Newsletter | April 30, 2026

04.30.26 -- Mapping Candel Therapeutics' Sprint To The BLA Finish Line

SPONSOR

How do your peers make process decisions that hold?

Join the Cytiva process development virtual summit (May 19–21, 2026) for practical protocols and decision frameworks on topics like analytics, intensification, purification, and scale-up. Learn the steps real PD teams take to avoid missed handoffs—so process strategy stands up through tech transfer and scale-up, without reversals or rework. Attend one talk or 20+ across three days. See full agenda.

FOCUS ON OUTSOURCING

Mapping Candel Therapeutics' Sprint To The BLA Finish Line

Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.

Developing New Medicines Through Artificial Intelligence

Embrace the future of drug development by leveraging AI and innovative protein synthesis technologies to accelerate the creation of effective therapies and transform patient outcomes.

Regulatory Considerations For First-Time Drug Developers

Navigate the challenging path from concept to clinical reality by partnering with an experienced CDMO that can provide the regulatory, clinical, and CMC expertise needed to move your therapeutic forward.

Strategies For Engineering Mammalian Cells

Using cells with a pre-engineered landing pad, we achieve inducible expression within just 4-6 weeks after donor plasmid creation, significantly reducing development time and effort.

Successful Completion Of The Project NaDiNa

Conducted alongside the Faculty of Medicine at Palacky University and supported by the Technology Agency of the Czech Republic, this project focused on translating research into a viable product.

Strategic Hiring For Scalable Success

Discover how a people-first talent strategy, purpose-driven culture, and cross-functional collaboration come together to support scalable growth and operational excellence in commercial manufacturing.

How To Avoid GMP Manufacturing Pitfalls

Common GMP pitfalls stem from poor scalability, late regulatory planning, weak tech transfer, unsuitable hosts, and inadequate quality systems, delaying biologics production timelines and budgets.

A Surprising Truth: CDMO Operations Should Be Boring

Operational excellence in drug manufacturing comes from predictability. Standardized, consistent processes reduce volatility and ensure steady, high‑quality progress.

Primary Normal Human Cells, Media: In Vivo Relevance. In Vitro Results.

Bridge the gap between in vitro research and human physiology by utilizing high-purity primary cells. Accessing diverse cell types ensures your gene therapy discovery remains biologically relevant.

The Continuation Of A Journey

See how one family managed to get an investigational gene replacement therapy manufactured and approved by the FDA so their daughter could be dosed just 14 months from her diagnosis.

Consistency Engineered For Animal‑Free Bioprocessing

Animal‑free soy‑based materials provide consistent molecular weight profiles, stable mineral levels, and controlled manufacturing to ensure reliable, reproducible bioprocessing performance.

OUTSOURCING SOLUTIONS

Extensive Quality Control Services - Argonaut Manufacturing Services

60-Seconds Of Science: Optimizing Complex Molecule Production - AGC Biologics

Tools For Developing Successful Biologics - Lonza

Microbial Services: Protein Manufacturing - 53Biologics

Our Global Manufacturing Network - Novartis Contract Manufacturing

Unlock Robust And Reliable Stability Data With The Right Partner - SGS

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