In 2020, Bioworkshops continued to breakthrough and develop at a high speed. As a new CDMO, “Bioworkshops speed” has become recognized within the industry and acclaimed by our customers. In the past year, Bioworkshops exceeded its targets and achieved great results.
In 2020, The rapid development of our busines is based on solid foundation and a strong team.
In May 2020, we completed the construction and validation
of all facilities including 4,800m² of cGMP Drug Substance and Fill&F
finish workshops. This marked the end of our initial building
phase and move into full operation for the 28000m² self-owned
factory in Suzhou. It only took 88 days to complete the construction of the GMP
drug substance workshop, built to take a maximum capacity of 6×2,000L, and
quickly started the first batch of pilot scale GMP production. In July 2020, we
delivered the first batch of 500L GMP production. Our expert team took only 4
months from the completion of the plant to deliver 3 batches of GMP drug
substance and drug product for the first project. Later in the year we set an
even faster record, completing a campaign of GMP drug substance and drug product
batches only 94 days after receiving the top 6 clones from our client.
In 2020, we streamlined processes for technology transfer and reinforced our CMC development technology service platform. Process development, transfer to production, and GMP pilot manufacturing were completed for 3 projects, with a success-rate of 100%.
Bioworkshops is the youngest biologics CDMO in Suzhou, but the deep biopharmaceutical product development experience of our staff up to 2,000L scale is without parallel. We are committed to deliver novel medicines at “Bioworkshops speed” for more customers across all scales of production up to 2,000L.
Recognition of quality
In November 2020, we undertook and successfully passed an EU QP audit for manufacture of Drug Substance and Drug Product, confirming that we provide customers with the production and analytical services that meet EU GMP standards for investigational medicinal products. The facilities, equipment, and quality system of Bioworkshops were proven to be of international standard.
In November, we also passed an on-site inspection by the Jiangsu Provincial Drug Administration and obtained a Drug Manufacturing License.
During the year, Bioworkshops also successfully passed on-site inspections by numerous clients .
Growth and breakthrough
Bioworkshops won two industry awards during 2020, both recognizing the company’s rapid development and delivery cutting-edge services to biopharmaceutical enterprises: "Future Star of China Biomedical CDMO Enterprises in 2020" issued by Shining Star List and "Top Pharma Outsourcing Consulting/Service Companies in APAC" issued by Pharma Tech Outlook, a top Asian pharmaceutical industry magazine.
The rich experience of our employees is the core asset for the company. As the company grows and the team expands, every “Bioworkers” shares their insights and experiences about the industry with each other. With the passing milestones of delivery for each project, the strength of the team is becoming more evident and outstanding. Thanks for everyone's contribution to our company.
Bioworkshops thanks our customers for their recognition and support in 2020. “Customer first” is our founding philosophy, and we also commit to continuously improve our project services. We also thank the Suzhou government for acknowleding Bioworkshops’ "Innovation Strength" and "Practice Speed”, and we are looking forward to enabling more Biopharmaceutical Enterprises to accelerate development of their biologic products.
In the course of 2020, we actively engaged with our customers, broadly across the industry, and shared our experience through a variety of professional industry platforms, making more people aware of Bioworkshops. The explosive growth of the past year is only the beginning for Bioworkshops. We will continue to grow and create our future of unlimited possibilities.