BioPharm International-05-01-2019

Valve design and materials affect performance and cost to maintain.

Recent upstream processing innovations include enhanced sensor technology, single-use bioreactors, and automated cell culture systems.

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.

Regulatory Beat

May 01, 2019

New agency leadership is pressed to promote innovation while addressing safety and quality issues.

Perspectives on Outsourcing

May 01, 2019

FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.

Ask the Expert

May 01, 2019

We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.

Product Spotlight

May 01, 2019

The EndonucleaseGTP ELISA Kit from Cygnus Technologies detects and quantitates residual endonuclease impurities in recombinant vaccines and viral vectors used for gene therapy.

Product Spotlight

May 01, 2019

Eppendorf’s 16- and 24-channel pipettes can handle entire columns and rows of a 384-well plate in one step.

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 technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

From the Editor

May 01, 2019

Pharma delivers a positive message with renewed efforts to eradicate malaria.

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