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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Pharma And Biotech: How Labs Achieve Data Integrity
Learn from an industry expert how important it is for companies to be compliant with data integrity and to ensure the trustworthiness and reliability of electronic records.
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Enabling CDMOs To Focus On Core Priorities4/26/2024
Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.
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Review Of Annex 1 2022: Environmental Monitoring Changes9/13/2022
We highlight the changes to the new revision of the EU GMP Annex 1 regulatory standard for sterile drug products that was released in August 2022.
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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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Strategies For Ensuring Biomanufacturing Resilience For Biologics6/29/2023
Long-term collaboration in resilient biomanufacturing capacity and supply chains ensures the reliable delivery of health technologies. Investigate biomanufacturing resilience strategies for biologics.
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Switching From Vials To PFS And Intravenous To Subcutaneous Formulations7/25/2023
Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.
BIOPROCESSING APP NOTES & CASE STUDIES
- Monoclonal Antibody Aggregate Polish And Viral Clearance Using HIC
- Simple Western Unravels The Signaling Web In Stem Cells For Regenerative Medicine
- Dispensing Fungal Spores
- Touch-Free T Cell Expansion With A Fill-And-Forget Workflow
- Produce A Monoclonal Cell Line Expressing A Clinical Candidate Bi-Specific Antibody In Less Time
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
- 05.08.24 -- 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