Pace Analytical Life Sciences

Articles

How to Craft a Successful Orphan Drug Designation

FDA Orphan Drug Designation

Oligonucleotides are a class of biotherapeutics presenting complex challenges in the development and commercialization of gene therapies. Download our paper and learn how to move your project forward.

Gene Therapy Development: Pathway to Commercialization

Learn more about maximizing long-acting parenteral formulations using nanoparticles, microspheres and in-situ forming gels.

https://www.pharmtech.com/pt_w/advanced-methodology

This discussion will review the practical aspects of parenteral formulations containing the biodegradable polymer, poly(lactic-co-glycolic acid), or PLGA. Learn more about degradation and diffusion-based kinetics that are key to designed release profiles of hydrophobic and hydrophilic drugs. Various parenteral formulations such as nanoparticles, microparticles/spheres and in-situ forming gels and their preparations/characterizations will also be discussed.


Attendees will obtain a greater understanding of:

The physiochemical properties of poly(lactic-co-glycolic acid).

Proper selection of an optimal formulation based on desired release kinetics.

Production and characterization of key parenteral formulations for short- and long-acting release.

Research and Development (R&D) Scientists

graduated with his BS in Chemistry from UC Berkeley, and following completion, he moved on to the UC Davis for his Ph.D. in Physical Chemistry. His research was focused on drug delivery, such as long-acting injectables and dry-powder inhalables. He is the author of numerous scientific publications and patents. He now works at Pace® Life Sciences, where he continues to develop complex formulations and analytical methodology for a wide range of applications.

Webcasts

Webinar Date/Time: Wed, Jun 21, 2023 2:00 PM EDT

Advanced Methodology of Poly(lactic-co-glycolic acid)-based Parenteral Formulations

This webinar provides an insight into how a robust LC-MS/MS method development can be performed ensuring optimal method sensitivity to detect residual analytes.

https://www.pharmtech.com/pt_w/bioanalytical

Understanding biodistribution is critical for evaluating the bioequivalence, bioavailability, and toxicity of a drug substance 

. Residual drug substances or excipients are analyzed in various biological matrices, such as blood, plasma, serum, and tissues. The choice of matrix is mainly dependent on the route of administration. This webinar will provide some insights into:

Approaches taken during LC-MS/MS method development to ensure good method sensitivity

Optimization of sample preparation with an emphasis on protein precipitation technique

Ensuring method robustness before moving to validation

Learn the process of LC-MS/MS method development.

Learn the different sample preparation techniques used to deal with challenging biological matrices to attain target method sensitivity.

Learn how to ensure method robustness with a focus on method validation.


Scientist III/Group Leader
Pace® Life Sciences

Uday Velagapudi is a Scientist III/Group Leader of Pharmaceutical Sciences at Pace® Life Sciences, an integrated CMC drug product development contract research organization. Uday is an SME focusing on method development for bioanalytical quantitation, small molecule and metabolite characterization, protein characterization, and host-cell protein analysis using low- and high-resolution LC-MS systems. Uday has authored or co-authored eight publications in reputable journals, such as Science and Journal of Medicinal Chemistry, and received his Ph.D. in Medicinal and Pharmaceutical Chemistry from St. John’s University in New York.

Webinar Date/Time: Wed, May 24, 2023 2:00 PM EDT


Bioanalytical Method Development For Lipids in LNP by LC-MS/MS

Peptide modification via salts is a way to change properties of the API to make it more advantageous to the desired release profile.


Peptide Salt Selection & Characterization

A 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.