BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.
- 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?
- NIST, IBBR Researchers Explore Excipient-Influenced mAb Dynamics At Atomic Level
- FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)
- This Takeda Official Thinks Pharma 4.0 Won't Be Optional Much Longer
GUEST COLUMNISTS
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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FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)
The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July.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.
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This Takeda Official Thinks Pharma 4.0 Won't Be Optional Much Longer
Advanced technology like automation was once seen only as a competitive advantage. That viewpoint is shifting amid greater reliance on digital technology.
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2024 Emerging Trends In Cleanroom Technologies
This article shares new market research on pharma/biotech cleanroom technologies, including regional trends, prominent vendors in the space, and more.
BIOSIMILAR WHITE PAPERS
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies
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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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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Recommendations For Successful IND Approval Of RNA-LNP Drugs8/22/2023
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
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Mycoplasma Contamination In Biopharmaceutical Manufacturing2/9/2024
Learn how strict laboratory practices and routine testing for mycoplasma contamination using nucleic acid-based assays can help ensure safe, high-quality biopharmaceutical products.
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Development And Regulation Of Veterinary Monoclonals2/8/2024
Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
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Process Development Considerations For RNA-LNP Therapeutics9/13/2022
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
BIOSIMILAR APP NOTES & CASE STUDIES
- How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL
- AAV Production In Suspension HEK293 Cells With Single-Use Bioreactors
- Establishing A Robust Workflow To Identify High-Performing Clones
- Tangential Flow Filtration System Coupling To Enhance Solution Offerings
- AAV Process Intensification Using High Salt Lysis And Salt Tolerant Endonuclease
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
- 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
- Lupin Receives Health Canada Approval For Biosimilar Pegfilgrastim
- Henlius Trastuzumab Receives Approval In Canada
- GlycoNex Successfully Completes Phase 1 Study Of Denosumab Biosimilar, SPD8
- Tanvex BioPharma USA, Inc. Achieves Dual U.S. Regulatory Milestones: FDA Approves Nypozi And FDA Accepts Biosimilar Biologics License Application For TX-05
NEWSLETTER ARCHIVE
- 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
- 08.28.24 -- Evolving Design Space Requirements For Biologic Combination Products
- 08.22.24 -- Draft Guidance Offers Biosimilar Post-Approval Change Roadmap
- 08.15.24 -- Your Molecule May Be Ready, But What About Your Device?