Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
|Articles|July 2, 2016
- Pharmaceutical Technology-07-02-2016
- Volume 40
- Issue 7
Single-Use Bioreactor Reduces Turnaround Time
The BIOne single-use bioreactor from Distek is a benchtop scale single-use bioreactor (SUB) system for mammalian cell growth and recombinant protein production.
The BIOne single-use bioreactor from Distek is a benchtop scale single-use bioreactor (SUB) system for mammalian cell growth and recombinant protein production. The pre-sterilized BIOne system is engineered with a disposable headplate welded to a tri-layer liner that can be easily inserted into a non-sterile bioreactor glass vessel, converting it to a sterile, disposable SUB. All materials are USP Class VI, animal derivative free, and used in existing single-use products. The system reduces turnaround time by allowing users to transition to a disposable platform while using existing equipment, without compromising the scalability of current processes.
Articles in this issue
about 10 years ago
FDA and Manufacturers Intensify Concerns about Data Integrityabout 10 years ago
Planning a Biologics Facility Start Upabout 10 years ago
Solid-Dosage Packaging Trendsabout 10 years ago
Quality System for a Regulatory Affairs Departmentabout 10 years ago
Data Integrity Challenges in Manufacturingabout 10 years ago
Bio/Pharma Funding Challenges Could Hurt CDMOs in 2017about 10 years ago
Cleaning Bioreactors and Fermenters with CIP Systemsabout 10 years ago
Maximize Efficiency in Tooling Maintenanceabout 10 years ago
Recognizing Pharma Industry Excellenceabout 10 years ago
Expanding the Chiral ToolboxRelated to this article
This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
Florin Muraru, Gourav Pandey, and Richard Jaenisch explain where human sign-off belongs as multi-agent AI and document-parsing models reach GxP.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
The EC has approved AstraZeneca's Trixeo Aerosphere as the first single-inhaler triple-combination therapy for asthma in the EU, based on phase e data showing improved lung function and fewer severe exacerbations in patients uncontrolled on standard ICS/LABA treatment.
In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.
Trending on Pharmaceutical Technology
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The FDA Finalizes Rule Recognizing Non-Animal Testing Methods, Building on Year-Long Reduction Push
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EU Clears AstraZeneca's Trixeo for Asthma, Opening New Manufacturing Demand for Single-Inhaler Triple Therapy
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Weekly Basal Insulin Efsitora: A New Biologics CMC Benchmark
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Pharma Fundamentals: Digital Pathology in Drug Development, Part 1
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