Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.
- Outsourced Complex Protein Development Demands Special Considerations
- Accelerate CMC Development With Team Topologies
- Upping Flow Of Advanced Technologies Into Commercial Biomanufacturing
- FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals
- The Peril Of Analytical Methods Transfer
- Wish SUS Cost Less? Survey Says Your Peers Do, Too
- A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions
GUEST COLUMNISTS
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Accelerate CMC Development With Team Topologies
A method of defining role boundaries for knowledge workers in the IT industry maps nicely to CMC process development for biologics and pharmaceutical manufacturing.
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Upping Flow Of Advanced Technologies Into Commercial Biomanufacturing
A set of tools NASA developed assessing new, rapidly developed and deployed technology could help biopharmas adopt advanced tech post-commercialization.
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FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals
The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.
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Wish SUS Cost Less? Survey Says Your Peers Do, Too
BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.
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A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions
Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.
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Drug Product Formulation & Process Development: The Must-Have Skills At A Glance
Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.
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Tips For Deploying Advanced Modeling In Commercial Phase Bioprocessing
In-silico tools are ubiquitous in development, but big hurdles prevent them from showing up meaningfully in commercial manufacturing. These tips could help clear them.
BIOSIMILAR WHITE PAPERS
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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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Business Continuity Management: The Benzonase® Endonuclease Success Story8/21/2024
Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
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Validation Master Plan For Filtration Systems Used In Aseptic Processing1/13/2023
Regulatory guidance provides a framework for aseptic processing that ensures patient safety. Learn about the best practices for validating performance of critical filtration systems used in aseptic processing.
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Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization8/25/2023
There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.
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The Role Of Extractables Data In The Adoption Of Single-Use Systems8/29/2024
Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.
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COGs Process Economics For Autologous Cell Therapy8/11/2023
Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and additional insights. Discover how cell therapy manufacturers can combat these costs.
BIOSIMILAR APP NOTES & CASE STUDIES
- Impact Of DMSO And Freezing Technique In Upstream Bioprocessing
- Bulk Filling Of Drug Substance | Accurate Aliquoting
- Developing A Large-Scale Tangential Flow Filtration Process
- Using High Cell Density Cryopreservation For Seed Train Intensification
- Fab Fragment Development And Manufacturing For Clinical Trials
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.
More Content CollectionsBIOSIMILAR DEVELOPMENT NEWS
- Teva And mAbxience Expand Strategic Partnership To Include An Additional Oncology Biosimilar Candidate
- Blue Shield Of California Slashes Cost Of World's Best-Selling Drug
- Evio Announces Groundbreaking Direct Purchase Agreement For Adalimumab Biosimilar
- Fresenius Kabi And Formycon Receive U.S. FDA Approval For Biosimilar Otulfi* (ustekinumab-aauz)
- AEON Biopharma Announces Positive Outcome From FDA Biosimilar Advisory Meeting
- Primary Endpoint Met In Phase 3 Comparative Clinical Study Of Perjeta (pertuzumab) Biosimilar Candidate HLX11
- Otulfi*, Fresenius Kabi's Ustekinumab Biosimilar Developed By Formycon, Receives European Commission Approval
- Xbrane Provides Update From Scientific Advice With US FDA On Xdivane (Opdivo Biosimilar Candidate)
NEWSLETTER ARCHIVE
- 10.03.24 -- The Peril Of Analytical Method Transfer
- 10.02.24 -- Dig Into Ideas, Data, And Examples Of Bioprocessing Intensification Strategies
- 10.01.24 -- Unlocking Biomanufacturing Success: Partnerships, Immunogenicity, And Tech
- 09.26.24 -- 3 Must-Have Skills For Drug Product Formulation & Process Development
- 09.19.24 -- Advancing Drug Delivery: Safety, Reliability, And Innovation