Search results for " safety" 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…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…ements for Pharmaceuticals for Human Use (ICH) Q6B (8), and could have potential implications on the safety and efficacy of the intended products. In addition, the integrated transgenes may be partia…
Article
Best Practices in Qualification of Single-Use Systems
…h do not negatively impact the end user’s biomanufacturing process and/or drug product quality and safety. To achieve this goal, technical transparency is essential. During the visit, the technical t…
Article
Host-Cell Protein Measurement and Control
The amount of residual HCPs in drug product is generally considered a critical quality attribute (CQA), due to their potential to affect product safety and efficacy. Therefore, it is a regulatory requ…
Article
Global Expansion Shapes Drug Oversight
…lly changing global marketplace” and its “huge implications” for FDA’s ability to ensure the safety and quality of products manufactured elsewhere. To better assess product risks, Hamburg proposed “e…
Article
PDA's Technical Report for Biotech Cleaning Validation
For nonbiotech applications, limits for the active ingredient are typically established using a carryover calculation, which is based on the safety or toxicity of the active ingredient. For the manufa…
Article
Advances in Engineering of Protein-Based APIs
Fully human mAb therapeutics with fully human sequences have reduced immunogenicity potential and improved safety and efficacy, enabling chronic treatment without liabilities, according to Jennitte St…
Article
Biopharma Seeks Balance
…s and processes within the Office of New Drugs; improved knowledge management; a unified post-market safety surveillance framework to monitor the benefits and risks of drugs before and after approval…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
By Feliza Mirasol
Aseptic filling is a crucial process in biopharmaceutical manufacturing because it has a potential safety impact on the end user and because aseptic filling is a highly tec…
Article
Impurity Testing of Biologic Drug Products
“Whilst removal or inactivation of these agents is considered under the production process validation as a safety issue rather than tested in the final product as a quality concern, these agents can a…