The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.
- A Structured Approach To Regulatory Information Management Vendor Selection
- Getting To Know MAM, The New Quality Control Strategy On the Block
- Navigating China's Biologics Approval And Accelerated Pathways
- Shocking! Biotech Facilities Don't Maintain Themselves
- Green Gains In Biopharma Without Closing Facilities?
- How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing
- Risk And Supply Chain Continuity Management: Biologics Industry Perspectives
GUEST COLUMNISTS
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Getting To Know MAM, The New Quality Control Strategy On the Block
When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis. This article explores technical considerations for this emerging strategy.
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Navigating China's Biologics Approval And Accelerated Pathways
Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.
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Shocking! Biotech Facilities Don't Maintain Themselves
Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.
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Green Gains In Biopharma Without Closing Facilities?
Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.
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How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing
To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts.
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Risk And Supply Chain Continuity Management: Biologics Industry Perspectives
We spoke to three long-standing members of BioPhorum’s Risk and Business Continuity Workstream about their companies’ approaches to risk management, supply chain continuity, and what they learned from the pandemic. Among them are Melinda McCants, senior resiliency officer at Amgen.
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Understanding And Navigating Diverse Regulatory Environments
Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.
BIOSIMILAR WHITE PAPERS
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Containment Solutions To Help Emerging Biologic Companies Get Products To The Market Faster
Gain solutions on how to set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.
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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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Data Utilization For Advanced Analytics And Near Real-Time Monitoring8/16/2022
Control, monitor, and analyze equipment, processes, results, and data in near real time and make data-driven decisions at both the process and plant levels.
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Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process2/8/2024
Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
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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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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars2/9/2024
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
BIOSIMILAR APP NOTES & CASE STUDIES
- COVID-19 Impact To Biological Drug Products Safety
- Determining RNA Integrity And Purity By Capillary Gel Electrophoresis
- AAV Production In Suspension HEK293 Cells With Single-Use Bioreactors
- Performing A Tangential Flow Filtration (TFF) Optimization Study
- How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL
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
- Phase 3 Clinical Trial Completed In China For Boan Biotech’s Dulaglutide Injection BA5101. BLA To Be Filed Soon
- Biosimilars Forum Urges Congress To Support Free Market Competition And Lower Prescription Drug Prices For Patients By Reforming Pharmacy Benefit Managers
- Celltrion USA Completes Submission Of Biologics License Application (BLA) To U.S. FDA For CT-P39, An Interchangeable Biosimilar Candidate Of XOLAIR® (omalizumab)
- Samsung Bioepis Presents Two Abstracts For Its Immunology Portfolio At The 2024 American Academy Of Dermatology (AAD) Annual Meeting
- Fresenius Kabi’s Biosimilar Tyenne (tocilizumab-aazg) Becomes The First IV And Subcutaneous Tocilizumab Biosimilar Approved By The FDA
- The Cigna Group Raises Long-Term Growth Target, And Launches New Innovative Solutions At 2024 Investor Day
- Sandoz Receives FDA Approval For First And Only Denosumab Biosimilars
- WEZLANA™ (Ustekinumab), A Biosimilar To Stelara®, Now Available In Canada For Certain Chronic Inflammatory Diseases
NEWSLETTER ARCHIVE
- 03.14.24 -- Understanding & Navigating Diverse Regulatory Environments
- 03.07.24 -- Cardinal Health Report Examines Milestone Year In Biosimilars
- 03.03.24 -- Samsung Bioepis Initiates Ph. 1 For Keytruda Biosimilar
- 02.29.24 -- Samsung Bioepis Initiates Ph. 1 For Keytruda Biosimilar
- 02.22.24 -- Analyzing & Kickstarting Organizational Quality Maturity