Newsletter | April 20, 2026

04.20.26 -- A CMC Professional At Sanofi Focuses On Arrangements Over Relationships

SPONSOR

Webinar: Early Developability Assessment for Antibody Based Therapeutics

De-risk multi-specific antibody development with Lonza’s integrated toolbox approach. Learn how in silico and in vitro screening can uncover developability, manufacturability, potency, and immunosafety risks early. Discover how smarter candidate selection, stronger early data, and scalable expression systems can help accelerate timelines, reduce downstream setbacks, improve lead prioritization, and support confident clinical advancement in a competitive biologics landscape. Click here to learn more.

INDUSTRY INSIGHTS

De-Risking A Novel Valve Component With Standard Syringe Systems

A novel valve provides dual‑chamber functionality within standard syringes, keeping two liquid drugs separated until injection while reducing development risk through advanced modeling.

Beyond Solid Phase Synthesis

Explore how enzymatic methods, real-time analytics, and AI optimization enhance long-sequence TIDES, improving control, speeding timelines, and supporting sustainable production.

Building A Biomanufacturing Ecosystem For Supply Agility Starts Early

A unified, modular biomanufacturing ecosystem combining rapid CLD, flexible purification, and scalable global capacity can accelerate production and strengthen supply agility amid rising demand.

FEATURED EDITORIAL

A CMC Professional At Sanofi Focuses On Arrangements Over Relationships

Manda Pasarkar, Global Regulatory Affairs, CMC Head, Sanofi, has overseen global, multi-billion-dollar portfolios of products from early development to commercialization. She spoke with Chief Editor Louis Garguilo on her outsourcing strategy and philosophy.

Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes

The outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.

INDUSTRY INSIGHTS CONTINUED

Precision Control In Animal‑Free Raw Materials

Animal‑free raw materials offer adjustable attributes, controlled manufacturing, and consistent nutrient profiles, ensuring reliable performance and customizable solutions across multiple production processes.

Using Novel Biological Responses For Robust Cell-Based Potency Assays

Ensure the potency and efficacy of your biologic products with a GMP-compliant potency bioassay, offering accurate real-time assessments for GMP release and stability testing.

Streamline Biopharmaceutical Manufacturing With Versatile Platforms

Gain insights into how standardized quality controls, robust analytics, and streamlined processes can improve efficiency, reliability, and scalability across the development lifecycle.

Enabling Digital Twins With Computational Fluid Dynamics Modeling

Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.

Support Of Technical Transfer Through Understanding Equipment

See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.

Scalable Protein Expression With Technology

Uncover the benefits, including speed, simple fermentation regimes, and robust, scalable processes that can be tuned according to the specific objectives of a program.

Overcome Common Pre-Filled Syringe Challenges Through Partnership

One of pharma’s fastest-growing formats promises safety and efficiency—but pre-filled syringes aren’t so easy to produce. Learn what stands in the way.

Prefillable Syringe Success Factors For Emerging Biotech Companies

Navigating PFS selection requires balancing complex regulatory requirements and supply chain logistics. Adopting an integrated system approach provides unified data and streamlined documentation.

Digitized Solutions To Increase Visibility And Streamline Communication

When email-based escalation management creates compliance and visibility gaps, a centralized digital solution helps manufacturer and PSP teams act faster and with greater accountability.

SPONSOR

Webinar: From Insights to Impact: Predictive Models and PAT for More Efficient and Robust Biologics Manufacturing

Take biologics from bench to batch with greater confidence. This webinar explores how predictive modeling, mechanistic insights, and real-time PAT strengthen scale-up, tech transfer, and manufacturing. Learn how to reduce risk, optimize performance, and improve supply reliability across drug substance and lyophilized drug product development, accelerating the path to commercial readiness with data-driven decision-making.
Click here to learn more.

SOLUTIONS

API Sterilization

Leverage advanced aseptic processing and Quality Risk Management–driven controls that help ensure sterile-grade APIs when terminal sterilization is not a viable option.

Two Sites, One Standard of Excellence

Secure your supply chain with a trusted partner in sterile manufacturing. Discover a dual-site strategy that offers crucial redundancy, high regulatory confidence, and an approach to efficient tech transfer.

How Manufacturers Are Ramping Up Capacity For Large-Molecule Growth

Michael Brotz provides an in-depth look at our Seattle site and the unique capabilities of the facility, including its single-use and stainless-steel capacity, new manufacturing lines, and more.

Meeting Global Demand: New Investments in Large-Molecule Drugs

Review biologics CDMO solutions and capacity offered, as we discuss our capabilities in mammalian cell culture manufacturing and microbial fermentation.

Unlock Robust And Reliable Stability Data With The Right Partner

Stability testing is essential to ensuring your drug’s stability, potency, efficacy, and safety under different controlled conditions throughout development, manufacturing, and life cycle management.

Product Development Services (PDS) For Steriles

Our capabilities include formulation development, compounding, lyophilization, analytical testing, and fill-finish operations.

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: