Insourcing vs Outsourcing: Choosing the Right Strategy
Aseptic manufacturing is an important part of drug development and commercialization that must be approached with utmost care and attention to detail. Getting a drug product packaged and passing successfully through clinical manufacturing and into the marketplace will depend on many factors, some which are fundamental and straightforward while others require careful consideration of different criteria that can affect each individual situation. The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.
Read this article from BioPharm International’s 2017 Outsourcing Resources eBook.
View other articles in the 2017 Outsourcing Resources eBook.
| ||||||||||||||||||
| ||||||||||||||||||
|
|---|
|
Current Issue
STR Profiling: Authentication of Human Cell Lines and Beyond
Short tandem repeat profiling is the most validated method to confirm cell line identity and avoid misidentified or cross-contaminated cell lines.
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
Laboratory Data Integrity Benefits from Electronic Systems
Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.
Outsourcing
Contract Manufacturing Through the Years
How has the bio/pharmaceutical contract manufacturing industry evolved and changed over the years and what does the future hold?
CordenPharma, GE Healthcare Partner to Speed Development
GE Healthcare’s Dharmacon business and CordenPharma contract manufacturing enter a strategic collaboration to accelerate the oligonucleotide development process.
Lonza Completes Capsugel Acquisition
A $5.5 billion acquisition brings Capsugel’s oral dosage delivery capabilities to Lonza’s portfolio.
Patheon Invests $45 Million in Facilities
Patheon will add spray drying, sterile manufacturing, and packaging capabilities to four facilities.
Standards/Regulations
Industry Groups Applaud House Passage of FDARA
BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.
FDA Warns India Facility Over Sterility Failures
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
Woodcock Sees Future for Precision Medicine
In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.
Webcasts
Sponsored Links
