Newsletter | August 21, 2025

08.21.25 -- The FDA Was Darned Near Perfect, Right?

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Webinar: Nanoforming Biologics & GLP-1s: From I.V. to Sub Q & Inhaled Delivery

Discover how Nanoform's patented Bio platform is revolutionizing biologics and peptide delivery. In this webinar, explore two breakthrough case studies—subcutaneous Trastuzumab with improved stability and syringeability, and inhalable Semaglutide for deep lung delivery. Learn how these innovations can boost patient comfort, compliance, and outcomes. Don’t miss insights shaping the future of patient-friendly therapies. Click here to learn more.

INDUSTRY INSIGHTS

Leveraging Bio-Functional Assays For Charged Variants Characterization

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

The Relevance Of Polymorph Screening In The Pharmaceutical Industry

Polymorph screening has evolved tremendously. The combination of high-throughput experimentation with fast and efficient characterizations and computational predictions is offering new screenings.

Reducing Risk And Timelines In Cell Line Development

Accelerate your biologic development by adopting faster, more reliable clone selection methods that reduce time and resources while improving the likelihood of identifying stable, high-producing cell lines.

FEATURED EDITORIAL

The FDA Was Darned Near Perfect, Right?

Let's return to minutes before Donald Trump became president in January, to a time when the FDA was near perfect. That’s what one would assume today listening to those up in arms over the agency. Of course, the reality was quite different. Chief Editor Louis Garguilo helps regain perspective.

Functional Antibody Screening With Abalone Bio's Richard Yu, Ph.D.

In this episode of "Better Biopharma," Abalone Bio's CEO and co-founder, Richard Yu, Ph.D., explains how the company's functional antibody selection technology (FAST) platform differs from traditional affinity screening.

INDUSTRY INSIGHTS CONTINUED

Unlocking Efficiency In Large-Scale Microbial Manufacturing

Gain insights into how expert teams and the right tools help build resilience into manufacturing systems and tackle small, often-overlooked issues before they become costly problems.

The Role Of Training Devices And Education In Self-Injection Therapies

Review the evolution of injection devices and prefilled syringes, the benefits of training devices combined with patient education, and an empirical look at patient training.

Use Of Reconstructed Tissue And 3D Printed CT-Based Nasal Casts

Reconstructed nasal epithelium and CT-based 3D nasal casts provide more predictive, physiologically relevant models for assessing nasal drug delivery, improving accuracy in formulation development.

Beyond Conventional: How This CDMO Model Is Empowering Emerging Biotechs

For emerging biotechs looking to refine their development processes and boost their chances of commercial success, exploring these partnership opportunities could prove invaluable.

Microbial Manufacturing Platform For Non-Platform Proteins

Discover a cost-effective, efficient technology solution that streamlines process development, reduces complexity, and enables a smooth transition from research to manufacturing.

De-Risking Your Bioconjugate's Path To Clinical Manufacturing

Explore the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.

Transposase-Enabled CLD: From Transfection To High Titer With Ease

Gain insight into the benefits of a next-generation CLD platform that delivers consistent quality, scalable performance and flexible expression solutions tailored to the demands of complex molecules.

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Join Outsourced Pharma Online on September 3rd at 2pm ET for a virtual panel discussion on overcoming difficulties outsourcing development and manufacturing, how does a biopharma organization (of any size) handle a multi-CDMO coordination. Registration is free for this digital event.

SOLUTIONS

Flexible Manufacturing Solutions, Services To Meet Evolving Industry Needs

Review our full range of support services to streamline manufacturing processes through to the commercialization of aseptic and lyophilized products.

Automated PUPSIT And Sterile Filtration With Enhanced Product Recovery

This drug product filtration system operates using configurable recipe-controlled phases to automatically perform terminal sterilization prior to filling with maximum product recovery using standard flow kits.

Trusted End-To-End CDMO Partner For Your Journey

We now serve more than half of the world’s leading biopharmaceutical companies, sharing their mission to expedite patient access to life-saving biologics.

Advanced Drug Delivery And Drug Device Combination Product Solutions

Our end-to-end injectable services, comprehensive approach, and dedication to excellence provide convenient, easy-to-use, patient-centric therapies.

Protein Analytics: Early Analytics Ensures Successful Research, Development

With a suite of analytical services and capabilities, we equip our clients with the insights and tools needed for successful biologics characterization and phase-appropriate process development.

Drug Product Manufacturing: Scaling Product From Bench To Market

Curia offers comprehensive development and manufacturing services to meet needs through the entire lifecycle of your sterile drug product. Leverage our in-depth expertise and capabilities at any scale.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

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