The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
- New Initiative Seeks To Back Up ICH's Harmonization Mission
- 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
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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Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods
Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.
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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.
BIOPROCESSING WHITE PAPERS
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Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing
For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.
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Using SerumSub™ QualAssure™ To Assess Liquid Transfer Performance11/13/2023
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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Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass5/12/2023
Explore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos® 168.
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Manufacturing Challenges With High Concentration Biologics3/18/2024
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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Cost Effective And Sustainable Harvest Solutions3/21/2023
Learn about a single-use centrifuge that is emerging as an exceptional technology as it is a more sustainable harvest solution and creates cost savings.
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7 Tips To Improve OT Cybersecurity For Life Sciences11/22/2023
Leverage the insights of cybersecurity specialists and industry experts to gain a broader context for more informed decision-making regarding actions and next steps to improve OT cybersecurity.
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.
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- Innovative Analytical Strategies To Address Common Development Challenges
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NEWSLETTER ARCHIVE
- 05.08.24 -- Assessing pDNA Purity For Cell & Gene Therapies
- 05.07.24 -- Learn How To Reduce Translational Failure Through Next Generation Organ-on-a-Chip Technology
- 05.07.24 -- Let's deviate from deviations - Sterile drugs.
- 05.07.24 -- Unpacking The Importance Of Lipid Nanoparticle Production Platforms
- 05.06.24 -- Solutions For Your Fermentation Projects