Drug Development White Papers & Articles
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How Ex-CDMO Hires Strengthen Innovator Companies
6/13/2023
The CDMO environment demands individuals be able to think on their feet, wear many hats, be accountable to both scientific and business goals, and work well with a diverse group of colleagues and partners.
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Establishing Analytical Methods For mRNA-Based Therapies
6/13/2023
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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The Growth Of Sterile Injectables
6/1/2023
Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.
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Nonrodent Models: Minipig Specialty Capabilities
6/1/2023
The minipig's similarity to humans, availability, known disease status, and feasibility of genetic manipulation offer advantages over traditional species, impacting ethical considerations and cost of animals in biomedical research.
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CDMO Management for Sponsors — Part 2: Handling SOPs, Multiple Partnerships, and M&A Disruptions
5/30/2023
Day-to-day discussions between technical teams and regular brainstorming/exchange-of-information meetings are commonly understood to be vital to a partnership — ensuring the sponsor and vendor understand each other’s long- and short-term priorities — but problem-solving and mediation are equally critical communication skills.
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CDMO Management for Sponsors — Part 1: Identify Partners and Nail Project Kickoff
5/30/2023
Identifying an appropriate CDMO partner and establishing relationship structure/expectations early is an intrinsic part of leveraging the CDMO to provide the sponsor a competitive advantage. A good partner blurs the line between third-party service and extension of your company.
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De-Risk Development: Nonclinical Strategy And Study Design
5/18/2023
Whether you are a researcher, scientist, or industry professional, access these insightful guides and checklists that provide valuable advice and best practices for planning and executing nonclinical studies.
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Controlling Trace Impurities In Chemically Defined Media
4/10/2023
Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.
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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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Leveraging The Bolar Exemption To Accelerate Market Access
3/17/2023
Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.