Shinichiro Fujiie, President and CEOEstablished in 2017 and commencing operations in 2019, PeptiStar breathes fresh air into the pharmaceutical landscape by specializing in peptide and oligonucleotide therapies. These cutting-edge treatments represent the next innovation wave in medicine, offering the potential to treat diseases resistant to traditional small-molecule drugs and large biologics.
Its core competency supports the research, development and manufacturing of peptide therapeutics from early-stage discovery to commercial-scale production. This end-to-end capability sets PeptiStar apart, allowing partnerships with clients throughout the drug development lifecycle.
“Our facilities are equipped to handle the peptide, oligonucleotide synthesis and conjugation complexities, providing end-to-end solutions. This is crucial in a field where such expertise is scarce. Yet, the demand is rapidly increasing, particularly for advanced therapeutics that address previously unmet medical needs,” says Shinichiro Fujiie, president and CEO.
It’s an important reason why PeptiStar quickly captured a dominant position in its home market of Japan, while serving a distinct and growing client base of 47 companies.
With such capabilities, PeptiStar is poised to make a significant mark in the U.S. among industry giants like Pfizer, Lilly and GSK, as well as emerging startups.
A Glimpse into its Capabilities...
Inside PeptiStar’s reactor facility for peptide APIs, customers will find reactors up to 300 liters, producing around 10 kg per batch.
PeptiStar stays ahead of the curve with its twin-column chromatography technology, developed with top Japanese maker YMC, which can be used in GMP production on milligram to kilogram scales, giving PeptiStar a market edge. Its technology portfolio reads.
like a who’s who of industry leaders, with solid-phase peptide synthesis (SPPS) using microwave technology from Microwave Chemical and PeptiDream’s SPPS technology, liquid-phase peptide synthesis using Sekisui Medical’s technology, Nissan Chemical and PeptiDream LPPS technology, analysis technologies from DAICEL and SHIMADZU and concentration/lyophilization technologies developed in collaboration with Japanese top makers AsahiKASEI and Kobelco Eco-Solutions.
But it’s not just about technology; it’s about the people behind it. “Our joint venture leverages shareholder expertise, resulting in distinct capabilities,” explains Yoshitaka Nemoto, corporate officer and head of R&D. “For example, using continuous column chromatography technology, we achieved an 83 percent recovery rate for a model peptide API, compared to 30 percent with the traditional method, enabling us to offer competitive prices.”
PeptiStar’s experience spans distinct peptide synthesis, including long-chain peptides over 100 amino acids, branched peptides, various cyclic peptides and peptide-oligonucleotide conjugates. It also produces oligonucleotides, including long-chain nucleotides over 100mers with single-guide RNA (sgRNA) and multiple oligonucleotide type products like deoxyribonucleic acid (DNA), ribonucleic acid (RNA), small interfering RNA (siRNA), phosphorodiamidate morpholino oligomer (PMO) and all phosphorothioate (PS) forms. It can even conjugate oligonucleotides with peptides, polyethylene glycol (PEG) and fatty acids.
Our facilities are equipped to handle the peptide, oligonucleotide synthesis and conjugation complexities, providing end-to-end solutions. This is crucial in a field where such expertise is scarce. Yet, the demand is rapidly increasing, particularly for advanced therapeutics that address previously unmet medical needs
Regarding timelines, PeptiStar is in a league of its own. It dispatches 500 milligrams within one month from the order and 50g scale products within two months. Non-GMP production with quantity over 1kg can dispatch products within four months and GMP production with quantity over 1kg can be done within six months including raw material procurement, QC testing and QA review. And if that’s not fast enough, PeptiStar can shorten lead times further by using full-time shifts upon customer request.
“Our goal is to be a trusted partner for pharmaceutical companies, supporting them in bringing innovative peptide and oligonucleotide therapies to patients faster and more efficiently,” says Yasumasa Watanabe, corporate officer and head of the corporate strategic department. “With our expertise and advanced technologies, we are well-positioned to significantly impact the pharmaceutical industry.”
As PeptiStar expands globally, it maintains strong quality and compliance commitments. It has passed audits from domestic and international customers, inspections from the Japanese regulatory authority, PMDA and a qualified person audit for EU compliance, adhering to global GMP standards.
These competencies are just the beginning of PeptiStar’s journey. By prioritizing innovation, adaptability and excellence, PeptiStar transforms the landscape of peptide and oligonucleotide therapies, offering new hope for patients worldwide.
