Newsletter | February 9, 2026

02.09.26 -- The Quiet Case For Trusting CDMO Pricing

SPONSOR

Fireside Chat: Formulation & Delivery of Spray-Dried Biologics

Join our panel for a fireside chat about the formulation and delivery of spray-dried biologics across oral solids, nasal, pulmonary and injectable (high concentration and encapsulated biologics) dosage forms. Expert discussion around the benefits and applications of spray drying in the development and manufacture of biologics alongside excipient selection, development timelines, testing methods and GMP manufacture. Register Now.

INDUSTRY INSIGHTS

What To Expect From A Sterile Injectables CDMO

Sterile injectable manufacturing demands built‑in contamination control, monitoring, skilled personnel, and robust quality systems, far beyond sterility testing, to ensure reliable CDMO performance.

The Best CDMO Fit For Small Molecule, Sterile Injectable Fill/Finish

Comprehensive sterile injectable fill/finish capabilities can help accelerate development timelines and reduce overall costs. See flexible operational options and available capacity.

Considerations For Subcutaneous, Intramuscular Formulation Development

Explore the changing landscape of parenteral delivery, considering the pros and cons of intravenous, subcutaneous, and intramuscular formulations, and how new technologies are reshaping drug delivery.

FEATURED EDITORIAL

The Quiet Case For Trusting CDMO Pricing

“Given our industry, with so much forward risk, my overall philosophy is not to necessarily get stuck on pricing," says a commercially successful outsourcing veteran, although he quickly adds, “I don’t broadcast this externally, or even internally – quote me anonymously!" I did, and he proceeded to provide intriguing insight into working with CDMOs.

Facility Considerations When Retrofitting Legacy Sites For ADCs

Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.

INDUSTRY INSIGHTS CONTINUED

Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics

All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for evaluating and controlling Essential Drug Delivery Output (EDDO) requirements.

Prioritizing Data Security Through Digital Transformation

Integrating advanced digitalization solutions and prioritizing data security can accelerate drug development while reducing costs and ensuring consistency across a global network.

A Hybrid Approach For Optimizing Transient Protein Expression In CHO Cells

When choosing between protein expression formats such as transient versus stable pools, considerations include speed, cost, titre, and product quality.

Leveraging Bio-Functional Assays For Charged Variants Characterization

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

Managing Supply For Complex Biotherapeutics

Antibody-drug conjugates' manufacturing supply chain contains five different technologies with specific asset needs: monoclonal antibody, cytotoxic payload, linker, bioconjugation, and fill & finish.

Flexibility And Capability In Pre-Filled Syringes: The Future Of PFS

Outlined are the inherent benefits of PFS and how they relate to the delivery of drugs, how SARS-CoV-2 could be fueling an explosive increase in PFS demand, and how a partnership with a CDMO is key.

Framework To Deliver Standardized, Reliable Biomanufacturing Facilities

Standardized, continuously optimized facility design enables efficient and reliable biomanufacturing that improves quality, accelerates timelines, and ensures consistent performance across sites.

PAT Monitoring And Control Roadmap

Learn how to implement PAT effectively with a roadmap that covers techniques, validation, data integrity, and lifecycle strategies to help teams improve quality, control, and productivity.

SPONSOR

AI Innovation in Drug Development

AI is shifting from experimentation to execution in drug development. This OPCU special edition explores where AI delivers value today—across discovery, CMC, and quality—and how CDMOs and sponsors can collaborate to reduce risk, improve quality, and accelerate timelines, with practical guidance on readiness, regulatory considerations, and sponsor expectations.

SOLUTIONS

Tailored CDMO Solutions With Unmatched Quality

Partner with a premier global CDMO to move from discovery to commercialization faster, powered by dual-site manufacturing, 20+ years of expertise, and advanced ADC conjugation.

A/L/P Assembly, Label And Packaging

Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.

From Concept To Market: Mammalian Protein Development And Manufacturing

With proven expertise in process development, optimization, and CGMP manufacturing, Avid offers end-to-end CDMO solutions backed by flexible capacity designed to scale with program needs.

Comprehensive Manufacturing Solutions Backed By Global Expertise

Gain insight into a CDMO with global, end-to-end mammalian manufacturing solutions, proven expertise, flexible capacity, and a strong track record in regulatory compliance that can support your company.

Bridging The Gaps: Enhancing First And Last Mile Resilience

Designed as a dedicated, short-range logistics service for the life sciences, this solution reinforces chain of custody, ensures near real-time visibility, and preserves product integrity from start to finish.

Monoclonal Antibody Development, The Way It's Meant To Be

Leverage development strategies and enable an optimized process for mAb development and manufacturing, efficiency, and speed with quality, and high titers with lower-cost workflows.

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.

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