BioPharm International-06-01-2018

Ask the Expert

June 01, 2018

Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

More advanced NGS-based techniques still require validation and regulatory acceptance.

Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.

FDA and Congress seek to limit the production and distribution of pain medicines.

Perspectives on Outsourcing

June 01, 2018

New and expanded facilities point to the continuing growth of the biopharmaceutical industry.

This article discusses affinity capture for tier determination and surveys a broad collection of commonly and less commonly used assays to analyze cell culture media

Product Spotlight

June 01, 2018

Endress+Hauser’s Field Xpert SMT70 is a tablet PC suited for commissioning and maintaining field instruments in hazardous and non-hazardous locations.

Product Spotlight

June 01, 2018

The ÄKTA pilot 600 from GE Healthcare is a lightweight bench-top chromatography system suited to streamline both GMP and non-GMP everyday operations.

Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.

Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.

Logistics manufacturers are adapting to explosive growth in the use of direct-to-patient clinical trials. Michael Sweeney, director of patient-centric logistics at World Courier Group, discusses the new model’s impact.

From the Editor

June 01, 2018

By minding gaps in industry knowledge, bio/pharma companies can avoid development pitfalls.

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.

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