Polymeric nanomedicines - Best practices to transition from an API into a final commercial product

Overview

PLG-based polymeric nanomedicines create new opportunities in therapeutic areas including immuno-oncology to improve parenteral administration, increase cellular uptake, enhance permeability, and illicit a stronger immune response. One key challenge obstructing PLA-based nanomedicines has been the need for commercially scalable GMP-compliant production systems and downstream processes that can enable full control over particle size distribution. A new process for the manufacturing of PLGA medicines at industrial scale is discussed. The use of PLA-PEG functional excipients to support the formation of nano-sized micelles for use with hydrophobic drugs, and increase circulation time in the bloodstream, is also reviewed. Evonik’s best-practices for purification, aseptic filling and drying will be presented.

Experts featuring this session

Dr. Andrea Engel
Global Head, Health Care Growth Projects
Evonik Health Care
Vita

Dr. Andrea Engel joined Evonik’s Health Care business line in 2013 and is currently Director Research & Development.

The team focuses on the development and analytics of new oral and parenteral platform technologies for the pharma and food industry as well as the development of cell culture media. One of the main research areas lies in the formulation and bioavailability enhancement of poorly bioavailable drugs and biopharmaceuticals.

Before taking over the current position she held a position as laboratory head and project manager in Innovation Management at Evonik where she has gained experience in developing complex oral and parenteral dosage forms and handling of highly potent active pharmaceutical ingredients.

She received her degree in pharmacy from the University of Frankfurt am Main and her Ph.D. in pharmaceutical technology and biopharmacy from the University of Muenster where she has specialized on the development of drug delivery systems based on bioabsorbable nanoparticles for cancer treatment.

Moreover, she has authored several research papers and patent applications.

Jerod Price
Director Drug Delivery Operations
Vita

Jerod Price joined Evonik Health Care in May 2020 as Director of Drug Delivery Manufacturing in Birmingham, Alabama, USA. He has more than 25 years of experience with Amgen, Inc. in operational roles in the US, Netherlands, and Ireland. These roles at Amgen included operational and supervisory roles including Plant Manager and Operations Improvement Director. He has extensive experience in pharmaceutical manufacturing, process development, technical transfer, clinical and commercial operations, including aseptic operations, lyophilization, filling, capping, packaging, and including capital projects, validation, FDA/EMEA regulatory inspections successes, and product launches and commercialization. Jerod also has a strong background in continuous improvement methodologies, operational excellence, six sigma, long range planning, and business processes, including workforce strategy and organizational design. Jerod has a B.A in Biological Sciences from the University of California Santa Cruz.