Coya Therapeutic’ executive chairman, Howard Berman, Ph.D., discusses the company's approach to developing a combination biologic and the challenges that multi-targeted therapeutics present.
- 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
- Cell & Gene Therapies: Avoid This Common Pitfall In Supply Chain Planning
- Exploring Sanofi R&D's Batch Monitoring Initiative
EDITOR'S DESK
-
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
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
Data Quality Issues At The Heart Of FDA's DSCSA Troubles
Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.
-
A "Particular" Problem For Cell Therapy Products, Part 2: Cell Clumps And Other Inherent Particles
Cell clumps may be present prior to administration of your final drug product. In the absence of regulatory guidance, we recommend establishing a risk management strategy for control of particulates.
BIOPROCESSING WHITE PAPERS
-
Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process
Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
-
Benefits Of PCR-Based mRNA Manufacturing Processes5/17/2024
Learn about a proprietary polymerase chain reaction (PCR) solution that was developed to overcome the challenges associated with pDNA that applies the high accuracy of PCR to mRNA manufacturing.
-
Assessing Liquid Transfer Performance With Reliable, Ready-To-Use Reagents11/13/2023
See how specially formulated dye-containing solutions replicate the liquid transfer properties of several commercially available PCR master mixes, making them reliable and ready-to-use reagents for determining liquid transfer performance.
-
Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing4/24/2024
Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.
-
Comparing Single-Use To Fixed Bioprocessing Systems9/1/2023
Several life cycle assessments have been conducted comparing the environmental impact of SUTs to conventional fixed systems, leading to results that could inform changes in bioprocess system use.
-
Finding An Optimal Harvest Solution By Considering Both Cost And Sustainability7/10/2024
Choosing the right harvest solution is pivotal in the pursuit of efficient and sustainable bioproduction. Let's explore the cost and sustainability benefits of a single-use centrifuge over traditional depth filtration methods.
BIOPROCESSING APP NOTES & CASE STUDIES
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
ON-DEMAND WEBINARS
- Robust Process Solutions To Purify GLP-1 Receptor Agonists
- Regulatory Considerations When Choosing Stem Cell Media
- Multi-Tiered Classification For Downstream Process Intensification
- The Impact Of Pipetting Technique On Cell Line Development Workflows
- Regulatory Considerations Including Extractables & Leachables For Single-Use Manufacturing
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 11.01.24 -- Accelerating And Enhancing ADC Therapies
- 11.01.24 -- The Influence Of Flows In cGMP Architectural Design
- 10.31.24 -- CDER Wants Your Input On Improving Integrated Reviews
- 10.30.24 -- Driving Therapeutic Innovation With Bioconjugates
- 10.30.24 -- Navigate Regulatory Landscapes In Your mRNA Drug Development