The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios.
- Risk Tool Selection With ICH Q9(R1) In Mind
- Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
- Commercial Readiness With Orca Bio's Dan Kirby
- Guidelines For mRNA Drug Product Manufacturing And Quality Control
- Emerging Market Trends For APIs
- Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
- How Strategically Partnering With Academia Supports Biotech R&D Goals
EDITOR'S DESK
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Tech-Heavy Drug Discovery Yields Deep Pipeline
Recursion Cofounder and CEO, Chris Gibson, Ph.D. is creating a map of human biology comparable to Google’s ongoing effort to map every street on the planet. He shared why that's so important, and how it's informing Recursion's rapid drig discovery efforts.
Machines aren’t smart enough to engineer optimal, disease-specific antibodies without data that’s properly generated, captured, and structured. That’s why LabGenius Founder Dr. James Field says the key to success is neither human-derived data, nor machine-enabled design. It’s the organizational engineering feat of bringing the two together.
Early last year, Nutcracker Therapeutics landed a $170 million Series C to further its work developing an RNA drug development platform. Learn how scientist-turned Chief Business Officer Geoff Nosrati is lifting the company above the cacophony of companies rallying around the therapeutic potential of RNA.
Biopharma supply chains and manufacturing capacity are on the comeback trail, but one of the key requirements for sustainable development and manufacturing success remains elusive. NIIMBL Workforce Director John Balchunas shares perspective from a unique vantage point.
Even the best platforms and technologies don’t come out of universities IND-ready. Just ask Coeptis Therapeutics, which recently licensed the novel CAR-T platform, SNAP-CAR, from the University of Pittsburgh. Coeptis’ Dave Mehalick, and Dan Yerace discuss the licensing agreement and the growing pains to expect when preparing a new platform for an IND.
GUEST COLUMNISTS
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Risk Tool Selection With ICH Q9(R1) In Mind
This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.
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Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.
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Guidelines For mRNA Drug Product Manufacturing And Quality Control
The lightning fast rise of mRNA raised the need for manufacturing standards and consensus on product quality attributes and test methods. This article provides perspective and insight on PQAs for mRNA vaccines and other mRNA-based products.
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Emerging Market Trends For APIs
The active pharmaceutical ingredient (API) market is estimated at $158 billion in 2023 and is projected to reach $232 billion by 2028. This article shares new market research on APIs, including an analysis of innovative and generic APIs, synthetic and biotech APIs, and more.
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Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
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How Strategically Partnering With Academia Supports Biotech R&D Goals
For early-stage biotechs, partnering with leading academic institutions can help your firm cut costs and boost the returns on R&D investments while making key research and industry connections that can assist in the development, and ultimate commercialization, of your drug/therapy products.
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Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture
Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern.
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How To Implement Size Exclusion Chromatography And Mitigate HCP Risk
Research shows size-exclusion chromatography improves the host cell protein detection capabilities of liquid chromatography-tandem mass spectrometry. This guest article explores the strategy of using both to better understand HCP persistence in the purification process.
BIOPROCESSING WHITE PAPERS
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Assurance Of Clonality For Biotherapeutics
The clonality of Master Cell Banks (MCBs) for production cell lines is a key requirement in biotherapeutics manufacturing. Learn how new devices help optimize the cloning process.
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Sterile Filtration And Quality Risk Management8/31/2023
During the manufacture of sterile products, process control is essential. Here, we explore the role of filtration for bioburden control in quality risk management and contamination control strategies, EU GMP Annex 1, and more.
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How Controlled Freezing Becomes Reality2/17/2022
Controlling the freezing behavior of bulk drug substance is the ultimate goal in biopharma manufacturing. This study demonstrates the impact of ice front growth speed on scalability of freezing protein solutions.
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Critical Considerations For Buffer Preparation8/7/2023
Learn about the steps of buffer development, supply approach and strategy selection, choosing between in-house and outsourcing buffer activities, and more related to optimizing your organization's buffer use.
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Are End-To-End CDMO Partnerships The Solution To Drug Development And Manufacturing Upheaval?1/24/2022
Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future with uncertainty and disruption.
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Can Yeast Be The Future Of Efficient Subunit Vaccine Manufacturing?9/11/2023
To aid in the manufacturing of new vaccines, Pichia pastoris yeast, a promising protein expression system, could be the perfect solution.
BIOPROCESSING APP NOTES & CASE STUDIES
- Genomic Medicine And The Tools To Realize Its Potential
- AQbD For The Analysis Of Dexamethasone Phosphate And Related Compounds Using Arc Premier MaxPeak High Performance Surfaces (HPS) Technology
- Boost Performance With A Chromatography Resin Update
- Impact Of DMSO And Freezing Technique In Upstream Bioprocessing
- How High-Performance Syringe Filters Extend The Life Of Analytic Instruments And Columns
BIOPROCESS ONLINE CONTENT COLLECTIONS

Biopharmaceutical supply chain strategies can be profoundly bespoke, but best practices like redundancy and quality risk management offer a starting point. The ideas in this collection of recent articles from Bioprocess Online can help shore up your own network in defense of the next upset.
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ON-DEMAND WEBINARS
- Advance Next Gen Biologic Manufacturing
- In-line Monitoring of Bioprocess Parameters for the 21st Century
- Shifting Strategy: Advanced Approaches To Plasmid Production
- From Myth To Mastery: Unveiling The Secrets Of Virus Bank Manufacturing
- A Robust And Scalable Suspension Platform For AAV Manufacturing
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 09.20.23 -- Takeda's Green Approach To IG Purification And Filling
- 09.19.23 -- Enhancing Medicines In Development: A Patient- And Planet-Centric Approach
- 09.19.23 -- Improve Your Productivity With The Use Of Effective Modular Systems
- 09.18.23 -- Key Equipment Sourcing Strategies For Biopharma/Pharma Manufacturers
- 09.18.23 -- Mechanistic Modeling To Optimize rAAV Production For Gene Therapy