02.23.23 -- 2023's Market Outlook For CGTs

Navigating an innovation’s critical path often begins with early-phase CDMO partnerships to build an integrated multifunctional project team with experience in the next-level biopharmaceutical space.

Leaning into a phased approach for plasmid grades to produce high-grade DNA and AAV under the same roof can provide a cost-effective jumpstart to process development and clinical manufacturing.

Speed plays an important role in gene therapy, and being first to market is essential for most gene therapies. Learn how you can benefit from an integrated approach.

While the successful completion of clinical trials can certainly help to invite and maintain funding, learn why those trials are not meaningful without an appropriately designed, manufactured, and controlled drug product.

Demand for single-use production tools, components, expertise, and capabilities continues to grow as innovative cell therapies evolve. However, concerns and misconceptions abound regarding single-use solutions.

Explore some of the clinical and technical challenges gene therapies face along with a comparison of gene therapy and mAbs, including launched asset success, phase-transition failure rates, and more.

Navigating an innovation’s critical path often begins with early-phase CDMO partnerships to build an integrated multifunctional project team with experience in the next-level biopharmaceutical space.

We analyze different approaches to building manufacturing capacity and assess the economic benefits of each approach.

Future-proofing products with strategies that reduce risk and timelines for later stages can be resource-intensive but add significant value. Explore the challenges encountered when progressing from development to clinic.

This e-book examines the rationale behind how CROs are selected, why they are retained, and why sponsors opt for one provider or outsourcing model versus another.

In this e-book, we outline several of the biological and manufacturing challenges for T cell therapies and highlight solutions that can help overcome these obstacles at each process stage.

Explore AAV-based gene therapy production to manage adherent and suspension processes and new approaches for creating large-scale AAV production that can meet any product specification.

Sernova Corp. is a clinical-stage regenerative therapies company currently focused on insulin-dependent diabetes. CEO and President Philip Toleikis, Ph.D., details the company's ongoing clinical trial to treat Type 1 diabetes (T1D) as well as the very real potential to progress from simply masking symptoms to having a functional cure for T1D. Toleikis also provides his take on the near-term future of regenerative medicine.

Walter Strapps, Ph.D., CEO of Carver Biosciences, states that when it comes to mRNA, the challenges associated with its delivery are anything but new. Indeed, Strapps explains that challenges have existed essentially since the dawn of nucleotide therapeutics in general. "There is a joke within the oligonucleotide field similar to the real estate industry in that in real estate it's location, location, location; for all nucleotides it's delivery, delivery, delivery," says Strapps.

Synthetic oligonucleotides are primarily used in therapeutics, as well as in diagnostic kits and PCR primers. This animation explains the repetitive four-step cycle of the oligonucleotide synthesis process.

When a new product, technology, or supplier is selected during the development and design phase of the biological manufacturing process, manufacturers must assess the supplier’s own supply chain and beyond.

This panel discussion highlights technical and regulatory hurdles associated with development and manufacturing steps and strategies and solutions to facilitate development through commercialization.

China now represents 60% of clinical development in CAR-T therapy development globally. What have we learned to date and where are future opportunities?