Complexity and manufacturability have an inverse relationship. Ring’s platform seeks to simplify highly complex gene therapy production by making the most of biology.
- Maintaining Harmony With Your CDMO Using 'The Middle Way'
- Inside J&J's Many-Indication mAb
- How Cidara Got Its Molecule Back
- A Comprehensive Guide For Supplier Quality Agreements
- Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards
- Safety Cabinets' Essential Role In EU GMP Annex 1
- Life Sciences Cybersecurity Incident Management: The End-to-End Approach
EDITOR'S DESK
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Suppliers Pushing Novel Analytical Methods Testing Forward
The urgency to develop novel therapeutics must be balanced by rigorous safety testing, but cell and gene therapy testing protocols, of which there are many, have to date been neither standard nor quick. What role are outsourced testing service providers playing to change that paradigm?
Heidi Zhang, Ph.D., explains Tune Therapeutics' epigenetic approach to gene therapy and how the company is preparing its lead candidate for the clinic, as well as it's modular approach to automation.
Susan Sharfstein, Ph.D., explains how discovery-driven research can further our understanding of cellular biology and ultimately inform cell line development.
Leading experts in gene therapy discuss CMC strategy for platform technologies, product lifecycle management, and the role CDMOs play in moving the space forward.
At the 2024 Bioprocessing Summit, a panel of CMC experts spoke about the challenges commercializing gene therapies, specifically focusing on considerations for late-stage process changes.
GUEST COLUMNISTS
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A Comprehensive Guide For Supplier Quality Agreements
This overview of SQAs includes a handy matrix template, which is useful for determining who is responsible for managing specific responsibilities.
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Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies
In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.
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Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards
A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.
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Safety Cabinets' Essential Role In EU GMP Annex 1
A new chapter by GMP Compliance Adviser explores safety cabinet classifications and applications, plus requirements for their construction and and installation, per Annex 1.
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Life Sciences Cybersecurity Incident Management: The End-to-End Approach
Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.
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Cell & Gene Therapies: Avoid This Common Pitfall In Supply Chain Planning
BioPhorum members propose a Design for Supply model for cell and gene therapy supply chain planning. Don't let it take a backseat until the later stages of the product life cycle.
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Exploring Sanofi R&D's Batch Monitoring Initiative
The project established predictability during testing and release for the production of medicine to support clinical trials.
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What's Next After FDA's DSCSA Extension?
Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.
BIOPROCESSING WHITE PAPERS
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Using SerumSub™ QualAssure™ To Assess Liquid Transfer Performance
In this study, SerumSub™ QualAssure™, a serum-like reference solution with liquid handling properties that are analogous to several commonly used sera, is compared to various commercially available mammalian sera.
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars2/9/2024
The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
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Is Mannitol Hemihydrate Detrimental To Protein Stability?10/16/2024
Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
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Process Development For Lyophilized Products10/16/2024
Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.
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Vial Fogging: Practical Considerations For Vial Selection10/16/2024
Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.
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The Current And Future Value Of mRNA Vaccines And Therapeutics5/16/2024
Discover how decades of research have propelled mRNA technology to the forefront of therapeutic development and learn how our expertise is advancing mRNA drug development.
BIOPROCESSING APP NOTES & CASE STUDIES
- What Changes When Your CPV Goes Digital
- Evaluating The Expression Patterns Of Multiple Inhibitory Receptors Associated With T-Cell Exhaustion Using Multicolor Flow Cytometry
- A Better Immune Response To Vaccination: Using Lymphoid Follicle Organ-Chips
- A Solution For The Scale-Up Of Multi-Column Chromatography
- AAV Full/Empty Capsid Separation Using Mechanistic Modeling
BIOPROCESS ONLINE CONTENT COLLECTIONS
This collection of articles, produced through a partnership between MilliporeSigma and Bioprocess Online, highlights the need for ongoing investment in resilient biomanufacturing capacity and supply chains to ensure the reliable delivery of health technologies like vaccines, even during crisis conditions.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
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NEWSLETTER ARCHIVE
- 11.05.24 -- Take The Next Step Towards Scaling-Up
- 11.05.24 -- Make It Homogenous With Closed Recirculating Systems
- 11.05.24 -- Comparing In-house Vs. Outsourced Manufacturing Strategies For CGTs
- 11.04.24 -- Achieve Painless Precision With An Automation Software Platform
- 11.04.24 -- Achieving Quality, Safety, And Sustainability In Pharmaceutical Manufacturing