Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.
- Forum Notebook: Quick Takes From USP’s mRNA Virtual Summit
- Assessing pDNA Purity For Cell & Gene Therapies
- SUS, PAT, And Other Tech Advancing Upstream Bioprocessing
- Integrating Quality Processes And Documentation After A Merger
- NK Cell Therapies: How Artiva Biotherapeutics Leverages Its “Manufacturing First” Approach
- 7 Bioprocess Intensification Strategies
- Improving Governance And Compliance With Knowledge Management
EDITOR'S DESK
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Eying Up The Era Of Topical Biologics
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.
The U.S. imported $6.95 billion worth of pharmaceuticals from China in 2022. That was 8x the amount we imported in 2021. A proposed Act of Congress puts that supply, and U.S. biotech itself, in serious peril.
GUEST COLUMNISTS
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Forum Notebook: Quick Takes From USP’s mRNA Virtual Summit
The United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.
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Assessing pDNA Purity For Cell & Gene Therapies
Plasmid DNA (pDNA) is used in gene therapies, vaccines, and RNA therapeutics. Along each step of development, we need to evaluate potential impurities.
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SUS, PAT, And Other Tech Advancing Upstream Bioprocessing
As the sector grows, technology and techniques are becoming more sophisticated, including single-use systems, automation, and bioreactors.
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Integrating Quality Processes And Documentation After A Merger
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
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NK Cell Therapies: How Artiva Biotherapeutics Leverages Its “Manufacturing First” Approach
We caught up with Chris Horan, Artiva Biotherapeutics' CTO, to discuss natural killer cell therapies and Artiva’s experiences and strategies with its candidate, AlloNK.
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Improving Governance And Compliance With Knowledge Management
Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.
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GMP Plant Uniform Lockers And Procedures: Best Practices
As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.
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A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers
Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.
BIOPROCESSING WHITE PAPERS
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Frontiers In Digital Bioprocessing: Modular Plant Automation And Cloud
As the biopharmaceutical industry is embracing digital transformation and thus evolves in its digital maturity, future-ready concepts will play a leading role in the shift toward bioprocessing 4.0.
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Extractables And Leachables Testing4/9/2024
Learn how to navigate the extractables and leachables regulatory landscape and implement best practices for leachables analysis in your pharmaceutical development process.
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies2/24/2023
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
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Successful Planning: Process Liquid & Buffer Preparation6/23/2023
Obtain an accurate total cost of ownership assessment through understanding common operational inefficiencies, risks, and financial burdens associated with process liquid and buffer preparation.
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Sterile Filtration And Quality Risk Management8/31/2023
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
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Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products2/15/2023
Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
BIOPROCESSING APP NOTES & CASE STUDIES
- High Sequence Coverage And Confident PTM Analysis Of Biotherapeutics Using An EAD-Based Workflow
- Enhancing Ease Of Use Batch Turnaround And Process Flexibility With Single-Use TFF
- What Provided Critical Reagents To The COVID-19 Pandemic Response?
- Evaluating The Corning® CellCube® System
- Rare Cell Isolation
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
- Pharmaceutical Characterization With Multi-Sample DSC Technology
- Advances In Applied Nanotechnology For Formulating Better ASDs And mAbs
- Innovative Analytical Strategies To Address Common Development Challenges
- Producing Therapeutic Cardiomyocytes From iPSC Stem Cells
- Risk Control | Bulk Filling Application
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 05.06.24 -- Solutions For Your Fermentation Projects
- 05.06.24 -- Cell Counting Is Growing More Important Amid Advanced Therapy's Rise
- 05.03.24 -- Cell Culture Media: Partners Poised To Meet Demand
- 05.03.24 -- NK Cell Therapies: How Artiva Biotherapeutics Leverages Its "Manufacturing First" Approach
- 05.02.24 -- Pioneering Optimal Cell And Gene Therapy Performance