Wakefield, MA – June 16, 2018 – Protein Dynamic Solutions LLC (PDS), developer of platforms for biopharmaceutical critical quality attribute (CQA) and biosimilar assessment,has recently established a new head office, as well as research and operations, in Wakefield, Massachusetts.
Founded in Puerto Rico by veterans of the biopharmaceutical industry, PDS is a provider of tools for high-throughput developability and comparability (HT-DCA) testing of therapeutic proteins. Their novel, array-based platforms incorporate bench-top laser microscopes and novel high-throughput sample handling and analysis technologies to provide visual and hyper-spectral analyses of biotherapeutics; thus, informing the structures, mechanisms and amino acid residues involved in protein stability, aggregation and change.
“We are very excited to establish a presence in the Boston biotechnology hub,” said Belinda Pastrana, Founder and CEO. “We have worked in, and supported, global biopharma companies for many years and it’s invigorating to now have a home at the source of many of the innovations in our industry. We are delighted to be geographically co-located with our key clients and partners and to play an intimate role in their go-forward pipeline strategies.”
PDS provides a number of solutions for protein characterization and has developed enabling capabilities for CQA assessment and for batch-to-batch comparability during process-, site- or manufacturing changes. Their platforms enable equivalence testing of biosimilars with innovator products in real-time under the same formulations and stressors, providing statistically robust data to establish analytical biosimilarity.
“HT-DCA provides a unique and higher-order structure characterization of drug molecules and provides crucial molecular dynamic information forin silico simulations and protein design. The platform can be used by biosimilar manufacturers to demonstrate similarity or by innovator organizations to provide valuable added patent protection,” said William Lockwood Benet, an established investor supporting biologics and pharma R&D decision analysis rationalization, a member of the SBIR Advisory Committee of the US National Science Foundation (NSF) and Founder/CFO of PDS.
PDS began as an NSF SBIR Phase II grantee and is funded by experienced institutional and individual investors who focus specifically on the life science tools area. It has completed validations of the HT-DCA platform with global partners including the US National Cancer Institute and individual stakeholders using molecules as diverse as the NIST reference mAb and proprietary urology candidates.
“We are excited to be offering Early Access to HT-DCA technology for a number of global biopharma and CRO companies,” said Dr. Pastrana. “We welcome contact from anyone who is interested in having their protein samples evaluated or seeing a demonstration of the system.”
About Protein Dynamic Solutions (PDS):
Headquartered in Wakefield, MA, and founded in the US bioprocessing hub of Puerto Rico, PDS develops breakthrough tools for bioanalysis of therapeutic candidates. Founder, Belinda Pastrana, is a renowned expert in protein conformation, having lectured over the world and trained a generation of analytical and physical chemists to work in the biologics industry. Her team at PDS include scientists and regulatory experts formerly from Eli Lilly, Abbvie and Johnson and Johnson as well as a financial and commercialization team with a strong track record for realization of cutting-edge technologies for the biopharma space. Board members and advisors include veterans of biopharma and the life sciences.
PDS’ flagship product is a high-throughput developability and comparability assessment tool – HT-DCA - which utilizes a unique combination of microscopy and molecular spectroscopy to provide array-based visualization and analysis of protein drug formulations.
Protein Dynamic Solutions, LLC
11 Audubon Road Wakefield, MA 01880-1256
Tel. +1 (978) 594-6955