Newsletter | September 17, 2026

09.17.26 -- Don't Fear The Machine – A Biologist Explains AI In The BioPharma Industry

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Meet Coriolis Pharma at CPHI Worldwide in Milan to discuss in silico services, formulation development, GMP stability studies, release testing, and product characterization. Click here to learn more

INDUSTRY INSIGHTS

An Innovative, Modular Approach To Flexible Supply Chain Management

Learn how modular strategies, global coordination, and data-driven decisions help maintain continuity, compliance, and speed amid constant uncertainty.

An Insider's View On CDMO Services For Biologics

Maider Parikh, VP of Commercial Operations, reveals how top biopharma teams are tackling timeline pressure, regulatory complexity, and supply chain risk. Access the full Q&A to benchmark your approach.

The Impact Of A Unified Culture, From CDMO To Client To Patient

Operational excellence in drug manufacturing relies on a unified culture of integrity and proactive problem-solving. Aligned global teams strengthen the supply chain for reliable patient treatments.

FEATURED EDITORIAL

Don't Fear The Machine – A Biologist Explains AI In The BioPharma Industry

"I should have known," writes Chief Editor Louis Garguilo, "It takes an accomplished biologist to most effectively describe the significance of artificial intelligence in our outsourcing industry and how to put it to practical use." That professional is Damiano Dragone, Founder & Principal Advisor, Dragone Consulting, who built a career across pharmaceutical quality and data-driven quality environments within the biopharmaceutical industry, and was an early proponent of the promise of AI in development and manufacturing processes and facilities.

CDMO Winners And Losers: The Industry Shifts Shaping Outsourcing

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

INDUSTRY INSIGHTS CONTINUED

When Unexpected Particles Threaten Your Biologic

Particle contamination risks biologic safety. Advanced tools like Raman and SEM-EDS identify root causes fast to support robust, regulator-ready strategies that protect product quality.

Less Risk, More Speed -The New Blueprint For Bioconjugate Development

A fireside chat on how integrated development models reduce risk and accelerate bioconjugate timelines from discovery through GMP manufacturing.

Super Short Activated CAR-T Process

Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.

Antibody-Drug Conjugates: Next Generation Of Targeted Cancer Treatments

Manufacturing complex and highly potent ADC treatments presents unique challenges. Get an insider look at how these treatments make it from development to commercialization.

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

View 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 demand, and how a partnership is the key to success.

Confident Sialic Acid Identification With MS/MS

Traditional mass spectrometry left uncertainty around potentially immunogenic glycans. Assimilate how a biologics developer achieved regulatory-ready clarity.

Navigating Contamination Control For Ophthalmic Injectables

As the intravitreal therapy market grows and applicable regulations evolve, continued compliance demands technological savvy and rigorous contamination control.

What To Get Right Early In Subcutaneous Biologics Development

High-concentration biologics can face viscosity and aggregation challenges. Early modeling and targeted testing optimize formulations for stability, manufacturability, and delivery.

What Does a Friendly CDMO Expert Look Like?

Transparent, collaborative outsourcing reduces supply chain risk and protects IP. Open communication and proactive problem-solving keep development on track and speed commercialization.

Aligning Scientific Expertise To Accelerate Complex Biologics Programs

Complex biologics often outgrow traditional development platforms. Discover how an integrated development strategy can accelerate timelines while reducing risk.

Price Matters - Why Dash Believes In Transparency

Opaque pricing slows decisions and erodes trust. Transparency clarifies cost drivers, improves budgeting, enables confident sourcing, and strengthens long-term R&D partnerships.

Fast Path To Market: Going From GMP1 To PPQ In Just 12 Months

Uncover how focused optimization and coordinated execution helped overcome technical uncertainty and enable faster progression to market readiness.

Spotlight On Fremont: Biologics, Tailored By Mammalian Cell Culture Experts

Lilith Baczynski highlights how the Fremont site’s scale, flexibility, and expert teams support global mammalian biologics manufacturing.

SPONSOR

Smarter Lead Selection and Faster Representative Material for Early CMC Studies

Early CMC decisions have lasting implications for biologic development programs, influencing candidate selection, development timelines, and overall risk. Join us to explore emerging approaches to cell line development and early material generation that may help teams assess biologic candidates sooner, gain more representative data earlier in development, and make informed decisions that support efficient progression toward IND-enabling studies and clinical milestones. Learn more.

SOLUTIONS

Accelerating Complex Injectable Programs

Improve The Performance Of Your Biologic Formulations

Bringing Biologics To Market With Robust Analytical Science

Automated, Single-Use Systems For TFF At Multiple Scales

Compliant Storage For Chemicals, Process Liquids, And Buffers

Two Sites, One Standard of Excellence

Two Decades, One Focus: Sterile Manufacturing Excellence

Customized CMC Solutions

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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