Newsletter | May 19, 2025

05.19.25 -- Lynn Cinelli's Wake-Up Call: Pharma's Forecasting Makes CDMOs Sick

SPONSOR

Webinar: Understanding the critical role of developability assessments to enable effective lead candidate selection

Discover how developability assessments can streamline lead candidate selection in this Abzena webinar. Learn how evaluating key attributes like manufacturability, safety, and efficacy early in drug development helps reduce risks and improve clinical success rates. Explore advanced methodologies and technologies that provide comprehensive insights, enabling better decision-making and more efficient progress toward regulatory approval. Click here to learn more.

INDUSTRY INSIGHTS

Bioprocess Optimization: Leveraging Functional DOE With Time-Based Insights

Explore the key differences between traditional DOE and Functional DOE as Seongjin Kim demonstrates how the latter enhances bioprocess optimization through a fed-batch cell culture example.

Upgrade Your RFP To Ensure Successful Biologic Development

Creating a thorough, comprehensive RFP will help a CDMO partner lay the foundation for a productive partnership, fulfill your goals, and help ensure future market success for your therapeutic.

Leveraging Communal Goals To Build A Sustainable Pharma Manufacturing Future

Rethinking your company’s SOPs to reduce carbon emissions and ensure more sustainable workflows is no easy feat. The key is looking at these initiatives as a crucial, community-driven effort.

FEATURED EDITORIAL

Lynn Cinelli's Wake-Up Call: Pharma's Forecasting Makes CDMOs Sick

Lynn Cinelli, VP Global Biologics Supply Chain at Bristol Myers Squibb, has been strategizing on why Pharma is so poor at forecasting demand. "The entities that feel the pressures most may be our CDMOs,” she says. She has a better way to go about it — and it starts with the patient.

The EU Biotech Act Has Been Delayed — Here's What That Means

First due at the end of 2025, the act has been delayed until late 2026, which suggests key issues that many say hobble innovation will go unaddressed for longer.

INDUSTRY INSIGHTS CONTINUED

Mastering Technology Transfers: Our Blueprint For Success

Uncover how this expert approach to process transfer supports reliable, scalable commercial manufacturing in the rapidly growing biopharmaceutical market.

Extractables In Single-Use Systems Used In ADC Manufacturing

To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

Adapting An Adherent hCK Cell Line To A Serum-Free Suspension RCB

Learn about the development of a serum-free suspension MDCK cell line that serves as an optimal platform for isolating human influenza viruses from clinical samples and producing vaccines at scale.

Maximizing Monoclonal Antibody Manufacturing For Commercial Success

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

Enhancing Cell Line, Process Development Workflows To Streamline A Path To FIH

Leslie Wolfe, Ph.D., and Shaunak Uplekar, Ph.D., discuss how advanced cell line development and transposase technology speed up the path to toxicology and first-in-human studies.

Rapid Delivery Of Toxicological Study Material: Accelerating Development

Consider several key strategies and technologies designed to address the analytical considerations and material flows to facilitate the rapid delivery of toxicological material.

SOLUTIONS

High Resolution Mass Spectrometric Analysis Of Complex Biotherapeutics

Understand why continued research and collaboration between industry and regulatory bodies are essential to define guidelines that ensure safety and efficacy in this rapidly advancing field.

Comprehensive DoE Capabilities For Synthesis, Process Development, And NCE's

Our data-driven DoE strategies are designed to deliver higher yields, faster turnaround times, and cost-effective solutions tailored to your development goals.

Injectable Drug Manufacturing

From the production floor to the shipping door, your unique clinical or commercial requirements will be fulfilled at each step of the process.

How Does bYlok Technology Work? How Can It Improve Bispecific Production?

Witness how bYlok® technology can drive correct heavy-light chain pairing to >95% and how you can access it via a license agreement to overcome industry-wide challenges in bispecific production.

CMC Support Services

Over the course of 30+ years we’ve invested in and developed a broad range of expertise, a full suite of lab and analytical services, advanced technology platforms and a world-class facilities network.

Sterile Fill/Finish Capability

We excel in facilitating rapid product selection for clinical evaluation, backed by a comprehensive package designed to de-risk and scale-up later-stage development.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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