Pharmaceutical Technology-11-02-2020

As biopharmaceutical process development advances, a more collaborative and knowledge-based approach, driven by better analytics and high-throughput system integration, is reducing the risk of failure.

This paper reviews considerations for the formulation of chewable tablets including sensory characteristics, chewability assessment, and drug release.

Biological and analytical advances enable modern fermentation processes to deliver safe and effective next-generation medicines.

Amorphous solid dispersions are a useful tool in overcoming solubility issues, but they have not yet reached full potential in commercial success.

An optimal engineering design is crucial for aseptic operation and cleaning.

Successful migrations require careful planning to meet business needs and maintain data integrity.

Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.

Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.

Assessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories.

Consider modular automation and cybersecurity when modernizing manufacturing processes.

Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.

The agency is balancing a variety of important issues including the review of COVID-19 vaccines.

Industry wants clarification on compliance following the end of the Brexit transition period.

Resolving drug shortages starts with identifying the source of the problem.

Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.

TurboFil Packaging Machines introduced the SimpliFil Syringe Filling & Assembly System for the automated production of syringe formats.

The ROSS Double Planetary Mixer from Charles Ross & Son Company is available with an optional weighing system for precise measurements throughout the batching procedure.

The HFC Disconnect Series from CPC (Colder Products Company) provides sterile disconnection of tubing used for single-use biopharma and cell and gene therapy manufacturing systems.

The new line of Defined Tubing Routing (DTR) from High Purity New England is a flexible tubing support system for single-use biopharmaceutical manufacturing.