Newsletter | December 22, 2025

12.22.25 -- Cell & Gene Therapy Outsourcing's New Paradigm

SPONSOR

Improving Methodologies For iPSC Manufacturing & Differentiation

Induced pluripotent stem cells (iPSCs) represent one of the most exciting breakthroughs in modern biotechnology, offering unprecedented opportunities for advancing regenerative medicine and cell-based therapies. Realizing the therapeutic promise of iPSCs is far from straightforward. Next-generation workflows are being developed to streamline iPSC manufacturing, enhance differentiation strategies, and enable pharmaceutical innovators to overcome the hurdles of scalability and consistency. Learn more now.

FOCUS ON OUTSOURCING

Cell & Gene Therapy Outsourcing's New Paradigm

The industry has flipped from scarcity to surplus, and sponsors now have leverage to set terms, not take numbers.

IND-Enabling Programs For Adoptive Cell Therapies

Accelerating the development of adoptive cell therapies through robust preclinical strategies and regulatory pathways is crucial to bringing these life-saving treatments to patients in need.

Overcoming Limits In LVV Titer Measurement

Learn how a platform streamlines LVV titer measurement, offering a faster and more efficient alternative to traditional methods and addressing key process development challenges.

Screening T7 Polymerases To Optimize xRNA Yield And Quality

Discover how the evolution of T7 polymerase is optimizing in vitro transcription for RNA therapeutics. See how to balance performance, cost, and supply to make smart choices for your xRNA manufacturing.

Hidden Risks In Your Supply Chain: Regulatory Support Can Save Your CGT

Unvalidated shipping lanes and incomplete documentation can cause regulatory delays. Proactive qualification and risk assessments are vital for compliance and safeguarding product integrity.

AAV Viral Titering Using Nanoplate-Based Digital PCR

Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.

Understanding FDA Calibration Requirements And Reducing Risks

Become equipped with the tools and strategies needed to strengthen your calibration efforts and better position your organization for success in regulatory audits.

Boosting CMC Regulatory Efficiency In Gene Therapy

Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

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.

The Strategic Benefits Of Isolator Lines In Manufacturing

Assimilate how high-speed isolator lines enable sterile, scalable manufacturing for complex biologics and injectables with unmatched efficiency and product integrity.

Leveraging Technology For Rapid Clinical Material Delivery

Explore how one family's collaboration with a specialized CDMO enabled the rapid development of a life-saving gene therapy for their daughter diagnosed with an ultra-rare disease.

OUTSOURCING SOLUTIONS

The Future Of Lentiviral Vector Innovation And Access - Vector BioMed

Capacity Update: Large Molecule - 3PBIOVIAN

Gene Therapy, Oncolytic Viruses, Viral Vaccines CDMO Services - FUJIFILM Biotechnologies

Translating Groundbreaking Research Into Life-Changing Therapies - Landmark Bio

UpTempoâ„  AAV Platform Process - Catalent

Connect With Cell & Gene: