02.11.25 -- It's Partly Personal (Medicine): In 10 Years Outsourcing At $315 Billion

Join us on February 20th to learn how to overcome manufacturing and regulatory challenges in cell and gene therapy by developing robust CMC strategies, employing Quality by Design, and implementing phase-appropriate GMP processes. This webinar is ideal for small biopharma companies and institutions seeking to bridge research and commercial development effectively. Click here to learn more.

Cell and gene therapies have unique complexities and challenges. A manufacturing execution system (MES) can expedite your processes and get your product to commercialization faster.

Explore our comprehensive methods for assessing DNA purity and integrity in AAV products to ensure the highest quality gene therapies for your patients.

Manufacturing mRNA products is a complex and challenging process that requires careful consideration at each stage. Learn more about the challenges and intricacies involved.

Plan early and align research, development, and commercial priorities to ensure a seamless transition from clinical development to scalable, cost-efficient commercialization.

Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

Gain insight into how small variations in the apheresis process can lead to significant differences in the cellular products, ultimately influencing therapy effectiveness.

Build a reliable, de-risked path to the clinic while avoiding unforeseen costs and compliance-related delays with advice from Suparna Sanyal, PhD, Head of Viral Vectors Commercial Development.

As mRNA medicine continues to evolve, understand how trusted manufacturing partners will continue to play a pivotal role in translating innovative concepts into clinical reality.

We encourage further investigation into the identified pathways to optimize rAAV production processes, enhancing yields and vector quality for more scalable and effective gene therapies.

As sponsors strive to deliver therapies with increasing efficiency, CDMOs are poised to remain vital, offering specialized expertise, accelerated timelines, cost efficiency, and risk mitigation.

Discover how cutting-edge logistics innovations are redefining gene therapy transportation to ensure safety, efficiency, and sustainability.

Today, plasmid DNA plays a critical role in the production of next-generation cell and gene therapies and vaccines. With our expertise, we have helped facilitate the advance of these important therapeutics.

The industrialization of CGTs will require deep appreciation of the biological roles of key components, including advanced viral vector production technologies and adoption of allogeneic cell therapies.

Join Outsourced Pharma Live for an in-depth examination on how the BIOSECURE Act is impacting risk management, compliance, and the future of global outsourcing in drug development and manufacturing. Our supply-chain experts will provide actionable insights to ensure your outsourcing strategies align with the greater legal, regulatory and geopolitical environment. Secure your free registration today!

Focusing on biologics, vaccines, nucleic acids, and gene therapy, our Boston facility is now a commercially licensed site boasting a 10x 2,000L drug substance manufacturing capacity.

Leverage POSTmark to streamline your path from R&D to cGMP-scale AAV production, reducing time, costs, and risks with a fully mirrored, scalable platform.

Our Manufacturing, Science, And Technologies (MS&T) team serves as a hands-on liaison between our partners and process development and manufacturing teams, working to advance therapies.

We offer comprehensive technology platforms and services to expedite the discovery, development, testing, manufacturing, and commercialization of clients' pipeline.

Leveraging more than 15 years in the field, we provide custom development and manufacturing of AAV vectors for gene therapy as a full-service concept-to-commercialization cGMP CDMO.

Consider how our end-to-end, customer-centric CDMO services have been successful in helping to bring more breakthrough treatments to patients.