Agencies lack a specific definition for deviations, so it’s up to each company to clearly define what they, and then build systems to prevent and react to them.
- EMA Updates Guidance On Inhalation And Nasal Product Quality
- FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
- Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products
- Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?
- Bioprocessing Technology: You Are The Standard
- 7 Steps To Accelerate Biopharma Manufacturing Processes
- A Holistic Approach To Container Closure Integrity
EDITOR'S DESK
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Improving AAV Purity Upstream With PCL Manufacturing
The downstream separation of AAV capsids affects end-product purity and has been identified as a key pain point of the industry. Ultragenyx’s Dennis Huang advises starting with higher-quality yields upstream.
Claris Bio’s phase 1/2 clinical trial in patients with Stage 2 or 3 Neurotrophic Keratitis (NK) is breaking new ground in the development of topically administered biologic therapies.
The biopharmaceutical industry is building manufacturing capacity at breakneck speed. According to PhRMA, there are 1,580-and-counting biopharma manufacturing facilities in the U.S. alone. Problem is, we're way short on filling those facilities with skilled labor. NIIMBL wants to change that. Here's how, and a great opportunity for big pharma, biotech sponsors, CDMOs, academics, and more to help.
The career of Debra Weiss, RN, MSN, and COO at the biopharma Gates Medical Research Institute (Gates MRI), offers a case study in creating success through service-oriented leadership.
Check out the results of DeciBio's Antibody-Drug Conjugates 2024 Industry Survey, which predict another bullish year for the growing modality.
GUEST COLUMNISTS
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EMA Updates Guidance On Inhalation And Nasal Product Quality
The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.
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FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.
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Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products
FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.
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Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?
Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in.
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7 Steps To Accelerate Biopharma Manufacturing Processes
Now more than ever, manufacturing capability can make or break success. To navigate the challenges, small biopharma companies must adopt these strategic approaches.
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A Holistic Approach To Container Closure Integrity
Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.
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Adapting Clinical Supply Strategies Through The Phases
Phase-appropriate logistics are essential to manage resources efficiently, maintain regulatory compliance, and ensure timely delivery.
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How To Unlock Efficiency In MES Integrations
This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.
BIOPROCESSING WHITE PAPERS
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Simplifying The Transition To Multi-Column Chromatography
Explore the advantages of multi-column chromatography and how to transfer your process from batch to an intensified system, step-by-step.
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What's Next For Our Evolving Workforce?6/29/2022
Learn about three industry survival methods that, when applied, can ensure generational workforces are blending cohesively: engagement, culture, and communication.
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The Promise Of PCM: Getting To Maturity9/19/2023
PCM offers a number of advantages, including streamlined development and increased flexibility. Review the key drivers for PCM as well as the hurdles that stand in the way of industry-wide adoption.
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The Dynamic Regulatory Environment Of Drug-Device Combination Products11/29/2022
Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.
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Build Your Genome Engineering Toolbox For Success3/22/2023
Fast, efficient, and precise options for genome engineering are rapidly infiltrating the marketplace – the key to success is identifying the mechanism and tool(s) best suited for your goals.
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Optimizing AAV Purification for High Recovery2/27/2024
How can you improve purification methods for your AAVs and enhance the efficacy and safety of your gene therapy treatments?
BIOPROCESSING APP NOTES & CASE STUDIES
- Optimizing The Formulation For A Monoclonal Antibody
- Workflow Solutions: Choosing The Right ITC Binding Experiment
- Achieve Fast And Efficient Isolation Of Exosomes From Stem Cells
- Generate High Quality Data And Execute Full Factorial Design Of Experiments
- Accurate HC-LC Pairing And A Close-To-Nature Solution For bsAbs
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
- Make Media And Buffers Your Competitive Advantage
- Unleashing The Power Of Perfusion In Intensified Processes
- Optimizing The Path To First-In-Human Clinical Trials: Design And De-Risk
- Key Quality Attributes For mRNA Drug Substance Performance
- How To Bring Your LNP Formulation To Clinical/Commercial Manufacturing
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 05.31.24 -- Justifying New Techniques With Tome Biosciences' Rahul Kakkar, M.D.
- 05.30.24 -- How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing
- 05.30.24 -- Nanoformulation For Improved ASDs, mAbs, & Sustainable Drug Delivery
- 05.30.24 -- 7 Bioprocess Intensification Strategies
- 05.29.24 -- Overcoming Limitations in Antibody-Drug Conjugate Production