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BioPharm International-06-01-2018
BioPharm International
Outsourcing Analytical Methods
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.
Rapid Adventitious Agent Testing Remains a Real Need
June 01, 2018
Features
31
6
More advanced NGS-based techniques still require validation and regulatory acceptance.
Understanding Validation and Technical Transfer, Part 3
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.
Manufacturers Under Pressure to Curb Opioid Use and Abuse
June 01, 2018
Regulatory Beat
31
6
FDA and Congress seek to limit the production and distribution of pain medicines.
CMOs Expand Manufacturing Capacities
June 01, 2018
Perspectives on Outsourcing
31
6
New and expanded facilities point to the continuing growth of the biopharmaceutical industry.
Bioreactor Monitoring: More to Measure than Glucose In, mAb Out
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
Tablet for Field Instrument Management
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.
Bench-Top Chromatography System
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.
Automation Trend in Fill/Finish Reduces Contamination Risk
June 01, 2018
Cover Story
31
6
Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.
Challenges in Cell Harvesting Prompt Enhancements
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.
Meeting the Challenge of Patient-Centered Clinical Trials
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.
Let the Learning Commence
June 01, 2018
From the Editor
31
6
By minding gaps in industry knowledge, bio/pharma companies can avoid development pitfalls.
Transcriptomics and the Production of Recombinant Therapeutics
June 01, 2018
Features
31
6
Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.
BioPharm International, June 2018 Issue (PDF)
June 01, 2018
Issue PDF
31
6
Click the title above to open the BioPharm International June 2018 issue in an interactive PDF format.