Biovian is pleased to present its two newest investments in capacity: New 200 l Wave bioreactor for mammalian cell culture and new 300 l stirred tank Bioreactor for microbial fermentation.

The Wave Bioreactors are used in mammalian cell culture, typically producing antibodies or other recombinant proteins for clinical trials. The advantages with the disposable Wave-bag technology are fast campaign changes, low cleaning and maintenance costs and high production yields. By using high-producing cell lines combined with fed-batch or perfusion technologies, the material demands for clinical trials can be fulfilled even under stringent timelines. Biovian has worked with disposable bag Wave bioreactors over a number of years and gained the necessary expertise and experience required to use this technology effectively. That has further helped Biovian to provide its customers cost effective services in the production of clinical trial material within demanding time frame.    

The new 300 l stirred tank bioreactor will bring versatility to Biovian's microbial fermentation production capacity: Combined with the earlier, existing fermentation capacity, a faster throughput of clinical batches and possibility to handle multiple microbial projects simultaneously are some of the main advantages brought in by the new 300 l stirred tank Bioreactor.    

"We are very pleased to see this new capacity and technology to be made available to our customers" says Dr. Pirkko Kortteinen, Director of Manufacturing and Development at Biovian Ltd. and continues: "We are using state-of-the-art technology combined with the expertise of our highly skilled staff. As an example, Biovian is in the front line in taking the Wave technology in use." This increase in production capacity improves the ability of Biovian to serve its customers.    

In parallel with the increase of mammalian cell cultivation and microbial  fermentation capacity Biovian has expanded its contract manufacturing license to also include contract quality control analyses.  Biovian's contract analysis licence authorises Biovian to perform drug substance and drug product analyses for QP (qualified person) release purposes. The service offered includes protein analyses, cell based assays, sterility test, endotoxin test and other microbial impurity assays.    

These quality control analyses are performed according to Ph.Eur. and USP as required.    

"This service is an important addition to our portfolio of services as a CMO," says Dr. Knut Ringbom, from Biovian and continues: "It brings added value to our customers by offering them the one-stop-shop concept."  

ABOUT BIOVIAN  

Biovian is a one-stop-shop that specializes in process development, scale-up and cGMP contract manufacturing of biopharmaceuticals. Biovian provides full range service from antigen isolation, expression condtruct and cell line development, process development, cell cultivation, protein purification to product fill and finish. Biovian’s cGMP facilities and state-of-the-art equipment enable flexible pilot production and development services.  

BIOVIAN’S cGMP CONTRACT MANUFACTURING SERVICES         

• Fermentation & cell culture Viral vector production
• Protein purification
• Formulation
• Aseptic fill and finish
• Lyophilisation
• Analytical Quality Control Services (Ph. Eur. and USP)
• Stability studies according to ICH guidelines
• Cell banking and storage  

BIOVIAN’S COMPLEMENTARY SERVICES    

• Cell line development Process development
• Analytical development
• Proteins for research purposes
• Diagnostic reagents (e.g. antigens or mAb’s)  

QUALITY CONTROL SERVICES    

Quality control services for drug substances and drug product release The service offered includes protein analyses, cell based assays, sterility test, endotoxin test and other microbial impurity assays. Quality control analyses are performed according to Ph.Eur. and USP as required.  

BIOVIAN FACILITIES

Biovian is located in Finland, in the heart of TurkuSciencePark with excellent connections through both Turku and Helsinki international airports. Biovian’s inspected 1600 m2 cGMP facilities contain EU grade A, B, C and D class clean rooms and warehouse under full quality control as well as extensively equipped development laboratories. Biovian holds manufacturing authorization from NAM (Finnish National Agency for Medicines) and complies fully with the EU GMP. Biovian has biosafety level 1 and 2 laboratories and is capable to handle micro-organisms classified to GMM1 and GMM2. Biovian has been inspected by the Finnish Board for Gene Technology.  

CONTACT INFORMATION  

Knut Ringbom    
Director, Projects and Marketing    
Direct +358 2 274 8877    
Mobile +358 40 517 1217    
e-mail: knut.ringbom@biovian.com  

Sakari Heyno, CEO    
Direct +358 2 274 8847    
Mobile +358 40 509 3210    
e-mail: knut.ringbom@biovian.com    
General Inquiries    
e-mail: contact@biovian.com