Search results for "manufacturing"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Problems can result when changes are made to manufacturing processes. Complexity—in particular, determining which product attributes are most crucial to product quality and patient safety—makes it cha…
Article
Science Focus Fuels Successful Process Development for Startups
The company first built an inhouse process development group to establish the optimum process, then transferred that final process to a contract manufacturing organization.
SQZ Biotech, after deba…
Article
Biopharma Says It Has an Evolution in New Technologies and Processes
For example, FDA has been an active proponent of continuous manufacturing for small-molecule drugs. Now that several drugs manufactured via continuous processing have been approved, the interest in th…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
The roadmap focuses on biomanufacturing strategy over a 10-year timeframe and defines the needs of, challenges to, and potential solutions for the industry. With a diverse pool of participants from in…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
The purpose of these guidance documents is to promote enhanced understanding of products and processes, to build quality into manufacturing, and to provide the basis for continuous improvement of prod…
Article
Best Practices for Data Integrity
By Jennifer Markarian
Maintaining data integrity is essential for all biopharmaceutical manufacturing operations. BioPharm International interviewed Dan Nelson, Customer Expe…
Article
Innovation vs. Capacity: How CMOs Compete
The contract and manufacturing organization (CMO) industry can be segmented along obvious lines such as API versus drug product manufacturers, biologics versus small molecule, dose form(s) manufacture…
Article
Lessons Learned Accelerate Vaccine Development
“The lack of true platforms, with a few exceptions, means that there is a lack of standard cell lines with associated process and analytical frameworks for the manufacturing and release of products,” …
Article
Aseptic Processing: Keeping it Safe
Although packaging failures factored into a majority of the “lack of sterility assurance” cases, many of the remaining contamination cases were associated with GMP issues or manufacturing errors such …
Article
Breakthrough Drugs Raise Development and Production Challenges
New drug applications (NDAs) for breakthrough therapies often contain less manufacturing information than usual, requiring innovative risk-mitigation strategies to ensure product safety. Agency review…