Search results for "manufacturing"
Article
Challenges in Analytical Method Development and Validation
BioPharm International spoke with Krumenaker, Krause, Guo, and Smith about the challenges involved in analytical method development and validation in biopharmaceutical manufacturing.
Biopharmac…
Article
Track-and-Trace Progress Benefits Supply-Chain Security Efforts
…ta electronically using electronic product code information services (EPCIS) to capture events from manufacturing to serialization [and] capping to shipping.EPCIS can capture those key events and sha…
Article
Innovative Chromatography Resins Can Improve Purity and Quality
With ongoing efforts to increase monoclonal antibody (mAb) productivity in large-scale biomanufacturing, biomanufacturers continuously seek advancements in downstream processing technologies, with dow…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
What are some key guidelines for biopharma companies to follow?
Steven Lynn: I think, first off, it depends on where the company is manufacturing and marketing their products. From the US persp…
Article
Automating the Biomanufacturing Process
Automation has traditionally focused on controlling the manufacturing process throughout production to ensure that product remains identical between batches. Control has been manifested mainly in mini…
Article
Scaling Up Novel Therapies
The key to making gene therapy accessible to patients will be better manufacturing processes, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, told attendees at the Galien …
Article
The Challenge of Disruptive Technologies in Bioprocessing
… growing R&D expenditure in biopharma companies are factors driving the growth of the global biomanufacturing industry, including downstream bioprocessing,” adds Orjana Terova, product manager, downs…
Article
Making the Move to Continuous Chromatography
“Multicolumn chromatography has long been an accepted continuous purification practice by small-molecule manufacturers, but is just now gaining traction in the biomanufacturing space,” he says.
…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Similar cell-culture media may be used simultaneously in one or few biological processes at a drug product manufacturing facility. As per Code of Federal Regulations (CFR) 211. 84, each media needs to…
Article
Selecting a Comprehensive Bioburden Reduction Plan
By Randi Hernandez
There are multiple variables to consider in the reduction of bioburden, including the evaluation of microbes in a facility, in the manufacturing process, and in the materials us…