing, although it is in its infancy compared to continuous manufacturing of small-molecule drug products. There are several licensed products that use a continuous perfusion process upstrea…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Formation of protein aggregates and subvisible particles during the manufacturing of drug products are a major concern due to the potential immunogenicity of protein aggregates in patients (17–22). Th…