We aim to become the partner of choice for the development of Oligonucleotide API. With customer R&D activities at elevated level, we support early-stage projects with GMP capabilities, process and analytical development as well as regulatory support, building on our vast experience in Peptide API development and GMP manufacturing.
Our efforts to address the emerging customer needs in Oligonucleotides started in 2019. We already manufacture specialized modified oligonucleotides for clinical trials and commercial use. We see our OLIGO@POLYPEPTIDE™ initiative as highly synergistic to our peptides business, while recognizing the technical differences, particularly in the upstream manufacturing process. Our OLIGO@POLYPEPTIDE™ facilities are located in Torrance, California, where the development laboratories are in use and by the end of 2021 our pilot GMP facility will be operational. Our experts are keen to take you from early phases though to commercialization.
Our current development laboratories are equipped with several OP100 trains and our GMP Pilot plant will initially be equipped with several OP400 lines. Additional investment in both areas are planned as we gradually enhance our capabilities and capacity to meet the evolving needs of customers, many of which we already serve through our peptide business.
Trishul Shah – Director of Business Development and Head of North American Sales. Trishul is involved in industry peer groups such as the TIDES Advisory committee, Boulder Peptide Symposium Scientific Board, a member of the PolyPeptide Group’s Executive Strategic Team in the US and member of the Global Management Group at PolyPeptide.
Tim Culbreth – President – US Operations at PolyPeptide Group, responsible for the two US Sites: San Diego and Torrance. Tim Culbreth has been in the pharmaceutical industry for over 35 years. Tim has worked on multiple facility buildouts, expansions and new construction projects. Tim has also been part of start-up teams for a number of major selling drugs including: simvastatin, omeprazole and capecitabine.
Eran Benjamin – Global Director of Quality Control and Analytical Development, Eran worked for many years with Eli Lilly and Company in the development and commercialization of Insulins and peptide-based therapeutics, and was the Director of characterization science and small molecule analytical development
Kevin William Carter – Responsible for overall operations of the Oligo development and pilot plant areas. Trained synthetic organic chemist with radiochemistry professional experience. Five year of oligonucleotide experience in contract GMP manufacturing.
Arnold Kemp – Responsible for day to day operations in the pilot plant. Trained biochemist with over a decade of professional laboratory experience and two years of GMP oligo production management.
Katherine Wood– Katherine responsible for equipment installation and qualification. Trained biochemist with three years of industry experience in GMP analytical development, stability testing, and peptide manufacturing.
What are Oligonucleotides?
An oligo, or more specifically an oligonucleotide, is best described as a short molecular string consisting of building blocks identical or very similar to the building blocks found in naturally occurring RNA and DNA.
The oligo may be single stranded or double stranded depending of its intended use. There are several classes of oligos named after the intended mechanism of action, for example antisense oligonucleotides (ASO) and RNA interference oligonucleotides (RNAi).
The above-mentioned oligo building blocks consist of three elements: a nucleobase, a sugar and a phosphate. Any of these can be synthetically changed to create a modified oligo, and the changes ranges from a few points of changes to an entire structural element being changed.
Point of Contact: Trishul Shah, Director Business Development, Head of Sales, North America, Trishul.firstname.lastname@example.org