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Current Issue
Particle Analysis Techniques Help Meet Regulatory Requirements
An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.
A Novel Metric for Continuous Improvement During Stage Three
How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
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
Woodcock Sees Future for Precision Medicine
In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.
Data Integrity and Quality Problems Found at China Facility
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
EMA Recommends Restrictions on Multiple Sclerosis Medicine
The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.
Webcasts
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