Here's an overview of advancements in technology and industry built around biopharmaceutical supply chain and logistics, including packaging and temperature controls.
- Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods
- 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
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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New Initiative Seeks To Back Up ICH's Harmonization Mission
An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.
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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.
BIOPROCESSING WHITE PAPERS
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Assessing Liquid Transfer Performance With Reliable, Ready-To-Use Reagents
See how specially formulated dye-containing solutions replicate the liquid transfer properties of several commercially available PCR master mixes, making them reliable and ready-to-use reagents for determining liquid transfer performance.
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Understanding Viral Clearance During Anion-Exchange Chromatography3/26/2024
A design of experiments (DoE) study examined the anion-exchange process in general and to draw possible correlations between such properties and overall viral clearance capability.
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Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs8/14/2023
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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Using Next Generation Sequencing Methods For Virus Vector Identity Testing9/7/2022
Sequencing techniques play a crucial role in establishing the quality attributes of a variety of therapeutic products. Learn what advantages NGS offers for obtaining accurate sequences.
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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?
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Development And Optimization Of Suspension-Adapted 293T Cell Line3/21/2024
Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.
BIOPROCESSING APP NOTES & CASE STUDIES
- AAV Full/Empty Capsid Separation Using Mechanistic Modeling
- Comparison To And Advantages Over Traditional Chemometrics Models
- Find The Right T Cell Expansion And Phenotype Balance For Cell Therapy
- In Vitro Glycoengineering – Suitability For BioPharma Manufacturing
- Transition To Closed Processing Systems For Cell Expansion And Banking
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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ON-DEMAND WEBINARS
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- Producing Therapeutic Cardiomyocytes From iPSC Stem Cells
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