Bioworkshops: Breaking Out of the Traditional Drug Development Mold
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Bioworkshops: Breaking Out of the Traditional Drug Development Mold

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Dr Nick Kotlarski, COO, BioworkshopsDr Nick Kotlarski, COO
Today, China is the second-largest market for pharmaceutical products. Particularly since the implementation of the ‘National Key New Drug Creation Programme’ (2008), China’s biopharmaceutical sector has been achieving rapid development in domestic drug research and development (R&D). At the same time, the regulatory reform of Marketing Authorization Holder (MAH) systems suggests that China’s role in pharmaceutical research will change considerably over the next 5-10 years. Even many international drug R&D companies are already turning to Chinese CDMOs to collaborate and develop new drugs. And this paradigm shift is now creating a sharp increase in demand for CDMOs proficient in manufacturing of new biologic products.

Against this backdrop, the Chinese biopharma sector also needs to ensure that they break the mold of their long-standing operating model and imbibing international quality and operational standards. Only then can Chinese biopharma companies drive faster innovation in drug development and compete at par with other countries. Enter Bioworkshops. Based out of China’s Suzhou industrial park, Bioworkshops provides development and manufacturing services for customers producing biologics, delivering quality and compliance to global standards. “Bioworkshops benchmarks against international standards to include trends in technology and regulations; that’s what makes us stronger,” enthuses Dr Nick Kotlarski, the COO of Bioworkshops.

Notably, it is Bioworkshops’ team of experienced industry leaders with a deep understanding of the technical chemistry, manufacturing, and controls (CMC) requirements of this field that helps the company have an open-minded approach to drug development. The company’s in-house subject matter experts (SME) cover every step from biologics development to commercial product registration. Bioworkshops can thus provide the full range of development and cGMP manufacturing functions from cell line, drug formulation, analytics, and process optimization to finished sterile product. This expertise further helps Bioworkshops to provide outsourcing services in undertaking risk-based development of monoclonal and bispecific antibodies (BsAbs), fusion proteins, and other recombinant proteins from mammalian cell culture. Dr Kotlarski highlights, “Our staff share the unified mission of applying their expertise in achieving rapid approval of clinical and commercial biopharmaceuticals.” He further adds, “We maintain key documentation in Chinese and English to streamline inspection by foreign inspectors and facilitate dual registration of our clients’ products.” Therefore, Bioworkshops’ clients can develop their products in China in parallel with other major markets, such as Europe or the U.S.

Bioworkshops benchmarks against international standards to include trends in technology and regulations; that’s what makes us stronger

What takes these strong development capabilities a few notches higher are Bioworkshops’ FDA, EMA, and NMPA compliant cGMP manufacturing facilities. The size and capacity of these facilities give clients the necessary confidence for partnering with Bioworkshops for the full product lifecycle. Bioworkshops’ manufacturing facilities have multiple lines for drug substance built to handle 6 x 2000L capacity and filling line with open restricted access barrier system (oRABS) for aseptic filling of liquid into vial sizes from R2 to R50. Single-use process equipment is used extensively, even in the filling line. This gives the company great agility in scheduling manufacturing campaigns, assuring product quality, and meeting customers’ timelines.

Looking at these innovative and cutting-edge approaches to drug development, it is no wonder that Bioworkshops has crafted a niche of its own in the booming Chinese CDMO sector in a very short time. The company started to deliver services to clients within three months of its official launch in 2019. For the first client, Bioworkshops delivered development work from gene sequence to 500L scale production of drug substance for a biosimilar candidate in 11 months. Along the way, Bioworkshops sourced and characterized innovator product to set the Quality Target Product Profile (QTPP) for developing and locking the manufacturing process. This was achieved at the same time that Bioworkshops built and validated its facilities for development and manufacturing. In another instance, a client faced a roadblock in their drug development program due to unexpected high mannose (Man-5) glycoformin their desired antibody, which rendered the product toxic and unsuitable to use. Using their scale-down cell culture and purification models, Bioworkshops took only two months to redevelop an optimized process to bring the concentration of Man-5 under control.

It is also important to note that Bioworkshops achieved all these feats while dealing with the COVID-19 pandemic. Even though the company’s operations were suspended at the start of the outbreak, Bioworkshops was swift to implement the control measures recommended by the national and local governments. This helped the company be one of Suzhou’s first companies to obtain approval and resume full operations on 10 February. Summarizing his company’s journey in the last year, Dr. Kotlarski says, “Our team has achieved a lot in our first 366 days. We have created a great foundation for many years of future success.” And already building on that foundation, Bioworkshops has forged a strategic partnership with Quacell Biotechnology for providing CHO-K1q system-based cell line development services. According to the COO, this collaboration is an example of the kind of alliances Bioworkshops is poised to build for incorporating more robust drug manufacturing capabilities. “We will continue to promote innovative process technology and applications, such as high-yielding expression systems, continuous/hybrid processing, and formulation science, to make many new biologic medicines and help patients around the world,” concludes Dr Kotlarski.

The vision, scale, rapid start-up, and immediate positive impact of Bioworkshops is outstanding. They are a leading biopharma service provider.
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Company
Bioworkshops

Headquarters
Suzhou Industrial Park, China

Management
Dr Nick Kotlarski, COO and Dr Simon Kwong, CEO

Description
Based out of China’s Suzhou industrial park, Bioworkshops provides development and manufacturing services for customers producing biologics while delivering quality and compliance that meet global standards. The company’s in-house subject matter experts (SME) cover every step from biologics development to commercial product registration. Bioworkshops provides the full range of development and cGMP manufacturing from cell line, drug formulation, analytics, and process optimization to finished sterile product. Bioworkshops applies this expertise to risk-based development of monoclonal (mAb) and bispecific antibodies (BsAbs), fusion proteins, and other recombinant proteins to serve its clients

Bioworkshops