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Pharmaceutical Technology-11-02-2020
Pharmaceutical Technology
Bringing Bioprocess Development into Focus
November 03, 2020
Cover Story
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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.
Chewable Tablets: A Review of Formulation Considerations
November 03, 2020
Peer-Review Research
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This paper reviews considerations for the formulation of chewable tablets including sensory characteristics, chewability assessment, and drug release.
Fermentation Finds Fans in Small-Molecule API Synthesis
November 03, 2020
Development
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Biological and analytical advances enable modern fermentation processes to deliver safe and effective next-generation medicines.
Improving Solubility with Amorphous Solid Dispersions
November 03, 2020
Development
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Amorphous solid dispersions are a useful tool in overcoming solubility issues, but they have not yet reached full potential in commercial success.
Understanding the Impact of Annex 1 on Isolator Design
November 03, 2020
Manufacturing
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An optimal engineering design is crucial for aseptic operation and cleaning.
How To Execute Successful Data Migrations
November 03, 2020
Manufacturing
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Successful migrations require careful planning to meet business needs and maintain data integrity.
Dealing with No Deal
November 03, 2020
Quality
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Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.
GMPs Guide COVID-19 Vaccine Manufacturing
November 03, 2020
Quality/Regulations
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Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.
Understanding the Critical Role of Integrity Testing in Laboratory Sterility Filtration
November 02, 2020
Analytics
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Assessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories.
Adopting Digitalization in Biopharma Facilities
November 02, 2020
Operations
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Consider modular automation and cybersecurity when modernizing manufacturing processes.
COVID-19 Vaccine Distribution Raises Multiple Challenges
November 02, 2020
Regulatory Watch
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Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.
COVID-19 Stresses EMA Resources
November 02, 2020
Regulatory Watch
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The agency is balancing a variety of important issues including the review of COVID-19 vaccines.
Calling for Clarity
November 02, 2020
From The Editor
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Industry wants clarification on compliance following the end of the Brexit transition period.
Pandemic-fighting Drugs in Shortage, Again
November 02, 2020
From The Editor
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Resolving drug shortages starts with identifying the source of the problem.
Resuming Operations During a Pandemic
November 02, 2020
Ask the Expert
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Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.
Syringe Filling and Assembly System
November 02, 2020
Product Spotlight
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TurboFil Packaging Machines introduced the SimpliFil Syringe Filling & Assembly System for the automated production of syringe formats.
Double Planetary Mixer
November 02, 2020
Product Spotlight
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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 for Cell and Gene Therapy Manufacturing
November 02, 2020
Product Spotlight
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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.
Tubing Support System for Single-Use Manufacturing
November 02, 2020
Product Spotlight
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The new line of Defined Tubing Routing (DTR) from High Purity New England is a flexible tubing support system for single-use biopharmaceutical manufacturing.