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

Mycenax and SPERA PHARMA Join Forces for Advanced ADC Solutions

In a strategic move that promises to reshape the landscape of drug manufacturing, Mycenax Biotech Inc., a leading biologics contract development and manufacturing organization (CDMO) based in Taiwan, has announced its partnership with SPERA PHARMA Inc., a Japan-based expert in pharmaceutical Chemistry, Manufacturing, and Controls (CMC). This collaboration aims to streamline the manufacturing process for antibody-drug conjugates (ADCs) and bioconjugates, addressing a significant need in the biopharmaceutical industry.

The alliance capitalizes on the complementary strengths of both companies. Mycenax Biotech is renowned for its comprehensive biologics solutions, while SPERA PHARMA brings in-depth expertise in CMC, focusing on linker and payload synthesis, drug substance production, formulation, and aseptic fill-finish processes. This combination creates a robust platform, delivering an all-inclusive solution tailored to meet the increasing demand for ADC development services.

One of the primary goals of this partnership is to expedite the time-to-market for biopharmaceutical companies. The integrated ADC development and manufacturing platform will not only enhance efficiency but also provide cost-effective options for clients. By leveraging Mycenax's end-to-end capabilities alongside SPERA PHARMA's high-potency fill-finish services, the partnership ensures that global clients receive top-notch solutions that cater to their specific needs.

SPERA PHARMA, which was established in 2017 as a spin-off from Takeda Pharmaceutical Company’s CMC Research Division, is celebrated for its vast experience in complex drug development. The company's portfolio includes expertise in process chemistry, formulation, analytical development, and GMP-compliant aseptic manufacturing—hallmarks of a trusted entity within Japan’s esteemed pharmaceutical framework. As one of Japan's leading CDMOs, SPERA PHARMA has established itself as a reliable partner for global enterprises, known for its technical excellence and integrated CMC solutions.

Mycenax itself holds a reputable position globally, audited by major international regulatory bodies such as the EMA, PMDA, and Health Canada. Through its 2022 strategic partnership with KriSan Biotech, Mycenax has needed to broaden its ADC technology platform, effectively positioning it to support the growing market demands.

The union of Mycenax and SPERA PHARMA signifies a significant evolution in the ADC manufacturing sector. Clients now have access to a comprehensive suite of development and manufacturing services that prioritize speed, flexibility, and technical proficiency. This collaborative approach not only strengthens the value proposition for biopharmaceutical developers but also sets new standards in the industry.

About the Companies

SPERA PHARMA: Founded in July 2017 in Osaka, Japan, SPERA PHARMA specializes in Chemistry, Manufacturing, and Controls (CMC). It provides a wide range of services that cater to all phases of pharmaceutical development, from early-stage research to final regulatory approval. The company is dedicated to delivering flexible and comprehensive CMC solutions that satisfy the diverse requirements of global clients. To learn more, visit spera-pharma.co.jp/en.

Mycenax: Headquartered in Taiwan, Mycenax Biotech offers integrated biologics solutions spanning from process development to cGMP-compliant manufacturing. With two GMP-compliant facilities and a strong commitment to developing ADC therapeutics for the global market, Mycenax is a key player in the biopharmaceutical landscape. Further information can be found at mycenax.com.