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.
- Improving Governance And Compliance With Knowledge Management
- GMP Plant Uniform Lockers And Procedures: Best Practices
- A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers
- Developing A Process Performance Qualification Master Plan For Gene Therapies
- What Time Is Best To Bring My CDMO On Board?
- Single Use In Biopharma: Beyond Savings & Sustainability
- Unpacking The Importance Of Lipid Nanoparticle Production Platforms
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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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.
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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.
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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.
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What Time Is Best To Bring My CDMO On Board?
The answer might be sooner than you think and entail more transparency than you're used to.
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Unpacking The Importance Of Lipid Nanoparticle Production Platforms
Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.
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Cell Counting Is Growing More Important Amid Advanced Therapy’s Rise
You can't improve what you don't measure. This discussion explores advances in cell counting technology and the growing number of ways it aids the biotech industry and beyond.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
BIOPROCESSING WHITE PAPERS
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Selecting Optimal Chromatography Resins To Support mAb Purification
Discover key considerations when selecting resin options for mAb purification, including alternatives to the conventional affinity capture step.
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Clear MRSA Infections At Single Low Doses1/4/2024
Multidrug-resistant bacteria are rendering antibiotics ineffective. Review preclinical results of a potent macrocycle derivative and why collaboration is crucial to transition discoveries into treatments.
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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.
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Response To FDA Black Box Warning3/1/2024
The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.
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Inspection Of Injectable Products For Visible Particulates8/8/2023
Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
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Streamlining And Standardizing Cell And Gene Therapies From Process To Product1/13/2023
Cell and gene therapies are transforming the lives of patients with various rare genetic diseases and more common conditions such as cancer. However, the rapid pace of scientific progress has overwhelmed supply infrastructure, creating pressures to scale manufacturing, increase capacity and meet a wide range of deliverable requirements.
BIOPROCESSING APP NOTES & CASE STUDIES
- Optimizing Human iPSC Aggregate And Organoid Production For Bioprinting
- Optimized Performance Model For Yield And Quality Of The mRNA Product
- Understanding The Microfluidic Platforms For Scaling Nanoparticle Production
- Next-Generation Single-Use Harvest Solutions
- Lipid Nanoparticle Compositional Analysis By UHPLC-CAD
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
- 04.25.24 -- Digitizing CMC Knowledge Management
- 04.24.24 -- Biopharma Equipment Sourcing Strategies To Reduce Costs And Risks
- 04.24.24 -- Improve Your Process Development To Accommodate Diverse mAbs
- 04.23.24 -- Genetic Stability Simplified. One Method, Multiple Answers.
- 04.23.24 -- Business Of Biotech Newsletter