A set of tools NASA developed assessing new, rapidly developed and deployed technology could help biopharmas adopt advanced tech post-commercialization.
- Wish SUS Cost Less? Survey Says Your Peers Do, Too
- A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions
- Drug Product Formulation & Process Development: The Must-Have Skills At A Glance
- Tips For Deploying Advanced Modeling In Commercial Phase Bioprocessing
- Should You Be Using Unique Container Identification?
- The Influence Of Flows In cGMP Architectural Design
- Are You Taking The HPCs In Your ADCs Seriously?
GUEST COLUMNISTS
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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.
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Should You Be Using Unique Container Identification?
Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.
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The Influence Of Flows In cGMP Architectural Design
In drug manufacturing facility layout, balancing the roles of layout and procedure plays a critical role. This article examines how the interplay may be resolved, and how this resolution affects facility layout during design.
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NIST, IBBR Researchers Explore Excipient-Influenced mAb Dynamics At Atomic Level
Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations.
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FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)
The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.
BIOSIMILAR WHITE PAPERS
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2024 Global Biopharma Sustainability Review
What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
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The Advantages Of A Blended Learning Approach In Operator Training5/30/2024
Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies2/24/2023
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
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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.
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The Latest Trends In The Prevention And Treatment Of Cervical Cancer2/8/2024
Unearth what immune checkpoint inhibitors are showing promise in treating cervical cancer and how advancements in these treatments paired with additional prevention strategies are improving patient outcomes.
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Five Essentials For Accurate Oligonucleotide Chemistry3/4/2024
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
BIOSIMILAR APP NOTES & CASE STUDIES
- AAV Production In Suspension HEK293 Cells With Single-Use Bioreactors
- The Use Of Injectable Packaging From Early Development To Commercialization
- Transition To Closed Processing Systems For Cell Expansion And Banking
- Process Control And Performance Of A Virus Filtration System
- Implementation Of Raman Spectroscopy For In-Line Monitoring
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
- Bio-Thera Solutions And Biogen Publish Phase 3 Clinical Trial Data For TOFIDENCE™ (BAT1806/BIIB800), An Approved Biosimilar Referencing Tocilizumab In Arthritis Research & Therapy
- Tanvex Forging Strategic Alliance With Bora Pharmaceuticals
- Evernorth Announces Another Step Forward In Lowering Drug Prices By Making A Stelara Biosimilar Available At $0 Out Of Pocket For Patients Early Next Year
- U.S. Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies For Interchangeable Biosimilars; Oppose Pharmacy Substitution Of Non-Interchangeable Biosimilars
- IND Application Of Henlius' Pembrolizumab Biosimilar Approved By NMPA
- Biocon Biologics Secures Market Entry For Bmab 1200, A Proposed Biosimilar To Stelara®, In Europe, UK, Canada, And Japan
- ADVANZ PHARMA And Enzene Enter An Exclusive Partnership For Biosimilar Development And Commercialisation
- European Commission Approves Celltrion's SteQeyma (CT-P43), A Biosimilar To Stelara (ustekinumab), For The Treatment Of Multiple Chronic Inflammatory Diseases
NEWSLETTER ARCHIVE
- 09.12.24 -- Get The Most Out Of Your Filtration Processes
- 09.12.24 -- FDA Issues Draft Guidance On Use-Related Risk Analysis
- 09.11.24 -- All Eyes On Sustainability
- 09.05.24 -- Why Pharma 4.0 May Not Be Optional For Much Longer
- 08.29.24 -- Wearable Injectors: An Alternative To Traditional Intravenous Administration