Drug Development

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

Webinar Date/Time: Session 1: Tuesday, February 28th , 2023 at 4pm GMT | 11am EDT | 5pm CEST Session 2: Wednesday, March 22nd, 2023 4:00pm GMT | 11:00 am EDT | 5:00 pm CEST Session 3: Thursday, April 20th, 2023 at 4 GMT | 11am EDT | 5pm CEST

Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.

Webinar Date/Time: Thu, Mar 30, 2023 11:00 AM EDT

Webinar Date/Time: Thu, Apr 6, 2023 11:00 AM EDT

In this episode, Rhonda Henry and Adam Mendizabal from Emmes discuss the role CROs play in cell and gene therapies undergoing clinical trials at all stages.

This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

Lipids aren’t the only important ingredients influencing stability and in vivo performance.

Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.

Webinar Date/Time: Friday, March 24, 2023 at 11am EST | 10am CST | 8am PST

Key challenges posed to autologous and allogeneic treatments could be resolved by in-vivo CAR-T gene therapies.

In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.

Webinar Date/Time: Wed, Mar 1, 2023 11:00 AM EST

In the coming year, pharmaceutical innovation will be fueled by key trends throughout the quality sector.

The COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.

Webinar Date/Time: Tue, Feb 28, 2023 2:00 PM EST

Webinar Date/Time: Thu, Feb 23, 2023 11:00 AM EST

Webinar Date/Time: Session 1: Evaluating the Best Formulations for Amorphous Solid Dispersions by Spray Drying: Tuesday, February 28th, 2023 4:00pm GMT | 11:00 am EDT | 5:00 pm CEST Session 2: ASDs by Spray Drying: Process Development & Scale-Up: Wednesday, March 22nd, 2023 at 4pm GMT | 11am EDT | 5pm CEST Session 3: Commercial Reality and Lifecycle Management of ASDs: Thursday, April 20th, 2023 at 4 GMT | 11am EDT | 5pm CEST

Webinar Date/Time: Tuesday, February 28th, 2023 at 11am EST | 8am PST | 4pm GMT | 5pm CET

Topical eye treatments can be beneficial for patients with a growing array of eye diseases, but only if taken appropriately.

Shifting guidance and the growing prominence of computer software assurance exemplify the state of computer software validation.

In vivo CAR-T gene therapies could resolve challenges faced by autologous and allogeneic treatments.

This new pioneering phase of mRNA is loaded with potential, but also obstacles and false dawns.

This event is now available on-demand!

The United States Patent and Trademark Office issued a Notice of Allowance for Zika vaccine patent to GeoVax.