Finding Opportunities in Brazil
Changes in the country’s political landscape may affect the pharmaceutical industry market in the future.
Behind the Scenes with Buffers
They may not be glamorous, but buffers play an important role in biopharma manufacturing.
Colony Counter Increases Accuracy
Protos 3 is Synbiosis’ automated colony counter and chromogenic identification system.
Peristaltic Pump Ensures Repeatability
Watson-Marlow’s 120 cased peristaltic pumps are designed for single-use systems that require no contamination.
Tackling Analytical Method Development for ADCs
As ADCs move through the drug-development process, different analytical methods are often required.
Cures Require Compromise
Initiatives to speed drug development must pass Congress and special interest groups.
Mitigating Risk for Single-Use Assemblies in Sterile Filling
Evaluating the assembly design process, manufacture, and use helps mitigate risk.
FDA Sets Policies to Enhance Drug Security and Safety
Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.
Gauging the CMO Biosimilar Opportunity
Market forces may limit the success of CMOs.
The Bullish Outlook for Biosimilars
Investors are lining up for the biosimilars market as patents reach expiration and regulatory pathways are defined.
Equivalence Testing for Comparability
Understanding the influence of change events on product performance is a necessity to routine drug development, transfer, and validation.
Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Rapid Early Process Development Enabled by Commercial Chemically Defined Media and Microbioreactors
The use of commercially available media to achieve high titer in early process development is discussed.
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
BioPharm International, February 2015 Issue (PDF)
Click the title above to open the BioPharm International February 2015 issue in an interactive PDF format.
