KangRi Bio: Building a High-Quality, End-to-End CDMO from IND to Commercial Aseptic Fill-Finish with One-Third Revenue from Overseas Orders

What Kind of CDMO Can a Team with Over 20 Years of Biopharmaceutical Industry Experience, Originating from the Client Side, Build?

Bioworkshops’ answer is to provide high-quality, efficient outsourcing solutions for biologics, helping global clients shorten the time required for drugs to enter clinical trials and reach the market. Furthermore, by gaining a deep understanding of the R&D process, Bioworkshops delivers one-stop, “Haidilao-style” service to its clients.Beyond its niche and refined positioning, Bioworkshops holds greater commercialization ambitions: a bulk drug substance production capacity reserve of 5 × 2,000 L and a commercial-scale sterile filling production line compliant with FDA, EMA, and NMPA standards.

Recently, VCBeat interviewed Zhu Yixiang, Vice President of Operations at Bioworkshops (Suzhou) Limited (hereinafter referred to as “Bioworkshops”).

“Many members of our team have prior experience working at sponsor companies. During our collaborations with CDMOs from the sponsor side, we encountered various challenges, such as mismatched technical capabilities, slow response times, failure to meet project-specific requirements, and delays caused by unexpected errors. Friction and issues are inevitable in such partnerships. Therefore, we asked ourselves: Could we build a CDMO that delivers more refined and meticulous services tailored specifically to sponsors, particularly small and medium-sized enterprises (SMEs)?” Zhu Yixiang mentioned. Guided by this original intention, the team systematically listed the problems they had encountered when acting as sponsors collaborating with CDMOs. These cases were discussed internally to develop solutions and achieve deliverables that better satisfy customers.

Bioworkshops, which places greater emphasis on proactive thinking and service orientation, is backed by a core team with over 20 years of extensive experience and multiple entrepreneurial ventures:Dr. Kwong Chi-Wai, CEO, is a co-founder of China Antibody and Shenzhen Longrui Biotechnology, with 30 years of experience in biopharmaceutical R&D; he has developed over 20 biologics, the fastest of which has already submitted a marketing application in China. Dr. Yang Kairui, COO, brings more than 20 years of experience in the design, construction, validation, and operation of biopharmaceutical manufacturing facilities.

Kuang Zhiwei and Yang Kairui jointly participated in the design, construction, and operational management of the world’s first GMP production facility for GE KUBio® single-use bioreactors, and co-founded Suzhou Bridge Biotherapeutics (Suzhou Qiao) in 2017. Within less than a year, Suzhou Bridge Biotherapeutics rapidly assembled a premier CDMO team, secured cumulative financing exceeding USD 72 million, and provided services to major pharmaceutical companies such as New Code Biopharmaceuticals, Kintor Pharmaceutical, Fapon Biotech, Innovent Biologics, and Junshi Biosciences. In 2021, WuXi Biologics completed a 100% equity acquisition of Suzhou Bridge Biotherapeutics.

Within less than a year, Bioworkshops established comprehensive process development and quality control analytical laboratories, as well as cGMP bulk drug substance and formulation production facilities. Unlike WuXi Biologics’ high-profile strategy, this veteran CDMO team has tapped intoA core team of professionals who grew up in domestic pharmaceutical companies has formed a flat-structured organization with deep understanding of biological drug products. The core members have been deeply involved in the biopharmaceutical industry for over ten years, leading or participating in the research and development of more than forty biological drug products. They possess comprehensive experience across the entire lifecycle of biological drugs, including specific process development, pilot-scale production, and manufacturing. Additionally, they have successful new drug application experiences in China, the United States, and Australia.

Currently, Bioworkshops owns a 28,000 m² self-owned facility, featuring cGMP bulk drug substance production capabilities with multiple scale systems (50/200/250/500 L and 5 × 2,000 L) and an aseptic filling production line with an annual capacity of 20 million units. This infrastructure enables the seamless integration of large-scale GMP manufacturing for both bulk drug substances and finished products.Proven track record in the end-to-end development and clinical sample manufacturing of monoclonal antibodies, bispecific antibodies, fusion proteins, cytokines, and antibody-drug conjugates (ADCs), with over 90 batches of GMP drug substance and finished product successfully delivered at a 100% success rate.

