Process development services

Overview

Biovian offers process development services that can start from different points to suit client process and development requirements. These range from full turnkey program development to technology transfer based process adaptation to meet GMP requirements.

Biovian’s development services are based on its expertise in fermentation, cell cultivation and purification processes as part of cGMP manufacturing of biopharmaceuticals. Biovian provides linear scale-up from laboratory to full production scale aiming for high quality and cost efficiency.

Biovian’s protein purification, cell culture and fermentation equipment and facilities cover the whole range of needs and applications from laboratory bench-scale to pilot and full production scale.

Upstream development

Biovian’s upstream development services help clients establish cultivation processes for the promising new molecules. These services include:

Mammalian cell culture development
For mammalian cell cultivation Biovian can offer development of processes using different cultivation technologies and systems (adherent, suspension, disposable bioreactors). Biovian offers manufacturing in up to 100 liters working volume capacity in its disposable BioWave reactor and up to 500 L capacity in its disposable stirred tank bioreactor.

Batch, fed-batch and perfusion cultivation
The perfusion model is particularly suitable for production of unstable proteins, with low resident time in bioreactor, producing a product that can be directly harvested and purified. Perfusion also avoids accumulating toxic metabolites that might inhibit productivity of fed-batch cultures.

Biovian’s perfusion process continuously feeds fresh media to the bioreactor and constantly removing the cell-free spent medium while retaining the cells in the reactor. This produces a much higher cell density compared to continuous cultures.

Customized harvesting
Biovian can carry out upstream harvesting by depth filtration, using tangential flow filtration units for harvest clarification and further processing.

Media and feeding strategy development and optimization
Cell culture media are typically composed of more than 100 components in different concentrations. Any process improvement therefore requires detailed expertise in the nutritional requirements of the cellular production system. Augmenting process productivity demands insight into the right balance of basal and feed media. Biovian can apply detailed process design insights as wells aspects as well as tools to secure insights into intracellular networks.

Microbial fermentation development
Biovian can help the client select and develop the most appropriate program of batch or high cell density fed-batch fermentation. Biovian has in-depth knowledge and expertise in developing processes using chemically defined media and feed solutions.

Downstream process development

Once the source cultivation process or strain is identified upstream, Biovian can also offer a suite of downstream services to process the source material through isolation or purification into a finished product.

Biovian has the in-depth knowledge, highly skilled teams and wide ranging expertise to develop new purification methods for various biomolecules. Biovian can develop the rapid purification processes and scale-up to GMP manufacturing scale that create a viable platform for the manufacture of new biological molecules for therapeutic use.

Biovian’s downstream services include:

• Chromatography process development and scale-up
• Tangential flow filtration development
• Membrane processes
• Protein refolding development
• Production of proof of concept batches for drug development

Cell line Development and cGMP cell banking

Biovian offers a broad range of services that assist cell line development and expression of recombinant proteins. These include development of stable cell lines, along with cell line characterization and cGMP cell banking.

Biovian also provides also expression vector construction using a CHO-cell based expression system comprising vectors to produce recombinant proteins.

Analytical Development

Biovian provides an extensive set of analytical methods for in-process control and end product analysis. These include:

• Immunoassays (ELISA, TRF)
• HPLC (IE, SE, RP, HI)
• SDS-PAGE
• IEF
• Western blotting
• Total protein (UV, BCA, Bradford, Fluorescamine)
• Spectrofotometric analysis
• Host cell protein
• Residual DNA
• Peptide mapping
• Cell based assays
• pH, osmolality and conductivity
• Endotoxin (LAL, kinetic chromogenic)
• Sterility
• TOC
• Bioburden
• Mycoplasma
• Microbial challenge tests
• Other specific microbiological analysis

Quality & Certification

Biovian holds a GMP-license from the European Medicines Agency (EMA) covering manufacture and quality control of medicinal products. Biovian’s contract testing laboratory has been also inspected and approved by FDA and is listed on FDA’s register of approved drug companies. Biovian uses its audited quality system to govern quality control and contract analysis activities, with the focus and scope of contract development services agreed in customer-specific technical and quality agreements.

Biovian employs current and harmonized pharmacopoeial methods in contract analysis, as well as specific methods that may be transferred from customer or developed at Biovian if
required.

Biovian can also offer full validation of analytical methods to its clients.
Biovian’s 2,300 square meter cGMP facilities at Turku Science Park contain EU grade A, B, C and D class cleanrooms and a warehouse under full quality and 24/7 facility monitoring control.

Resources

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Supplier Information
Supplier: Biovian Ltd
Address: Tykistökatu 6B, Biocity FIN-20520 Turku, Finland
Tel: +358 2 27488 77
Fax: +358 2 27488 41
Website: www.biovian.com