Newsletter | October 9, 2025

10.09.25 -- Ivory Tower To CDMO: Universities Successfully Outsource Drug Development

SPONSOR

Webinar: Leveraging Integrated DS/DP Manufacturing to Mitigate CMC Risks and Simplify Commercial Supply

Discover how Lonza's integrated CDMO model unites drug substance and drug product manufacturing to drive efficiency and quality. In this webinar, experts share real-world lessons from complex biologics programs, highlighting streamlined tech transfers, shared quality systems, and cross-functional collaboration. Learn how early alignment and proactive problem-solving accelerate timelines, ensure regulatory readiness, and deliver successful commercial outcomes. Click here to learn more.

INDUSTRY INSIGHTS

Regulatory Considerations For First-Time Drug Developers

Navigate the challenging path from concept to clinical reality by partnering with an experienced CDMO that can provide the expertise needed to move your therapeutic forward.

Empowering Patients With Self-Administration Drug Delivery Devices

Discover how these devices offer solutions to the challenges of precise dosing, patient compliance, retention, and safety, uplifting the overall trial experience and providing real world insights.

Understanding And Mitigating Oxygen Heterogeneity In Large-Scale Bioreactors

Oxygen heterogeneity requires careful control for successful biopharma manufacturing and technology transfer. Unlock your production potential by mastering the distribution of oxygen.

FEATURED EDITORIAL

Ivory Tower To CDMO: Universities Successfully Outsource Drug Development

Let’s be honest: for professionals at CDMOs, dealing with university-based clients can feel like trying to run a development campaign through a distortion field. Even when inventors are “spun out” into the “real world” as biotech entrepreneurs, breaking through to the realities of progressing molecules is challenging.

Automation In The Lab: Lessons From Successes And Setbacks

Real-world examples have shown that, in some labs, manual screenings disappeared altogether, replaced by automated runs covering entire departments, saving time, multiplying output, and producing data sets robust enough to open new scientific doors.

INDUSTRY INSIGHTS CONTINUED

Accelerate And De-Risk Bioconjugate Drug Development

With a growing interest in developing new and improved bioconjugate drugs, explore an “innovation through collaboration” approach that can facilitate access to next-generation conjugation technologies.

Elevating Downstream Process Development With Real-Time Data Monitoring

Learn how real-time monitoring with PAT enhances process control, shortens development timelines, and supports the shift toward continuous manufacturing in biopharmaceutical production.

Driving Operational Excellence Using Machine Learning

Using the case study of afucosylated glycan levels, we highlight the impact of data-driven methodologies on improving process outcomes and ensuring high standards of quality and reliability.

Development Of A Non-Standard Protein Therapeutic

While no two programs are alike, see how a customized approach to biologics development can overcome unique molecular challenges and accelerate your path to the clinic.

Seizing The Opportunity Under EMA's Streamlined Guidelines

A major change in the regulatory framework for biosimilars is coming. Take proactive steps now to reduce development costs, accelerate approval, and unlock new opportunities in the shifting landscape.

Gliding Towards De-Risked Combination Product Development

Selecting a plunger stopper is key to de-risking the development and launch of biologic combination products — unearth how a new product influences exposure to extractables and leachables.

Insourcing And Outsourcing: Meeting Drug Development Timelines, Budgets

How do biopharma companies solve the common challenge of increasing output while decreasing headcount? Consider three options: temporary staffing, outsourcing, and insourcing.

SPONSOR

Join 1,000+ pharma, biotech, and drug delivery professionals at the PODD: Partnership Opportunities in Drug Delivery Conference, October 27–28 in Boston. Featuring 10 technology tracks, pharma company spotlights, 1:1 partnering, and more. Attendees will also hear from leaders at companies including AbbVie, Amgen, AstraZeneca, Biogen, Eli Lilly, GSK, Moderna, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and others. Register at PODDConference.com with code LSL20 for 20% off.

SOLUTIONS

Capabilities Update April 2025: Fill/Finish

This presentation highlights how simplified execution with development, filling, and analytics under one roof ensures safe, efficacious products reach patients in need.

Reducing CMC Risk With Proven Analytical And Formulation Expertise

Review real examples of how this outsourcing partner helps drug sponsors through transparency that empowers, integration that simplifies, methods that de-risk, and experience that accelerates.

Achieve Your Commercialization Goals For Sterile Injectables

You can count on our extensive scientific and manufacturing expertise, stringent quality standards, and highly responsive customer service to ensure timely delivery of your life-changing products.

Capabilities Update April 2025: Large Molecule Development

Associate Director kojoX and Technology Development, Rasmus Petersen, presents a high-level overview of FDB’s capabilities, its global facilities network, and capacity updates for BIOLOGICS.

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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