Bulk Solution Production Workshop (Photo provided by the interviewee)

“Delivery is not just about fulfilling the terms of the contract, but also incorporating more proactive thinking and a sense of responsibility.”Zhu Yixiang stated that to efficiently help clients bring biologics to market, it is not only essential to uphold the fundamental principle of “stability,” but also crucial for the team to respond rapidly and demonstrate proactivity.

“Since our core technical team all come from product-oriented client-side backgrounds, each of us has experienced the full lifecycle spanning sequential R&D, clinical trials, and BLA submission. A deep understanding of the product enables us to anticipate technical challenges that may arise during development. In response, our team often conducts additional preliminary research and prepares cell backups in advance, while formulating corresponding risk mitigation strategies.”

A consistent commitment to efficiency and high-quality responsibility is embedded in Bioworkshops’ one-stop CDMO service framework. “Early-stage solutions enable immediate handling of any issues arising with clients’ molecules or samples, avoiding delays caused by administrative processes such as supplementary agreements, which could otherwise slow down the overall progress. Our ultimate goal is to ensure the quality and status of process delivery, whether for regulatory reviews at various stages or for future scale-up manufacturing—this is unequivocally our responsibility.”

Since its inception, Bioworkshops has strategically positioned itself inRobust capabilities in the development and manufacturing of sterile formulations. We have established commercial-scale aseptic filling production lines compliant with FDA, EMA, and NMPA standards, offering aseptic filling services for vials (liquid injections), lyophilized products, cartridge syringes, pre-filled syringes, and injection pens. These facilities are complemented by specialized capabilities in high-concentration formulation development and lyophilization process development.

Aseptic Filling Workshop (Photo provided by the interviewee)

“We aim to provide our clients with a truly integrated, end-to-end solution that eliminates the time and costs associated with technology transfer and project management, ensuring seamless transition from early-stage preclinical sample production to commercial-scale manufacturing.”With extensive experience in fill-finish operations, Bioworkshops has been consecutively recognized as the leading CDMO for biologic drug product fill-finish in the Asia-Pacific region, having supported customers in completing over 200 batches of GMP-compliant drug product manufacturing.

As a CDMO with a global perspective, Bioworkshops has served more than 50 innovative companies in China and abroad, with 30 projects successfully filing Investigational New Drug (IND) applications in China, the United States, and Australia.“At the outset, Bioworkshops aimed to establish its foothold in China while serving global clients. Therefore, from the very beginning, all our documentation systems, source records, quality control measures, and testing methods were standardized in accordance with international requirements from China, the United States, and Europe. This robust system has laid a solid foundation for our international business operations,” said Zhu Yixiang.

Following the completion of the overall facility design and construction validation, Nick Kotlarski, COO of Bioworkshops, assumed the role of head of overseas markets. “Establishing overseas business channels is only the first step; more importantly, we must build a strong reputation through excellent service.”From rapidly establishing an international logistics chain compliant with biosafety level requirements, to implementing multi-layered security, fully encrypted data classification and backup management, and maintaining 7/24 service response capabilities, Bioworkshops has successfully expanded into overseas markets within just one year. The company has passed audits by the NMPA, EU QP, and FDA, with overseas customer orders accounting for one-third of its annual revenue during peak periods.

From a macro perspective, since the introduction ofCSPC Pharmaceutical GroupFrom the very beginning, as a key shareholder, long-termism and a conservative, steady business philosophy have become integral to Bioworkshops’ corporate DNA. “Initially, some clients were concerned that our backing by a pharmaceutical company might raise data sensitivity issues. Therefore, we invested significant effort from the outset in building a rigorous and comprehensive IT system, enabling us to confidently assure clients of data security.”

“When market saturation and sectoral downturns occur, many clients are actually quite pleased to see our background with large pharmaceutical companies. In such times, our CDMO serves as a communication bridge, providing assistance within our capabilities in areas such as resource linking and industrial collaboration, thereby unlocking greater possibilities.”