Newsletter | March 19, 2026

03.19.26 -- The Long Road To U.S. Vaccine Manufacturing

SPONSOR

Webinar: Flexible Therapeutic Development: Balancing Speed, Cost, and Process

Behind every molecule is a unique development strategy. In this webinar, KBI Biopharma showcases its flexible microbial protein platforms designed to accelerate first-in-human programs with speed, cost-efficiency, and process robustness. Explore considerations in cell line development, fermentation, and purification, and learn how platform-based approaches and robotic workflows align milestones from proof-of-concept through toxicology material generation with no license fee to evaluate. Click here to learn more.

INDUSTRY INSIGHTS

Optimization Of A Glycosylation Analytical Method

The predictive models created using “self-validating ensemble modeling (SVEM)” on the definitive screening design data reliably predicted the behavior of the chosen responses.

Optimize Your CLD With Innovative And Flexible Transposase Technology

To ensure speed and stability in the manufacture of your complex biologic — mAbs, antibodies, fusion proteins, and/or antibody drug conjugates — prioritize a high-performance CLD workflow.

Getting To The Heart Of CDMO Tech Transfer Excellence

Discover five key factors that drive a seamless and efficient technology transfer, highlighting how a culture of technical expertise, customer focus, and operational flexibility is crucial to success.

FEATURED EDITORIAL

The Long Road To U.S. Vaccine Manufacturing

GeoVax CEO David Dodd sings the praises and is grateful for the program-enabling relationships he has in Europe. At the same time, he harbors lingering disappointment. From the outset of its formation, the biotech has desired to work with U.S.-based CDMOs. But he says he will not give up. “One way or the other,” Dodd says, “GeoVax will have U.S.-based manufacturing.”

Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE

By continuously analyzing spent media, researchers can estimate reaction rates at regular time points, providing a granular view of cell metabolism.

INDUSTRY INSIGHTS CONTINUED

Developing New Medicines Through Artificial Intelligence

Embrace the future of drug development by leveraging AI and innovative protein synthesis technologies to accelerate the creation of effective therapies and transform patient outcomes.

Solving Atypical Protein Expression With Transposases

To optimize productivity and avoid costly delays for complex proteins, researchers should leverage flexible platforms and experienced CDMOs in cell line development.

Scaling Manufacturing Flexibility For Fill-Finish Commercial Success

Pharma and biotech developers rely on adaptable fill‑finish capacity to meet evolving market demands, scale products from clinical to commercial, and respond rapidly to public‑health emergencies.

End-To-End Biologics Support

What does it take to move a molecule from concept to clinic? It’s often more steps – and more time – than biotechs think.

Human Performance In Pharma: Strengthening The Biotech Workforce

Transforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.

Supply Resiliency For Bioprocessing Amid Global Volatility

Build bioprocessing resiliency with strategic supply chain management. Learn to meet quality, compliance, and time-to-market demands amid global volatility with effective sourcing.

Charting A Successful CMC Journey For Your ADC Drug Product

These real-world case studies highlight best practices and strategies to optimize bioconjugate drug product tech transfers and supplies in the clinical or commercial phase.

SPONSOR

Join us for two Outsourced Pharma Capabilities Update sessions featuring leading CDMOs sharing their facilities, timelines, and available capacity for development and manufacturing. The April 21st session focuses on small molecule drug product capabilities, while April 22nd highlights fill-finish technologies including sterile filling, lyophilization, and advanced packaging. Expect short digital presentations to help biopharma companies identify partners that can meet their manufacturing needs. Click to learn more.

SOLUTIONS

Expertise At Every Step

We specialize in sterile injectable development and manufacturing, offering expert teams, modern facilities, and broad capabilities through collaborative partnerships.

USP <382> Functional Suitability & CCI Testing

USP <382> testing assesses packaging integrity, safety, and performance using deterministic CCIT and functional evaluations to support validation and regulatory submissions.

A Leading Drug Delivery CDMO

A look at integrated drug‑delivery expertise, scalable development paths, and advanced manufacturing that speed programs from formulation to global launch while reducing risk and improving efficiency.

Standardized Aseptic Filling Technologies For Drug Products

Robotic aseptic filling workcells deliver sterility, speed, and precision for modern drug manufacturing. Explore how they help manufacturers scale production and reduce contamination risks efficiently.

Speeding IND Timelines

You can confidently achieve critical milestones — such as submitting your IND application — or secure additional funding, backed by the robust data, quality, and reliable supply your program demands.

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. 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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