The pharmaceutical finance circle was informed that in Suzhou, in March 2024, the production capacity of the aseptic production line of Kangri Baiao will be doubled, and the cumulative filling capacity of the commercial aseptic filling line (pre-filled needle, cartridge, water injection, freeze-dried) will reach20 million per yearAt the same time, the overall filling production speed has been doubled, and Bioworkshops will deliver aseptic filling products to customers with higher quality and faster speed.
In order to meet the diverse needs of customers for different processes and dosage forms, Bioworkshops will expand the production capacity of sterile vials (lyophilized water injections), commercial sterile prefilled needles, injection pens, and cartridge filling lines in 2023. After the expansion of production capacity, it can flexibly meet the aseptic filling services of different types of biologics from preclinical to commercialization.
The aseptic filling line has passed the EU quality authorized and FDA third-party audit, and up to now, Bioworkshops has successfully become a global biomedical partnerDelivered more than 200 batches of GMP aseptic filling services with a 100% successful delivery rate. The scope of services includes monoclonal antibodies, bispecific antibodies, vaccines, fusion proteins and other biologics.
With the significant increase in production capacity, Bioworkshops will have a stronger ability to support partners at different stages of projects and customized needs. Whether it's low-volume production for early-stage clinical trials or large-scale sample delivery for commercialization, we can respond quickly and provide high-quality one-stop service. Especially in terms of commercial pre-filled needles, injection pens and cartridges, Bioworkshops has adopted the industry-leading aseptic robot arm to automate the intelligent filling process to ensure high precision and reliability.
After the overall expansion of the aseptic filling line, the filling efficiency will be further improved, helping customers speed up the process of product launch and reduce the risk of technology transfer.
Bioworkshops will continue to strive to become a leading macromolecule CDMO company and help global biomedical innovation projects rapidly advance the clinical and commercialization process. Provide partners with a more complete and comprehensive one-stop solution for CDMO.
About Bioworkshops:
BioworkshopsIt is a professional biopharmaceutical CDMO, located at No. 5 Dongwang Road, Suzhou Industrial Park. The company's services include biopharmaceutical process development, cGMP drug substance production, aseptic preparation filling, etc. The team members are experienced biopharmaceutical industry veterans with a deep understanding of the biopharmaceutical CMC field. Bioworkshops has a production capacity of 13,000 liters, and has aseptic preparation filling services including vial water injection, lyophilization, cartridge bottles, prefilled needles, injection pens, etc., which can fully realize the efficient connection from early preclinical sample production to commercial production.
BioworkshopsIt has successfully helped multiple partners' monoclonal antibodies, bispecific antibodies, polyclonal antibodies, ADCs, fusion proteins, cytokines and other projects to obtain clinical approvals in China, the United States, Australia, etc.
BioworkshopsWe are committed to providing global partners with efficient and high-quality biopharmaceutical outsourcing service solutions to help them shorten the time for drugs to enter clinical trials and go to market.
The company's business scope:
Cell line construction |Cell culture |Purification Process Development |Formulation Formulation Development |Analytical Method Development |Process CharacterizationProcess Validation |cGMP production of drug substance and finished product (200L, 500L, 2000L) |Aseptic filling (prefilled needles, cartridges, pens, vial water injections, lyophilization).