PaizaBio has gained approval from China’s FDA (CFDA) to add new aseptic injectable production capability at it production facility in Hangzhou, China. This expansion will increase the company’s annual fill/finish capacity from 300 million units to 400 million, including vials, pre-filled syringes and cartridges.
 
The capacity will focus on small molecule drugs for clinical trials and small batch production and the company anticipates reaching full-scale production by 1Q17.
 
PaizaBio founder and chief executive officer Stuart Rose said, “We are very pleased the CFDA has given its approval. Not only does it reflect the CFDA’s confidence in our quality standards in the very challenging aseptic fill-and-finish arena, it also reflects China’s focus on becoming a leader in the global pharmaceutical industry, which includes biologics and biosimilars.”
 
PaizaBio also plans to expand its newly operational clinical trial capability in biologics to full commercial-scale aseptic manufacturing in the near future.
 
Mr. Rose said the decision to expand PaizaBio’s capabilities and capacity is also the result of recent CFDA policy changes that provide a fast-track approval process for new, innovative drugs and allow drug innovators to use CMOs to commercialize new drugs in China, for the Chinese market, whether the innovators are Chinese or multi-national pharmaceutical companies.
 
“China is signaling that it is open for business in the pharmaceutical sector to those companies that understand and ‘play’ by the new rules,” Mr. Rose said. “We are very pleased to secure the CFDA’s approval and to be at the forefront of this new era in China.”
 
PaziaBio’s current contract manufacturing capabilities in China include aseptic fill-and-finish for biologic and small molecules clinical trial and commercial scale, lyophilization, packaging, warehousing and logistics, and a newly formed consultancy.