The Necessity of Extractables and Leachables Qualifications for Lyophilized Drug Products: Some Fallacies Addressed.
When selecting and qualifying the primary packaging for lyophilized drug products (LDPs), a fundamental question arises: How...
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N-Nitrosamines in Primary Packaging for SVP’s
Recent product recalls due to the unexpected presence of N-Nitrosamines have highlighted the critical need to understand...
Do’s and Don’t in setting up Extractables and Leachable Studies, taking into account Existing Standards Guidelines and Recommendations
During the production, storage, distribution, and administration of small volume parenteral (SVP) drug products, chemicals can leach...
Combination Products and Parenteral Packaging: A Notified Body (EU) Perspective
This presentation at the 2022 Nelson Labs Virtual Symposium will provide a comprehensive overview of the considerations...
Manufacturing an SVP Drug Containment Solution: Quality by Design
The 2022 Nelson Labs Virtual Symposium will offer an in-depth look at the considerations necessary when choosing,...
Polymer-based, Pre-filled Syringes designed to Minimize the Aggregation Risk of Sensitive Biodrugs
Biopharmaceutical drugs offer new therapeutic solutions to numerous human diseases and conditions. However, these advanced therapies come...
Rubber Manufacturing and Composition of Pharma Rubbers
Rubber closures are a critical component in the primary packaging system of small volume parenterals (SVPs). At...
Combination Products and Parenteral Packaging a US Perspective
This presentation at the 2022 Nelson Labs Virtual Symposium will provide a comprehensive overview of drug delivery...
FDA Medical Device Inspections in the Post Pandemic World
The FDA is ramping up its inspections of medical device manufacturing facilities. Are you ready? Since March...