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BioPharm International-06-01-2016
BioPharm International
Watch Out for the Hangover
June 02, 2016
Perspectives on Outsourcing
29
6
Acquisition binges often lead to hangovers; here’s what to watch out for.
Scale-Up of Complex Biologics
June 01, 2016
Cover Story
29
6
Scale-up of complex, innovative products requires commercialization models that are sustainable.
Essentials in Tolerance Design and Setting Specification Limits
June 01, 2016
Analytical Best Practices
29
6
Specification limits should be set early in drug development and refined in later phases as data becomes available.
Make Data Integrity Integral to CGMP Training
June 01, 2016
Ask the Expert
29
6
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.
Continued Process Verification: State of the Industry
June 01, 2016
Manufacturing Best Practices
29
6
An understanding of continuous process validation can lead the way to consistent approaches, reduced investigation times and observations, the avoidance of lost batches, and high-quality products.
Scaling Up Progressive Expression Systems
June 01, 2016
Features
29
6
Barriers to the production of biopharmaceuticals in moss are explored.
Bioprocessing Technology Marches On
June 01, 2016
From the Editor
29
6
Advances in single-use systems, consumables, and continuous manufacturing show steady progress.
Controlling Glycosylation for Improved Product Quality
June 01, 2016
Features
29
6
Advances in cell line engineering, process optimization, and in-vitro glycosylation are making a difference.
Modern Manufacturing Comes of Age
June 01, 2016
Regulatory Beat
29
6
FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.
Biosimilars: Making the Switch Comes with Challenges
June 01, 2016
Regulatory Beat
29
6
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
Acoustic Separator Streamlines Clarifications
June 01, 2016
Product Spotlight
29
6
The Cadence Acoustic Separator (CAS) from Pall Life Sciences enables the purification of bioprocesses fluids without the use of primary depth filters or centrifuges.
Sensors Allow for Bluetooth Connectivity
June 01, 2016
Product Spotlight
29
6
The ArcAir communication package from Hamilton Company enables Bluetooth 4.0 wireless connectivity in all environments.
BioPharm International, June 2016 Issue (PDF)
June 01, 2016
Issue PDF
29
6
Click the title above to open the BioPharm International June 2016 issue in an interactive PDF format.
The Evolving War on Drug Prices
April 29, 2016
Global Report
29
6
Immuno-oncology drugs are demonstrating patient benefits, but growing resistant to the high cost has implications for patients, market access, and manufacturers.
Headspace Moisture Analysis for Determination of Residual Moisture Content in Lyophilized Pharmaceutical Products
April 01, 2016
Downstream Processing
29
6
Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.