Full Name: BioSolve Process 5
Debut: May 2014
Field Position: Executive operations management
Skill Set: BioSolve Process 5 process analysis and economic modeling platform provides insight that enables biopharma innovators to reduce manufacturing costs and make informed process decisions to improve profitability and ultimately patient access. Unlike in-house modeling systems, BioSolve Process accesses the latest technologies and processes from across the biopharmaceutical sector to deliver impartial knowledge, allowing users to quickly carry out multiple process comparison analyses before making a commitment.
• Improved continuous and hybrid process modelling, allowing users to determine how much and where continuous processing could provide a benefit in their processes.
• Enhanced facility fit options, allowing users to rapidly screen their facilities for the best place to manufacture their product.
• Improved solution make up from stocks and in-line buffer dilution, providing more options to allow users to optimize this often ignored but important area of bioprocessing that typically absorbs a lot of cost.
Regulatory Profile: Supports compliant cGMP and QbD-based capacity planning and capital investment.
Coach’s Notes: “With the new developments in BioSolve Process 5, there is a strong focus on continuous process modelling, which reflects many of our customers’ ambitions over the past year,” said Andrew Sinclair, CEO, Biopharm. “We have seen BioSolve Process used in a range of scenarios, from building a business case for a fully integrated continuous biomanufacturing platform to the development of an integrated continuous purification process template for monoclonal antibodies.”
Scout’s Notes: A Biopharm whitepaper reveals significant savings can be achieved by monoclonal antibody manufacturers. The study evaluated three different development scenarios. With current stainless steel technology, BioSolve process modelling shows that for a traditional stainless steel facility, an optimum CoG of $35/g can be achieved with a capital investment of $352 million into the manufacturing plant. For modular single-use technology the software shows that a modular single-use facility can deliver a comparable CoG at $38/g for a much lower capital investment of $250 million, by shifting cost from fixed to variable costs. With continuous processing technology the model revealed that moving to continuous manufacturing identified the potential to drop capital requirements to just $80 million and the CoG to $32/g, with the potential for further reductions to the $15/g to $20/g range.
Team Resources: Biopharm was founded in December 1998 to develop technology solutions and services for the biopharmaceutical manufacturing business, covering biologic products, facilities and manufacturing strategy. The company is the developer of BioSolve bioprocess analysis tools which enables biopharma innovators to reduce manufacturing costs and make informed process decisions to improve profitability and ultimately patient access.