03.22.23 -- A Bridge To Capacity For Cell & Gene Industry

Successful tech transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and required regulatory filings.

A CDMO with in-house plasmid manufacturing capabilities can help companies accelerate timelines and ensure material availability, ultimately saving time and money throughout their product life cycle.

In this blog, experts discuss the common oral solid dose regulatory challenges you can anticipate, as well as how to plan for and address the hurdles you'll encounter.

How can drug sponsors and developers leverage these increasingly strategic commercial fill/finish partnerships? Explore tips on how to put programs on a firmer footing.

Discover the three major challenges cell and gene therapy manufacturers are facing today and experienced insights on how to overcome them.

Together, nuclear magnetic resonance (NMR) and MS analysis can definitively identify reference standards, active pharmaceutical ingredients (APIs), or final drug product composition.

This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes, from a mechanical testing perspective.

Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.

Understand how and when to plan your preclinical IND-enabling program as an integral part of meeting specific milestones necessary to timely and efficient IND submission.

Guidance for your plasmid DNA downstream process development, exploring cell harvest, lysis, neutralization and clarification, chromatographic purification, TFF, and sterile filtration unit operations.

Gain insights into a “simul-spray” process pioneered for combining small and large molecules into a single, atomized drug product for inhalation administration.

Explore flexible solutions that enable you to seamlessly guide your molecule through each early development phase with efficiency and speed.

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.

Experts share the necessary development and manufacturing considerations for a smooth tech transfer, exploring these challenges in depth and discussing the questions you should be asking your manufacturer.

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges.