CGTIC has built a synthetic biology platform to address a core challenge for the development of cell and gene therapy: designing a functional DNA or RNA sequence.Credit: Westend61 / United Kingdom / Getty
Biomedical companies, and those that provide medical equipment and healthcare, account for about 80% of the 500-plus research institutions and enterprises in Zhongguancun Life Science Park in Beijing. The park is designed to provide advanced platforms to biotech startups to tackle research and manufacturing challenges, and transform ideas into reality, efficiently, flexibly, and cost-effectively.
Engineering life in an industrial way
Cell and gene therapy has been widely recognized for its potential to develop vaccines, treat tumours and inherited diseases, and repair human tissue. The progress is extraordinary, but there are significant obstacles to overcome in research and development, as well as manufacturing.
Cell and Gene Therapy Innovation Center (CGTIC), a good manufacturing practice (GMP) facility constructed at the park and operated by LotusLake Biomedical, is finding solutions. As a contract development and manufacturing organization (CDMO), it provides a complete industrial chain covering preclinical research, pilot tests, and manufacturing of cell and gene therapies.
“There are at least 1,000 institutions globally capable of carrying out cell and gene therapy research, and more than 75% of these institutions are small companies with only a single pipeline. They don’t have the capability to build a complete industrial system for clinical transformation and manufacturing,” says Yun Jiang, LotusLake Biomedical’s executive deputy general manager.
Combining synthetic biology with technologies such as artificial intelligence, 5G and automation, CGTIC is able to accelerate development. It uses AI to design more effective DNA or RNA sequences with better affinity. It also builds high-throughput automated testing platforms for the vectors, to improve efficiency and quality. CGTIC’s strong information system helps visualize and control the entire process.
Covering an area of 15,000 square metres, CGTIC’s manufacturing capacity of DNA/mRNA, adenovirus, adeno-associated virus, lentivirus and cell therapy products can achieve 40 batches per production line.
An open platform for pilot tests
Antibody drugs are increasingly used because of their minor side effects and high efficacy, compared with traditional chemical drugs. Pilot tests are an essential step in antibody drug development, but due to major technical requirements, long construction periods, and huge costs, these platforms are often a challenge for biotech startups.
Huahui Health, a company founded by Wenhui Li at Zhongguancun Life Science Park in 2015, is now collaborating with the park to build an intelligent GMP pilot testing platform for antibody drugs. It will be equipped with digital functions, such as data collection and monitoring, to optimize production. Li was awarded the 2021 Baruch S. Blumberg Prize for outstanding contributions to advance knowledge about hepatitis B. Based on Li’s research, Huahui Health is developing a monoclonal antibody targeting the virus and has accumulated deep experience in antibody drug research and testing.
The pilot testing platform is endowed with a current GMP raw solution workshop with a capacity of 3,900 litres, a sterile water preparation workshop, and a quality control laboratory for clinical sample production and technology transformation. Upon completion in early 2022, it will be able to simultaneously provide pilot testing and production services for 10 investigational new drug (IND) application projects of new antibody drugs and 2 or 3 phase 3 clinical projects.
The platform will help biotech startups significantly reduce the cost, shorten the cycle, and improve the quality of antibody drug research and development. It also aims to accelerate the transformation of research into world-leading antibody drugs.