On November 15, 2024, Altruist Biologicstech, a leading domestic biopharmaceutical CDMO company, announced that its antibody conjugated drug (ADC) raw liquid and formulation production workshop (M3) located at its Hangzhou production base has officially started production! Becoming one of the few companies in China that can provide one-stop services from antibody and antibody conjugate drug stock solutions to formulations. This powerful production capacity will be able to meet the growing demand for ADC drugs in the market, accelerate the process of partner product launch, and enhance competitiveness.

On that day, Altruist Biologicstech Hangzhou Base welcomed a visiting delegation composed of outstanding founders and executives from the domestic biopharmaceutical industry, who visited the ADC commercial raw material and preparation workshop, as well as four 20000 liter antibody raw material factories and preparation factories.

The delegation expressed high interest and appreciation for the design layout, advanced hardware facilities, and automated production lines of the Hangzhou base. This reception fully showcased the international high standard and integrated ADC production workshop built by Altruist Biologicstech in accordance with the GMP and EHS processing requirements of China NMPA, US FDA, and European EMA for highly active substances, ensuring the provision of ADC products that meet global quality standards for customers.

A complete supply chain is the lifeblood of ADC production. Through its two major bases in Suzhou and Hangzhou, Altruist Biologicstech integrates the entire supply chain with small molecule supply in the surrounding Yangtze River Delta region, utilizing geographical advantages to build a fast response ADC industry core circle. The Suzhou base has a top-notch ADC process development laboratory and an innovative All DAR X2C technology platform, integrating multiple advanced technologies and Linker payloads based on multiple molecular types and mechanisms of action for different coupled drugs. It has comprehensive and mature coupling process development and optimization capabilities, and has achieved an ADC drug raw material process yield of>95%, with a target DAR ± 0.4, effectively ensuring the safety, effectiveness, and stability of drugs. The GMP pilot workshop at the Suzhou base can meet the production needs of clinical batch solutions of different scales.

As a GMP commercial production center for ADC drugs, the Hangzhou base is equipped with top-notch full line production equipment. Its sufficient production capacity can meet the demand for 100-500kg of raw liquid production and over 1 million bottles of formulation production per year, and has the ability to expand production capacity according to market demand. Altruist Biologicstech always provides support for ADC production, ensuring fast, low-cost, and high-quality delivery of customer product batches!

The Hangzhou ADC Commercial Plant is an important component of Altruist Biologicstech's future development. Since the Hangzhou base was officially put into operation on May 18, 2024, it has developed into an industrialized production and supply base that integrates the production of antibody and ADC drug raw materials and preparations! Highly integrated ADC drug full chain services, while creating production facilities and equipment with international standards and an international quality system, can provide high-quality, cost-effective, and multi-dimensional services for global partners.

As a leading domestic biopharmaceutical CDMO company, Altruist Biologicstech will continue to focus on the development and production of antibodies, fusion proteins, and ADC drugs in the future. We will continue to provide international standard one-stop biopharmaceutical development and production services to global customers, create a technology development platform with international quality, empower more customers, and benefit patients worldwide.

Source: https://pharm.jgvogel.cn/c1462890.shtml