BioPharm International
June 01, 2018
Ask the Expert
31
6
Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
June 01, 2018
Features
31
6
More advanced NGS-based techniques still require validation and regulatory acceptance.
June 01, 2018
Features
31
6
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
June 01, 2018
Regulatory Beat
31
6
FDA and Congress seek to limit the production and distribution of pain medicines.
June 01, 2018
Perspectives on Outsourcing
31
6
New and expanded facilities point to the continuing growth of the biopharmaceutical industry.
June 01, 2018
Features
31
6
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
June 01, 2018
Product Spotlight
31
6
Endress+Hauser’s Field Xpert SMT70 is a tablet PC suited for commissioning and maintaining field instruments in hazardous and non-hazardous locations.
June 01, 2018
Product Spotlight
31
6
The ÄKTA pilot 600 from GE Healthcare is a lightweight bench-top chromatography system suited to streamline both GMP and non-GMP everyday operations.
June 01, 2018
Cover Story
31
6
Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.
June 01, 2018
Features
31
6
Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.
June 01, 2018
Features
31
6
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.
June 01, 2018
From the Editor
31
6
By minding gaps in industry knowledge, bio/pharma companies can avoid development pitfalls.
June 01, 2018
Features
31
6
Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.
June 01, 2018
Issue PDF
31
6
Click the title above to open the BioPharm International June 2018 issue in an interactive PDF format.