Newsletter | February 23, 2026

02.23.26 -- From Biology Grad To Manufacturing Guru

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Webinar: Beyond Standard Approaches: Integrated Thinking for Complex FIH Programs

Platform approaches can speed standard programs, but complex molecules demand deeper, integrated thinking. In this KBI webinar, experts share real-world First-in-Human examples where cross-functional collaboration, early holistic decision-making, and downstream insight transformed technical challenges into innovation opportunities. Learn how systems-level thinking links early development choices to later-stage success and reshapes unconventional FIH development paths with confidence and clarity for teams. Click here to learn more.

INDUSTRY INSIGHTS

Developability Assessment And Early Formulation Studies

Early developability and pre‑formulation screening build strong biophysical data, reduce late‑stage risks, support candidate selection, and streamline biologics development toward clinical success.

3 Keys To Success When Planning With Your CMO Partner

Once you've identified a CMO partner, how do you ensure success? The secret: planning as early as possible – while your product is still in preclinical or clinical development.

A Bridge To The Future: Our World-Class Site In Bridgeton

Bridgeton's sterile site unites advanced filling tech, integrated quality, and scalable capacity to streamline complex injectables, reduce risk, and support efficient progress to commercial supply.

FEATURED EDITORIAL

From Biology Grad To Manufacturing Guru

Stephanie Wimberly graduated from Howard University in 2012 with a degree in biology. What was next? An online search turned up an intriguing area – pharmaceutical manufacturing. “It was manufacturing,” she thought, “but I could still help patients." It was a fortuitous start. This young female professional with a penchant for helping others started a manufacturing career that has wound through GSK, and leadership roles at Shire/Takeda. Now as a manufacturing consultant, here is some of her advice (for life and career).

Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers

Effective mAb and ADC manufacturing control strategies evolve through the phases. These four principles should guide your strategy design as goals shift.

INDUSTRY INSIGHTS CONTINUED

Accelerating A Complex Molecule From CLD To cGMP In 12 Months

Learn how to mitigate technical risk, implement parallel process development, and design custom purification strategies for highly sensitive novel modalities to accelerate to cGMP material.

Liposomes — Challenges And Opportunities

Liposome technology is an effective drug delivery tool but still presents difficulties. Learn how developers are meeting these challenges and the opportunities for advancement to maximize liposome usefulness.

Flow Chemistry For Contemporary Isotope Labeling

Gain insight into how late‑stage exchange and flow‑based methods enable efficient access to labeled molecules for pharmaceuticals, mechanistic studies, and analytical applications.

Optimizing Bispecific Antibody Expression

Discover how diagnosing ribosome pausing sites and optimizing codon usage dramatically improves bispecific antibody titers, turning difficult-to-express candidates into viable therapeutics.

Can Your Cleaning And Monitoring Withstand Regulatory Scrutiny?

Explore facility cleaning, monitoring, and disinfection strategies to meet regulatory standards, emphasizing planning, stakeholder involvement, testing, documentation, and improvement.

Accelerating Drug Development: Flexible And Fast DNA-To-IND Programs

Assimilate how tailored approaches and innovative technologies enable fast and flexible development workflows, ultimately supporting rapid therapeutic breakthroughs.

Expert Insights On Outsourcing In A Dynamic Biopharma Landscape

A standardized, end-to-end, multi-plant biomanufacturing model enables faster timelines, flexibility, and consistent global quality, turning CDMO partnerships into a sustained competitive advantage.

Why The Latest E2500-25 Standard Revision Demands Immediate Action

The updated E2500-25 standard transforms pharmaceutical manufacturing with a proactive, risk-based approach, enhancing compliance and accelerating the delivery of therapies to patients.

Achieve Speed, Stability, And Compliance In Cell Line Development

Partnering with a CDMO that demonstrates innovative and commercially validated cell line development capabilities is essential to protecting your market position and securing investor support.

End-To-End Biologics Support

This center offers a comprehensive suite of services for researchers seeking the discovery and engineering of potent and functional antibodies.

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Where Biologic Stability Programs Fail—and How ICH Q1 Can Help You Get It Right

Stability is no longer a back-end regulatory checkbox. In this Catalent webinar, experts unpack how the draft ICH Q1 guidance moves stability to the front lines of biologics development and risk management. Learn what’s changed, why legacy approaches fall short, and how to redesign stability programs using case studies to uncover hidden risk early. Click here to learn more.

SOLUTIONS

Path To First-In-Human

Unlike traditional CDMOs that stitch services together, we connect our capabilities to streamline biologics development through Path to First-in-Human.

Aseptic Manufacturing: Fill/Finish For Vials, Syringes, Cartridges

Sterile fill/finish requires isolator technology and regulatory compliance. From clinical development to commercial scale, technical expertise ensures the integrity of liquid and lyophilized injectables.

Leveraging Transformational Formulation Technologies: LNPs

Increasingly we are seeing customers that are looking for specialized formulation capabilities and, specifically, expertise in developing lipid nanoparticles.

Your Contract Manufacturing Partner

Our injectable and solid dosage form products are manufactured at state-of-the-art facilities located in the Madrid metropolitan area of Spain.

Site-Specific ADC Conjugation

Uncover efficient site-specific conjugation technology for generating ADCs and other conjugate modalities, such as AOCs and conjugates for diagnostic applications.

Our Biotech Success

Simon Westbrook formed an idea for a complex fusion chimera protein he believed could interrupt the neurotrophin pathway, and being a true virtual company, he needed a CDMO.

Accelerate Your Pipeline With CDMO Collaboration

A CDMO can augment your capacity and expertise, refine your processes, and ultimately shorten your time to market. Look at best practices that make working with a CDMO as efficient as possible.

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Explore 20+ new CDMO presenters in quick 20-minute sessions during the Outsourced Pharma Capabilities Update. Sessions include Analytical Services, ADC, Large and Small Molecules, Cell and Gene Therapy, and Fill/Finish. Each session offers a quick, informative look at capabilities to help you find the best-fit partner. Registration and on-demand access are all free! Click here to learn more.

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.

Connect With Outsourced Pharma: