Newsletter | February 19, 2026

02.19.26 -- End-To-End ADC Manufacturing Works Best With Active Sponsor Oversight

SPONSOR

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

Optimized Bioprocessing: Functional DOE With Time-Based Insights

Webinar | Samsung Biologics

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.

Operational Success By Strategic Investment

White Paper | August Bioservices

Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.

Demonstrating Value Throughout The Product Development Lifecycle

E-Book | SGS

Examine how a partner with extensive capabilities and expertise adds value to drug development and helps to solve complex formulation, analytical, and manufacturing challenges our clients face.

FEATURED EDITORIAL

End-To-End ADC Manufacturing Works Best With Active Sponsor Oversight

From The Editor | 

ADC success is less about perfect execution and more about early signal detection, tight communication, and decisive governance.

High Specific Productivity For Leaner Sustainable Bioprocessing

Guest Column | Bioprocess Online

Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.

INDUSTRY INSIGHTS CONTINUED

Tech Transfer Answers: How To Successfully Onshore A Mid-Phase Project

Article | Avid Bioservices

Onshoring biomanufacturing operations is an increasingly common decision. While a mid-phase tech transfer from international to domestic CDMO can be complex, the right partner can ensure success.

Quicker Development Using Cell Line Integration, End-To-End Support

Article | Lonza

Despite challenges with mammalian host cell line diversity, Lonza's mitigation strategies drive efficiency and reproducibility, maximizing cell growth and product quality.

Manufacturing Strategies And Facility Design For Patient-Centric Delivery

Webinar | FUJIFILM Biotechnologies

De-risk the supply chain, accelerate time to market, and reduce costs by selecting an optimal manufacturing strategy and leveraging the right technologies for therapeutic protein production.

CHO K1 Cell Culture Process Intensification For Production Of IgG mAbs

Poster | Thermo Fisher Scientific

Discover how our optimized CHO K1 cell lines achieved up to an 80% increase in titer while maintaining product quality through molecule-specific process development strategies.

Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?

White Paper | BD Medical - Pharmaceutical Systems

Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

Simulated Control Strategy For Product Diversion Management

Poster | Resilience, LLC

Consider this manufacturing platform integrating perfusion bioreactors, continuous product capture, low pH viral inactivation, polishing, viral filtration, and formulation steps.

Development, Manufacture Of Biopharmaceuticals In Microbial Systems

Webinar | Lonza

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. 

Modernizing Clinical Trial Logistics To Deliver Value

White Paper | Thermo Fisher Scientific

Explore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.

Roundtable: Fill And Finish Contract Manufacturing Trends

Q&A | Kindeva

Fill‑finish is evolving as biologics and advanced therapies shift capacity and sterility needs. Automation, emerging tech, and data‑driven methods are boosting efficiency in aseptic production.

Unlocking The Potential Of Biocatalysis

White Paper | Asymchem

Biocatalysis delivers cleaner, more selective pharma processes while cutting energy use and waste. Engineered enzymes broaden their reach, enabling faster development and greater sustainability.

Transitioning From Vial To Prefilled Syringe

Article | Catalent

Understand how formulation development for a prefilled syringe affects manufacturing, driving the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Engaging A Single CDMO For Comprehensive Biologics Services

White Paper | Curia

By forging strategic partnerships with comprehensive CDMOs, see how emerging biopharma firms can navigate through early-phase development and ensure a smooth transition to clinical advancement.

SPONSOR

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

Early Developability Assessment For Smarter Antibody Selection

Brochure | Coriolis Pharma

Integrated laboratory and in‑silico developability assessments provide early insight into antibody characteristics, reduce risks, streamline decision‑making, and accelerate progress.

Step Inside One Of America's Leading Protein Biologics CDMO Sites

Video | AGC Biologics

Take a behind-the-scenes look at AGC Biologics’ Seattle campus, one of the most established and productive CDMO facilities in the United States.

Productivity In mAb Capture

Video | Cytiva

See how optimized monoclonal antibody capture chromatography — especially resin selection — can improve cost efficiency, scalability, and productivity in therapeutic antibody manufacturing.

Innovation, Delivered With Certainty: Your Global CMDO

Catalog | Recipharm Advanced Bio

Review our full service offering and learn how we can help advance your project toward commercialization with speed and efficiency.

Plug Into The Future Of Bispecific Antibodies

Brochure | Lonza

Lonza’s bYlok technology is a true plug-and-play solution to bispecific antibody engineering – high product quality, simplified processes, unlocking the future.

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: