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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Match Your Development And Manufacturing Path To Your IND Milestones
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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A Risk-Based Approach To Injectable Combination Product Development3/14/2023
Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
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Expand Your Toolbox For Quality mRNA Manufacturing4/9/2024
Explore guidelines for the use of SP6 RNA Polymerase in mRNA synthesis and your mRNA production processes.
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From Bench To Billions: Facilitating Scale-Up Of Adherent Cultures For Cell And Gene Therapies6/27/2022
We review what researchers should consider when they are creating a risk-mitigating adherent culture process for cell and gene therapy scale-up.
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How Can The Industry Drive Down The Cost Of Viral Gene Therapies?4/5/2023
This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.
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Perspectives On The Adoption Of Fully Closed Processing1/16/2024
In this study, industry experts share their perspectives and plans related to the implementation of fully closed processing. Explore the drivers and challenges of fully closed processing and more.
BIOPROCESSING APP NOTES & CASE STUDIES
- Automating And Optimizing The Cell Harvesting Process
- How Membrane Prefilters Enhance Bioprocessing Efficiency
- Combining Single-Cell Isolation And Microplate Imaging To Improve Cloning Efficiency
- A Guide To Adherent Scale-Up
- Molecular Weight Confirmation For Length, Integrity And Impurity Analysis Of A 70-Mer Oligonucleotide
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
- 05.07.24 -- 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
- 05.06.24 -- Cell Counting Is Growing More Important Amid Advanced Therapy's Rise