Newsletter | November 20, 2023

11.20.23 -- Understanding The FDA's Current Focus On Risk Evaluation And Mitigation Strategies


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Understanding The FDA’s Current Focus On Risk Evaluation And Mitigation Strategies

The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios.

Backpacks And Biotech With Luke Timmerman

From his vantage point as an independent biotech journalist, Luke Timmerman has been watching the expansions and retractions of the industry for a couple of decades now. His unique perspective is hard to equal, and that perspective is, despite tough markets and tepid public sentiment, decidedly bullish. 


Utilizing Nanoparticle Technologies For A More Sustainable Value Chain

The pharma industry is identifying new ways to make processes more sustainable. Discover how nanoparticle engineering technology can both empower sustainability goals and lead to better patient outcomes.

Reducing The Level Of Host Cell Proteins In The Bioreactor Harvest

Learn how MilliporeSigma helped a customer drastically reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial.

Three Strategies To Better Batch Visualization In Life Sciences

Learn how new batch solutions deliver the breadth of batch management and control that manufacturers need to thrive amid economic and business pressures and uncertainties.

Media And Feed Development: A Guide To Workflow Optimization

Gain insight into each development stage and explore best practices that will help achieve your project goals on time and within budget.

Determining Thermal Stability Of Antibodies With A Nano DSC

Explore the performance of an instrument with data analysis software capabilities that easily deconvolutes thermograms, enables differentiation between individual and interacting domains, and reports accurate Tm values.

Customer-Supplier Collaboration Overcomes Supply Chain Limitations

Better understanding the root cause of a supply chain issue helps set more realistic timelines for customers and generates more collaborative problem-solving efforts between drug manufacturers and their suppliers.

Delivering Genetic Editing Therapies To Market

Manufacturers with proven expertise in areas such as viral vector production and analytics are needed now more than ever to get breakthrough, deliverable gene editing therapies to patients.

Engaging Early In Process Development To Bring mRNA Sequences To Life

Examine why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.

Continuous Processing For Enhanced Monoclonal Antibody Production

Explore highlights from a recent webinar where experts from Cytiva and Chugai Pharmaceutical, a Roche company, discussed their unique collaboration for the continuous processing of mAbs.

Benefits Of RABS, Isolator Tech In A Changing Regulatory Landscape

Restricted access barrier systems or isolator technologies are an integral component of quality control. Understanding the key elements of each ensures the most informed decision for your product.

The Promise Of PCM: Getting To Maturity

PCM offers several advantages, including streamlined development and increased flexibility. Review the key drivers for PCM as well as the hurdles that stand in the way of industrywide adoption.

Simplify The Qualification Of Your GMP Proteins With Maurice

Discover a fast, easy, and streamlined method for characterizing the identity and purity of commonly used GMP cytokines in immune cell therapy manufacturing using an automated capillary electrophoresis instrument.

De-Risking A Bioconjugate’s Development Path From Discovery To Clinic

Understanding the obstacles you may face during bioconjugate development, as well as the tools available to help overcome them, can help streamline your product’s path-to-market.


Webinar: Reaching Biologics License Application Success Using a New, Fast-Track Approach To Process Characterization

Join us on November 30th to learn how in-depth knowledge of microbial processes and an unparalleled understanding of process characterization can be used to design targeted biologics license application (BLA) programs that can be executed effectively, while managing risks for the objective of achieving a quick regulatory pass. Click here to learn more.


Experience Matters In Supporting Large Tech Ops Initiatives

Sterile Injectables Made With Intelligent Collaboration

Allogeneic And Autologous Cell Therapy CDMO Services

Biopharma Capabilities Overview

Control Your Bioprocess Development: Faster Decisions With Quality Data


Join Bioprocess Online Live for a discussion on two approaches to adoption of computational technology — do-it-yourself and outsourcing. Whether you're considering how AI and ML can increase drug discovery, design, and development efficiencies, dabbling in it already, or leading the charge, you won't want to miss this conversation from the edge of what's possible. Registration is free thanks to the support of Cytiva. Register now


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