BioPharm International June 2018

June 2018 | Volume 31, Issue 6
BioPharm International June 2018 Issue
Issue PDF
By BioPharm International Editors
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Cover Story
Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.
Features
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.
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.
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.
Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.
Perspectives on Outsourcing
By BioPharm International Editors
New and expanded facilities point to the continuing growth of the biopharmaceutical industry.
Regulatory Beat
FDA and Congress seek to limit the production and distribution of pain medicines.
From the Editor
By minding gaps in industry knowledge, bio/pharma companies can avoid development pitfalls.
Ask the Expert
Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Product Spotlight
By BioPharm International Editors
Endress+Hauser’s Field Xpert SMT70 is a tablet PC suited for commissioning and maintaining field instruments in hazardous and non-hazardous locations.
By BioPharm International Editors
The ÄKTA pilot 600 from GE Healthcare is a lightweight bench-top chromatography system suited to streamline both GMP and non-GMP everyday operations.
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