As global business become increasingly multifaceted, pharmaceutical companies, start-ups, and academia are conducting research and development of new drugs in a variety of modalities※1 to meet unmet medical needs※2. With the increasing complexity of modalities, CDMO※3 are increasingly responsible for supporting the research and development of these new drugs by CMC※4 and stably manufacturing drugs for patients after launch. On the other hand, even on a global scale, there is only a limited number of CDMO with expertise in Peptides and Oligonucleotides, and there are cases where CMC development and manufacturing of clinical trial drug become bottlenecks to R&D of new drugs.

Under such circumstances, Peptistar was founded in 2017 as the first in Japan joint venture type CDMO for CMC development and manufacturing of Peptide APIs. As one of the members involved in the establishment of PeptiStar, I had the opportunity to establish the company from scratch, secure resources, HR, capital, funds, and networks, through manufacturing plant start up in 2019.

With the background for founding Peptistar, combined with our nimble and flexible management policies, Peptistar is not only in the Peptide API, but expanded into Oligonucleotides and Peptide-Drug Conjugate (PDC) business as well. We conduct a wide scope of activities in developing manufacturing process, from discovery to clinical development, analytical method development, and GMP※5 manufacturing of diverse types of compounds. We are now receiving inquiries and business from domestic and overseas clients. However, our efforts have not been an easy ride since the factory started operation. We faced multiple challenges during this time, but with the support and positive encouragements from our clients, shareholders, suppliers, employees and local community, we have been able to achieve our current status.

Peptistar is a company for stakeholders. As a successful business case study of establishing the plant from scratch, encouraging plant visits and promoting joint research activities through partnership, Peptistar continues to aim to take on the role as a hub CDMO for both domestic and overseas activities. After successful management by past presidents, Kiichi Kubota and Yutaka Kameyama, I now have the responsibilities as the new leader of Peptistar and I am determined to devote my life to the challenge of pioneering the future of the pharmaceutical industry together with our stakeholders.

I look forward to having your continued support.

PeptiStar Inc. President & CEO Shinichiro Fujiie (Ph.D)

*1 Modalities: A comprehensive word referring to a wide range of pharmaceutical discovery technologies and methodologies, including low-molecule pharmaceuticals, antibody pharmaceuticals, peptide pharmaceuticals, nucleic acid pharmaceuticals, and genetic treatment pharmaceuticals.
*2 Unmet medical needs: Medical needs to treat diseases that do not have effective treatment methods currently.
*3 CDMO: Contract Development and Manufacturing Organization. Organization or business entity that handles development of pharmaceuticals manufacturing process to clinical trial pharmaceuticals and commercial production under contract.
*4 CMC: Chemistry, Manufacturing and Control. The entire process necessary for the actual creation of pharmaceuticals, including API development, formulation development, quality assurance and quality control.
*5 GMP: Good Manufacturing Practice: Standards of manufacturing control and quality control for pharmaceuticals and quasi-drugs.