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

Four experts share how scale-up, regulatory expectations, demand forecasting, and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.

Despite challenges with mammalian host cell line diversity, the following mitigation strategies were able to drive efficiency and reproducibility, maximizing cell growth and product quality.

Medical device companies must meet the demand plan for their devices while managing production costs. Gain valuable insights for scaling up production capabilities efficiently and cost-effectively.

The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

The delicate balance between maximizing product yield, ensuring consistent quality, and navigating the complexities of regulatory compliance demands innovative solutions.

CEO Kenneth Bilenberg discusses building a CDMO's success on trust, reliability, and true partnership. The path focuses on agility to support biologics growth and the reshoring of U.S. manufacturing.

The dynamic growth and pace of change observed in novel mAb formats and cell and gene therapies emphasizes that biomanufacturing innovation is essential to deliver scale, speed, and sustainability.

Uncover how an innovative titerless baculovirus platform accelerates protein manufacturing with enhanced scalability, reproducibility, and long-term virus stability for cutting-edge biologics production.

Discover how the team was able to expedite the conjugation of an oligonucleotide-monoclonal antibody (oligo-mAb) program leveraging experience in chromatography.

Since the development of vaccines comprised of inactive or attenuated pathogens, there has been a drive to produce safer formulations utilizing known and well-characterized components.

Learn how partnering with a trusted CMO to navigate the complexities of sterile injectable manufacturing can ensure your life-changing therapies reach patients safely, efficiently, and at the highest quality.

Consider an approach where modular N-1 perfusion strategies shorten seed train timelines and reduces facility strain — enabling upstream processes that scale for commercial manufacturing.

Accelerate your biopharma journey with a comprehensive service portfolio designed to speed development, reduce costs, and minimize risk from molecule to market.

Rapidly execute multiple projects from our state-of-the-art cGMP facilities while ensuring full process and product compliance at all stages of research, development and commercial manufacturing.

See how this chemical structure enhances the solubility, stability, and bioavailability of small molecule drugs and complex biologics, making it an indispensable tool in pharmaceutical development.

Hear from Evan Pasenello, Head of Commercial Services, about how Resilience can support large molecule programs from early phase through clinical and commercial manufacturing.

Using our proprietary platforms, we design constructs optimized to express in your system, whether that's a single gene in E. coli, a metabolic pathway in yeast or a complex bispecific antibody.