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BioPharm International, August 2021 Issue
Single-Use Technologies Prove Effective for Viral Vector Process Development
August 02, 2021
Cover Story
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8
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Subunit Vaccines and the Fight Against COVID-19
August 02, 2021
Development
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8
Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.
Using Picodroplet Technology to Optimize Bispecific Cell Lines
August 02, 2021
Development
34
8
Growing demand for bispecific antibodies increases the need for automated and miniaturized high throughput screening capabilities.
Cell Harvesting Sees Benefits from Automated Processes
August 01, 2021
Downstream Processing
34
8
Automation is one asset that benefits cell harvesting by cutting out laborious manual steps and minimizing contamination.
The Evolving Aseptic Processing Landscape
August 01, 2021
Manufacturing
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Through the adoption of single-use technology, drug manufacturers have been able to adapt to the challenges posed by the COVID-19 pandemic.
Designing Flexible Fill/Finish Facilities
August 01, 2021
Manufacturing
34
8
Scenario modeling informs planning for current and future manufacturing needs.
Statistical Approaches for Determining Comparability of Biosimilars
August 01, 2021
Analytics
34
8
Correct organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.
Packaging for Stability Studies: to Outsource or Not?
August 01, 2021
Outsourcing
34
8
Manufacturers should consider the benefits and risks of contract packaging for stability studies.
FDA Prioritizes Vaccine Review and Process Improvements
August 01, 2021
Regulatory Beat
34
8
Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.
FDA Inspections Back on Track?
August 01, 2021
From the Editor
34
8
Congress questions FDA on plans to catch up and move forward with facility inspections as pandemic travel restrictions ease.
GMPs for Emerging Therapies
August 01, 2021
Ask The Expert
34
8
Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, provide answers to frequently asked regulatory questions about advanced therapy medicinal products.
Syringe Inspection Line
August 01, 2021
Product Spotlight
34
8
Syntegon's Syringe Inspection Line utilizes an AI vision system for the inspection of syringe flanges, stoppers, and cylinders.
Automated Incubator System
August 01, 2021
Product Spotlight
34
8
The Cytomat 24 automated incubator system is designed for large-capacity microplate processing.
Freeze Dryer Loaders
August 01, 2021
Product Spotlight
34
8
SP Scientific's SALS30 and RxR-36 are designed for fill/finish processing applications like freeze dryers.
Eco-Friendly Freezers
August 01, 2021
Product Spotlight
34
8
Eppendorf's CryoCubeF440 freezer has been redesigned to promote sustainability through various green features.