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BioPharm International-05-01-2019
BioPharm International
Optimizing Diaphragm Valves to Improve Bioprocess Reliability
May 01, 2019
Features
32
5
Valve design and materials affect performance and cost to maintain.
What’s New in Upstream Technologies
May 01, 2019
Features
32
5
Recent upstream processing innovations include enhanced sensor technology, single-use bioreactors, and automated cell culture systems.
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
May 01, 2019
Features
32
5
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and enable real-time release.
FDA Faces Challenges After Gottlieb
May 01, 2019
Regulatory Beat
32
5
New agency leadership is pressed to promote innovation while addressing safety and quality issues.
Bioprocessing Facilities and FDA Inspection Problems
May 01, 2019
Perspectives on Outsourcing
32
5
FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.
The Auditor Vs. Inspector Issue
May 01, 2019
Ask the Expert
32
5
We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.
New Kit Identifies Endonuclease Impurities
May 01, 2019
Product Spotlight
32
5
The EndonucleaseGTP ELISA Kit from Cygnus Technologies detects and quantitates residual endonuclease impurities in recombinant vaccines and viral vectors used for gene therapy.
Multichannel Pipettes for 384-Well Plates
May 01, 2019
Product Spotlight
32
5
Eppendorf’s 16- and 24-channel pipettes can handle entire columns and rows of a 384-well plate in one step.
Challenges with Successful Commercialization of Biosimilars
May 01, 2019
Features
32
5
This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
Single-Use for Downstream Chromatography: Benefit or Hindrance?
May 01, 2019
Features
32
5
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
Playing the Waiting Game with GMP Guideline Revisions
May 01, 2019
Features
32
5
Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.
Managing Biologic Equipment Cleaning
May 01, 2019
Features
32
5
This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.
Formulating Biologic Drugs for Sterile Fill/Finish
May 01, 2019
Cover Story
32
5
Sterile filtration is often required for biologics but presents degradation and compatibility challenges.
Working for the Greater Good
May 01, 2019
From the Editor
32
5
Pharma delivers a positive message with renewed efforts to eradicate malaria.
BioPharm International, May 2019 Issue (PDF)
May 01, 2019
Issue PDF
32
5
Click the title above to open the BioPharm International May 2019 issue in an interactive PDF format.