This FAQ explains how aseptic processing, contamination control, and validation protect patients amid sterile injectable failures.
|Articles|June 15, 2015
- BioPharm International-06-15-2015
- Volume 2015 eBook
- Issue 1
QRM Tools for Contract Biomanufacturing
Author(s)Bikash Chatterjee
Quality-risk management tools can assist biopharma companies in mitigating risks when outsourcing crucial elements of the drug-development process.
Advertisement
For decision making and overall program risk reduction, a quality-risk-management (QRM) program is an effective means for biotech companies to mitigate the risks associated with outsourcing crucial elements of the drug-development lifecycle. Risks only get larger when activities typically performed internally during the development process are outsourced to a contract service provider.
Articles in this issue
over 11 years ago
Fill/Finish Trendsover 11 years ago
Biopharma Advances Demand Specialized Expertiseover 11 years ago
Protecting Intellectual Property in Engagements with CMOsover 11 years ago
Taking a “Development-by-Design” Approach to Cell TherapiesAdvertisement
Related to this article
Johnson & Johnson's amivantamab (Rybrevant Faspro) won accelerated FDA approval for pretreated recurrent head and neck cancer.
FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.
Akeso won NMPA priority review for ivonescimab plus chemotherapy in first-line biliary tract cancer after a phase 3 win over durvalumab plus chemo.
VG801 gene therapy improved vision through 12 months in a Stargardt disease trial as VeonGen aligned with FDA on its pivotal phase 3 design.
Final FDA guidance replaces 2011 potency testing advice, asking CGT makers to build potency assurance from IND filing through postmarket monitoring.
CAR-T transformed blood cancer care, but solid and brain tumors demand different delivery, manufacturing, and safety strategies to work.
Advertisement
Advertisement
Trending on BioPharm International
1
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
2
AstraZeneca Acquires Omniose, Adding Bioconjugate Vaccine Platform
3
J&J’s Dual-Antigen Bispecific Regimen Achieves 73% PSA Response in Advanced Prostate Cancer
4
argenx Agrees to Buy Unnatural Products in Up to $1.15 Billion Deal
5