Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.
- 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
- GMP Plant Uniform Lockers And Procedures: Best Practices
EDITOR'S DESK
-
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
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
Developing A Process Performance Qualification Master Plan For Gene Therapies
This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.
BIOPROCESSING WHITE PAPERS
-
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.
-
How Can DOE Help Optimize Your Purification Workflow?6/9/2023
Improve your downstream purification process and utilize design of experiments (DOE) to help in selecting appropriate chromatographic techniques and account for variation among mAbs.
-
Revolutionizing Particle Characterization With Image Analysis And ML9/27/2023
The biopharmaceutical industry is increasingly employing micro-flow imaging for particle characterization, owing to the superior insights it can afford into product quality and process controls.
-
A Molecule’s Journey: Break Down Roadblocks To Clinical Success7/13/2023
The key to a biopharma executive's success is making the right decisions at the right time. Which will get your biologic to the clinic quickly and cost-effectively, without compromising quality and patient safety?
-
Bench To Bedside: A Scalable End-To-End Solution For AAV Production8/30/2022
How to efficiently translate bench-scale processes to commercial GMP manufacturing to produce viral vectors at the scale needed to meet dosage requirements.
-
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.
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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- 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
- AAV Analytics: Key Considerations When Developing A Clinical Program
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 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
- 05.02.24 -- Listen now: Precision Drug Delivery, Clinical Trial Progress for Parkinson's, Funding Alzheimer's Tx, and more.
- 05.02.24 -- Software Validation Keeps GxP Systems Current, Speeds Up Time-To-Market