Newsletter | November 25, 2025

11.25.25 -- Improving Sponsor–CMO Collaboration Around Digital Deviations

SPONSOR

Live Event: How Digital Tools Are Accelerating Biopharma Development

Register today for this digital event led by Bioprocess Online’s chief editor, Tyler Menichiello, features industry experts who will share for an engaging panel discussion on how companies are deploying advanced technologies and tools to accelerate biopharmaceutical development. This event is free to attend thanks to Cytiva.

FOCUS ON OUTSOURCING

How To Improve Sponsor–CMO Collaboration Around Digital Deviations

Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.

Quality And Regulatory Compliance In Fill-Finish

This resource provides a clear roadmap for delivering advanced sterile injectable therapies with confidence, meeting both regulatory demands and patient needs without compromise.

Challenges And Solutions For Viral Product Development, Manufacturing

To execute complex viral product manufacturing, a service provider needs expertise in adherent cell culture capabilities, cell line productivity, and the intricacies associated with these products.

Validation Provider Shortens The Path To Equipment Qualification

Learn about the partnership that enables Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

Why Cell And Gene CDMOs Benefit From Digitalization

Discover why digitization is crucial for cell and gene contract manufacturers by learning the various benefits digital transformation can offer such as efficiency, compliance, and innovation.

Mobilizing Science, Partnership, And Capability To Develop A Gene Therapy

Hear how one family, driven by urgency, partnered with AAV experts to develop a treatment for their daughter’s ultra-rare neurodegenerative disorder, NEDAMSS, in just 14 months.

Preclinical Development: A Successful Transition To cGMP Manufacturing

Explore the development steps that lead to an mRNA construct optimized for your requirements and that meets future-proof cGMP manufacturing requirements, thereby de-risking the development.

How Label-Free Nanoparticle Trapping Illuminates Biotech's Future

The ISABEL trap, which deploys interferometric scattering as a highly sensitive, fluorophore-label-free detection scheme, enables precise interpretation of the actions of complex biomolecular nanoparticles.

Accelerating Drug Development: Flexible And Fast DNA-To-IND Programs

Gain expert insights on how tailored approaches and innovative technologies enable fast and flexible development workflows, ultimately supporting rapid therapeutic breakthroughs.

Fab-Oligo Conjugation

Explore a platform process towards the production of Fab-siRNA conjugates that proves to be scalable and efficient. Find out more about how bioconjugation services can improve your discovery program.

Accelerating Rare Disease Treatments From Concept To Cure

Access a thorough investigation that delves into the critical aspects of expediting curative therapies, with a focus on the strategic role that CDMOs can play in this transformative journey.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics

Examine the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

Study Viral Infection In Resting Humans CD4+ T Cells With Synthetic sgRNAs

Discover how Synthego's proprietary synthetic sgRNA, combined with Lonza’s 4D-Nucleofector®, enabled highly efficient gene editing in resting human CD4+ T cells.

OUTSOURCING SOLUTIONS

Integrated ADC Offering: From Concept To Commercialization - Lonza

Achieve Your Sterile Injectables Commercialization Goals - Simtra BioPharma Solutions

Advanced iPSC Workflows: Accelerating Cell Therapy Development - Catalent

mRNA/LNP Development And Manufacturing Services - Lonza

Codex® HiCap RNA Polymerase - Aldevron

Drug Characterization And Release Testing Services - Mabion

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