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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Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility
The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
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Risk Assessment As A Process Quality Assurance Tool8/12/2022
Discover how an effective approach to risk management can further ensure the delivery of a high-quality drug or medicine to the patient.
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β-Glucan As A Process-Related Impurity In Biopharmaceuticals5/17/2022
In this white paper, we dig deeper into the sources of β-glucan, its influence on manufacturing and patient safety, and ways to detect and control its amounts in the finished drug product.
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How Close Are We To The Clinic?3/27/2024
Organoids are offering new possibilities in therapeutic screening, regenerative medicine, and even organ transplantations. However, there are still several challenges to overcome.
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Is Mannitol Hemihydrate Detrimental To Protein Stability?12/8/2023
Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
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Selecting Optimal Chromatography Resins To Support mAb Purification10/2/2023
Discover key considerations when selecting resin options for mAb purification, including alternatives to the conventional affinity capture step.
BIOPROCESSING APP NOTES & CASE STUDIES
- Streamlining The Integrity Testing Process – From Test To Report
- Enhancing Lentiviral And AAV Transduction Of T Cells
- Capture Of Bispecific Antibodies And Removal Of Product-Related Impurities
- High Yield Protein Production System For Suspension CHO Cells
- Ultrafiltration/Diafiltration In The Antibody Drug Conjugate Manufacturing Process
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
- 04.26.24 -- Strategies For Minimizing The Impact Of Bioburden And Sterility Testing On Gene Therapy Batch Yield
- 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.