BioPharm International-04-01-2020

New bioreactor designs, coupled with better media, process intensification and analytics, continue to improve upstream bioprocessing.

Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

As politicians focus on drug cost reduction, biopharmaceutical companies in the US are moving to states with lower taxes and relocating some facilities that had been offshore.

The latest advances in downstream technologies include a fluid chromatography system, sensing and control units for hygienic valves, a compact valve platform, a membrane purification column, and a protein A affinity chromatography resin.

General Purpose Pro Centrifuge Series centrifuges by Thermo Fisher Scientific are designed to deliver a regulatory-compliant benchtop separation solution to meet the application needs of scientists working in biopharmaceuticals, academic research, and clinical diagnostic applications.

Shim-pack Bio Diol and IEX columns from Shimadzu Scientific Instruments improve the accuracy of the characterization of peptides, oligonucleotides, and other biopharmaceuticals.

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

Demonstrating interchangeability can ensure biosimilar substitutability at the pharmacy level.

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

More sustainable and functional packaging protects temperature-sensitive drugs.

FDA is encouraging alternative insulins and challenging anticompetitive practices.

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Single-use solutions continue to grow in popularity, largely as a result of the cost and time efficiencies they can afford biopharma companies.

As a result of the rising use and development of biological drugs, the biopharma industry is witnessing an increase in the adoption of prefilled syringes.

Pharmaceutical Technology spoke with Jens Andersson, purchasing director at Cambrex Karlskoga, about the best way to ensure the security of the bio/pharmaceutical materials supply chain.

Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.

As the coronavirus pandemic unfolds, the bio/pharma industry must practice science over hype.