Newsletter | March 16, 2026

03.16.26 -- Advising The Biotech C-Suite To Reconsider Quality

SPONSOR

Join our experienced panelists as they break down how to transform your CDMO partnerships from sources of stress into strategic assets. Register for free thanks to support from Simtra. More info here!

INDUSTRY INSIGHTS

Why CROs Need A New Operating System

See why building digital, automated infrastructure is essential, and better aligns CROs with today's speed, compliance, and innovation needs.

Mirror, Mirror Makes RNA-targeted Discovery Smarter

Examine a mirror‑image screening approach that eliminates DNA:RNA hybridization, revealing true binders and unlocking clearer, more productive DEL results for challenging RNA targets.

Qualities Of A CDMO Redefining Innovation

High-volume biologics and home-based care requires specialized expertise. Collaborative partnerships bridge the gap between complex drug-delivery requirements and successful commercial market entry.

FEATURED EDITORIAL

Advising The Biotech C-Suite To Reconsider Quality

“I assist C-suite executives to transfer quality from a painful cost center to a competitive asset." It's the type of bold statement that draws one's attention. Chief Editor Louis Garguilo asked David Grote on what his assertion means materially – and how that’s applied to working with CDMOs. Here's their discussion that focuses on a transformation that moves executives from regarding quality as ‘overhead’ to recognizing quality as “an operational element for business advantage.”

The Hidden Engineering Behind Successful Upstream Bioprocessing

In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.

INDUSTRY INSIGHTS CONTINUED

Essential Insights Into Linker Chemistry For ADCs

The linker is key to an ADC's success, influencing stability and targeted drug release. Explore the evolution of linker chemistry, from cleavable mechanisms to site-specific conjugation.

From Syringes To Wearables: Formulation's Impact

High‑concentration biologic formulations for prefilled syringes and on‑body devices enable easier self‑administration, reduce treatment burden, boost adherence, and address formulation challenges.

CDMO Partnerships: Why Speed And Flexibility Matter Now More Than Ever

As demand for GLP-1s and biologics accelerates and timelines compress, it's become more crucial that pharmaceutical companies stay competitive and bring therapies to market faster.

Interchangeability Assessment And Qualification Best Practice Guide

Review a structured framework for qualifying single-use component changes, with risk-based strategies, supplier insights, and practical tools to support resilient and compliant biomanufacturing.

Global Reach, Biotech Speed: Clinical Packaging, Labeling That Delivers

By integrating scalable operations, reliable supply chains, and deep regulatory expertise, biotech companies can eliminate bottlenecks, improve efficiency, and accelerate trial execution.

De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions

Discover an autoinjector platform that supports ANDA pathways with demonstrated usability and design alignment to help development teams reduce risk and move confidently toward regulatory submission.

Solid‑State HDX For ADC Stability

Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based antibody drug conjugates and enhance ADC development processes.

Scale-Up And BLA Planning For Microbial Biomanufacturing

Early planning for scale-up and biologics license application activities can maximize your chances of success by allowing sufficient time to develop launch options and prevent costly delays and setbacks.

Application Of Plant And Process Models

Assimilate how innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.

SOLUTIONS

Inside Our Advanced R&D Capabilities In The UK

Advanced experimentation, unified workflows, and continuous manufacturing are accelerating small‑molecule development, improving insight and creating more efficient paths from discovery to scale.

Large Molecule Capabilities In Network

Gain insight into our global manufacturing network, including information about the capabilities of each mammalian and microbial site within the network.

Improving CHO Cell Line Productivity

Advanced CHO cell line development methods can improve stability, yield, and overall biologic quality. These approaches also help resolve bottlenecks with support. 

Drug Product Manufacturing: Scaling Product From Bench To Market

We offer 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 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: