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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PEG In LNP Formulations: Addressing Challenges And Seeking Solutions
Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks. Explore those concerns, here.
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Assurance Of Clonality For Biotherapeutics10/13/2022
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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Designing An Environmental Monitoring Solution For cGMP Manufacturing3/13/2023
Environmental monitoring in cleanrooms should be performed using suitable techniques that meet the needs of the risk assessment. Learn about the requirements, typical instrumentation features, and more.
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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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Trends In Precision Medicine: Cancer10/24/2023
Scientists are working to discover new and effective ways precision medicine can prevent, diagnose, and treat diseases such as cancer.
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Match Your Development And Manufacturing Path To Your IND Milestones2/17/2023
The drug development journey is long, expensive, resource straining, and risky. Discover how to maximize the value of early phase material and match your development path to your IND milestones.
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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NEWSLETTER ARCHIVE
- 05.08.24 -- Find Filtration Products For Your Specific Applications
- 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