Newsletter | April 15, 2026

04.15.26 -- From IV To Subcutaneous: It's Not About Convenience, It's About System Design

SPONSOR

Webinar: The Shift to High Concentration mAbs: 3 Critical UF/DF Challenges and How to Solve Them

As monoclonal antibodies shift toward high concentration formulations for subcutaneous delivery, UF/DF operations face new challenges. In this Repligen webinar, experts explore how rising viscosity impacts flux, fouling, and aggregation and why legacy TFF approaches fall short. Learn strategies and automated TFF solutions to build scalable UF/DF processes for next generation mAbs. Click here to learn more.

FOCUS ON FILL-FINISH

From IV To Subcutaneous: It's Not About Convenience, It's About System Design

By Monika Sharma, EOSPA LLC

IV→SC transition extends beyond dose, volume, concentration, and device; it requires integrated system design, not a series of isolated optimizations.

Robotics And AI In Pharma: Driving The Next Wave Of Innovation

Article | By Victoria Morgan, West Pharmaceutical Services, Inc.

Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.

Navigating Your Holistic Approach To CCI For Biologic Drug Products

Webinar | Lonza

Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.

Early-Phase Injectable Formulation Development

White Paper | Thermo Fisher Scientific

Discover how expert-driven strategies and data-centric tools can help you overcome formulation challenges and accelerate the development of stable, high-performance injectable therapeutics.

The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

White Paper | By Tyler Jones, Ph.D. and Geno Worke, Curia

Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

FILL-FINISH SOLUTIONS

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Breakthroughs In Adaptive Robotics And Navigating Annex I - AST

SPONSOR

Webinar: Design scalable downstream processes with practical purification and analytical strategies

Explore how to build robust, scalable downstream purification processes across today’s complex modalities. In this Cytiva webinar, experts share practical chromatography strategies, advanced analytical insights using SPR and SEC-MALS, and real-world case examples to help reduce risk, solve impurity challenges, accelerate development, and strengthen long-term internal process knowledge and operational efficiency from proof of concept through scale-up. Click here to learn more.

FOCUS ON DOWNSTREAM MANUFACTURING

mAb Purification: A Two-Step Approach Using A Strong Mixed-Mode Resin

Webinar | Bio-Rad Laboratories, Inc.

Elevate your mAb purification with a two-step chromatography strategy. Simplify the process, eliminate an entire step, and achieve substantial savings in time and material costs.

BsAb Development With Structural Innovation, Enhanced Manufacturability

Article | By Kihong Kim, Samsung Biologics

Bispecific antibodies (bsAbs) offer transformative therapeutic potential through dual-target engagement, but their complex structure presents significant manufacturing challenges.

Innovation And Evolution Of Affinity Chromatography Resins

White Paper | Ecolab, Purolite Resins

Gain insight into how innovations in ligand design and resin manufacturing have improved monoclonal antibody purification by enhancing selectivity, stability, and process economics.

DOWNSTREAM MANUFACTURING SOLUTIONS

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Host Cell DNA Quantification Kits - Cygnus Technologies Inc.

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The Single-Use Platform Revolutionizing Antibody Production - W.L. Gore & Associates

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