Sustained Release Gel Formulation
March 2nd 2023A long-acting injectable improves the patient’s experience by only requiring a once weekly, or monthly injection as opposed to a daily dosing regimen. The gel depot formulation is simple to manufacture, and easy to tune to the desired release duration and dose.
Developing Liquid Formulations for the Oral Dosing of Lipophilic Drugs
October 4th 2022Tuesday, October 4, 2022 at 11am CDT |12pm EDT | 9am PDT Is developing formulations of highly lipophilic compounds worth the effort? With today’s excipients and technologies, the answer is a definite yes. This presentation will showcase the issues presented by lipophilic compounds and ways to address them.
Peptide Formulation: Initial Clinical Development, Final Dosage Forms and Life Cycle Management
November 30th 2021**Tuesday, Nov. 30, 2021 at 2pm EST | 1pm CST | 11am PST*** Formulation options for peptides in early development versus strategies for final dosage for design, keeping all options open. Peptide formulation strategies for rapid entry to the clinic. *** On demand available after final airing until November 30, 2022.***
Challenges with Verification of Compendial Chromatographic Methods
May 27th 2021*Live: Thursday, May 27, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST* Compendial verification is a regulatory requirement. Often overlooked are the technical merits of a robust review of the written method and the value of demonstrating fit for purpose in your laboratory. Experts will share experiences gained over years of evaluating hundreds of methods to help you avoid similar obstacles and delays in your laboratory. *On Demand Until May 27, 2022*
Understanding Polymorphism to De-Risk Drug Development
September 29th 2020*** Live: Thursday, Oct. 15, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST *** Polymorph screening of small-molecule drug candidates enables rational selection of the proper solid form/polymorph for further development. Learn the elements and techniques of polymorph screening is and why performing it thoroughly will help de-risk drug development effort. ***On demand available after final airing until Oct. 15, 2021***
Extractables and Leachables of Biopharmaceutical Container Closure Systems
September 3rd 2020Learn how to navigate the regulatory requirements for extractables and leachables testing for new biologic drug products. Review the essential steps to for study design, extraction, analysis, and reporting of extractables and leachables data in this webcast. Live: Thursday, Sept. 24, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until Sept. 24, 2021
Gene Therapy Development: From Methods to GMP Testing
August 5th 2020The molecular complexity, size, and higher-order structure of gene therapies create a unique challenge for pharmaceutical development. This webcast will provide insights into characterizing viral and non-viral gene therapies to ensure quality. Live: Thursday, Aug. 20, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Aug. 20, 2021