05.24.23 -- Decline In Cell And Gene Therapy Outsourcing?

Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

Improving your ADC’s chance of clinical success requires an understanding of what potential obstacles lie ahead and what capabilities and expertise are necessary to overcome them.

The introduction of novel solutions to facilitate adherence can support decentralized trials and mitigate potential concerns surrounding reduced patient-physician touchpoints.

With increasing molecule complexity posing growing challenges for formulation and manufacture, oral solids specialists require extensive expertise and cross-team collaboration to ensure project success.

Working with a CDMO that can impart extensive expertise to the numerous methods of downstream drug substance manufacturing ultimately can help you achieve the most positive outcomes for your process.

The accuracy, robustness, and completeness of the technical package an organization submits to its development and/or manufacturing partner is critical to meeting fill project timelines.

As you aim to reduce costs and ensure on-time delivery, discover the opportunities for drug formulation and commercial supply that can advance your therapy to the clinic and beyond.

Understand high titer expression of Fc-fusion proteins using the Apollo X platform coupled with integrated quality assessments, enhancing support for clients through the predicted growth in Fc-fusion clinical applications.

Explore current and emerging technologies to optimize mRNA manufacturing, especially when considering commercial production and the validation of processes in a cGMP environment.

Driven by advances in technology and increased acceptance of telehealth, see how digital medicines and DTx are poised to become an integral part of the healthcare model.

In a recent episode of Business of Biotech, Vaxxinity's Mei Mei Hu explored how traditional vaccines and biologic therapies are converging to improve access to treatment on a global scale.

A number of risk mitigation strategies related to the materials used to produce viral vectors can be employed to help accelerate progress toward commercialization of remarkable therapeutics.

Streamline the downstream process using variable pathlength technology to determine the DBC of affinity chromatography resins to produce reliable data more effectively and efficiently.

The stability challenges of many biologics require lyophilization to improve product stability, increasing the demand for CDMOs with a high level of expertise and scalable development and manufacturing solutions.

Autologous immunotherapies have evolved to provide breakthrough treatments, but complexity of the production process often results in extended timelines and high manufacturing costs.

Hear from site leaders and virtually tour the process and analytical development laboratory and GMP manufacturing facility, which includes four additional 2,000-liter single-use bioreactors.