#Taiwan #Taipei #Pharmaceutical Manufacturing #SPERA PHARMA #Mycenax Biotech

Strategic Alliance to Optimize Pharmaceutical Manufacturing

In a significant move to enhance the landscape of pharmaceutical development, Mycenax Biotech Inc., a renowned contract development and manufacturing organization (CDMO) based in Taiwan, has established a strategic alliance with SPERA PHARMA Inc., a Japanese expert in chemistry, manufacturing, and controls (CMC) for pharmaceuticals. This collaboration seeks to combine the strengths of both organizations to provide comprehensive solutions for conjugated antibody-drug (ADC) services and bioconjugates, covering processes from linker/payload synthesis to drug substance production, formulation, and aseptic filling and packaging operations.

Accelerating Market Entry for Biopharmaceuticals

The primary goal of this partnership is to accelerate the time-to-market for biopharmaceutical companies by providing an integrated and cost-effective platform for the development and manufacturing of ADCs. By leveraging Mycenax's extensive capabilities in end-to-end biologics and the CMC expertise of SPERA PHARMA and its partner Krisan Biotech, the alliance offers a unique solution tailored to the growing demands of international clients.

Mycenax has established itself as a global leader in biologics, with international regulatory agencies such as the EMA, PMDA, and Health Canada endorsing its operations. The company's strategic partnership with Krisan Biotech, initiated in 2022, has further broadened its next-generation technology platform specifically catering to ADCs. Together with SPERA PHARMA, this collaboration is positioned to deliver an unmatched level of speed and technical excellence to clients worldwide.

SPERA PHARMA: A Leader in CMC Services

Founded in 2017 in Osaka, SPERA PHARMA has built a reputation as a premier CDMO, specializing in CMC. The organization excels in process chemistry, formulation development, analytical sciences, and GMP-compliant aseptic manufacturing. With an experienced team of researchers, SPERA PHARMA supports pharmaceutical development across all phases, from initial research through to regulatory approval. Clients appreciate SPERA PHARMA's commitment to providing flexible support and comprehensive CMC solutions.

The Future of Pharmaceutical Manufacturing

The partnership between Mycenax and SPERA PHARMA marks a pivotal moment for pharmaceutical manufacturing services. By offering a full-range development and manufacturing solution, they enable developers of ADCs globally to benefit from unprecedented speed, flexibility, and technical excellence. This alliance not only enhances operational efficiencies but also reinforces both companies’ commitment to advancing the biopharmaceutical industry.

About Mycenax

Mycenax is a CDMO headquartered in Taiwan, offering integrated solutions for the production of biologics, from process development to GMP-compliant manufacturing. With two GMP-compliant production sites and a strong partnership with Krisan Biotech, Mycenax is dedicated to advancing and producing therapeutic ADCs for the global market. For more information, visit Mycenax's official website.

About SPERA PHARMA

SPERA PHARMA specializes in CMC services, focusing on process chemistry, formulation development, and experimental medicine manufacturing under GMP standards. Since its establishment, it has become a trusted partner for international clients looking for comprehensive CMC solutions. To learn more about SPERA PHARMA, check out their website at spera-pharma.co.jp/en.