Newsletter | January 26, 2024

01.26.24 -- Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies

FEATURED EDITORIAL

Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 3

This is the third article in a series of three articles. It continues the discussion by sharing a generic example of continuous GR&R using Minitab. Study setup, the role of the study director, analysis, and case studies are examined.

INDUSTRY INSIGHTS

Considerations To Alleviate Sticking And Picking In Tablet Manufacturing

Find out how compression tooling manufacturers can identify potential sticking and picking issues before tablet and tool designs have been finalized.

From Discovery To Commercial Promise With Philogen’s Dr. Dario Neri

In a recent episode of Business of Biotech, Philogen CEO Dr. Dario Neri sat down to explore his journey from academia to startups, as well as Philogen's own trajectory.

Overcoming Formulation Challenges For mRNA, High-Concentration Proteins

Learn about the new challenges being introduced to the development life cycle by increased demand for protein delivery and the emergence of advanced modalities — including mRNA.

Process Redesign For Sustainability In Small Molecule Manufacturing

Review the optimization of the manufacturing process of a pharmaceutical intermediate and discover how yield can be improved substantially via suitable reaction engineering.

The Path To Confidence At Every Point Of Connection

Explore practical information on key issues including extractable/leachable testing in components, freeze/thaw in single-use assemblies, efficiencies driven by SUT advances, and more.

Considerations And Strategies For Oligonucleotide Manufacturing Scale-Up

To keep up with oligonucleotide demand, manufacturing needs to shift toward larger-scale processes, but this up-scaling process brings challenges that must be addressed.

Risky Assumptions For Addressing Limited Bioavailability

Bioavailability challenges are an inherent part of the drug development process. Review some risky assumptions surrounding bioavailability during development and key considerations for addressing them.

SOLUTIONS

Psychedelics: Drug Development Capabilities

Compliance Program For EU Annex 1 Container Closure Requirements

Controlled Substances

EVENTS

Aseptic Filling: Reducing Risk And Improving Sterility In GMP Manufacturing

Wednesday, January 31, 2024 | 4:00 p.m. GMT / 11:00 a.m. EST / 8:00 a.m. PST | One Hour  
Join us for an exclusive online joint webinar hosted by Cytiva and Singota Solutions. Connect with industry leaders on Wednesday, January 31, 2024, at 4:00 p.m. GMT / 11:00 a.m. EST / 8:00 a.m. PST for an immersive experience, as we dive deep into Cytiva’s expertise and Singota's top-tier aseptic filling capabilities, and gain insights into reducing risk and improving sterility. Don't miss out on this can't-miss event led by bio and pharma experts. Mark your calendar for a transformative learning experience! Register now

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