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Biopharm unveils BioSolve Process 5

Software demonstrates how shift from stainless steel to continuous processing technology potentially reduces CAPEX by over 75% and CoG below $20g/L

Biopharm, the bioprocess analysis software developer, today announced the introduction of BioSolve Process 5, the latest version of the company’s flagship software tool. The company also published BioSolve Process data that clearly illustrates the benefits of modular single-use and continuous processing technologies in reducing capital expenditure and cost of goods in the development of monoclonal antibodies.

BioSolve Process is the biopharmaceutical industry’s leading process analysis and economic modelling package, providing insight that enables biopharma innovators to reduce manufacturing costs and make informed process decisions to improve profitability and ultimately patient access.

Unlike in-house modelling 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.

In addition to two new unit operations – viral inactivation and UF/DF – BioSolve Process 5 comes with some unique new features, including:

  • 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 optimise this often ignored but important area of bioprocessing that typically absorbs a lot of cost.

BioSolve Process 5 is also fully integrated with a central database for model, data and process management. The seamless integration with Biopharm’s enterprise application, BioSolve Connect, allows users to future proof their investment by sharing processes, facility information, cost data sets, unit operation models centrally.

“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.”

“For our case to assess the impact of innovative technology, BioSolve was the right tool,” said Jim Velez, Merck & Co. “We were able to generate multiple scenarios and sensitivity rapidly.”

Mab manufacturing today and tomorrow

In conjunction with the release of BioSolve Process 5, Biopharm has released a whitepaper demonstrating the significant savings that can be achieved by biopharma innovators in monoclonal antibody manufacture. The study used BioSolve Process to evaluate three different development scenarios:

Current stainless steel technology
Modelling in BioSolve Process 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.

Modular single-use technology
BioSolve Process 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.

Continuous processing technology
BioSolve Process was used to model a fully integrated continuous manufacturing operation. Moving to continuous manufacturing was shown to have the potential to drop the capital requirement to just $80 million and the CoG to $32/g, with the potential for further reductions to the $15/g to $20/g range.

“What we can see from this study is that technology choices have a significant potential impact on capital expenditure and cost of goods. De-risking biomanufacturing during development is in everyone’s best interest,” said Sinclair. “Access to this knowledge through BioSolve Process can make it easier for the industry to widen patient access and implement local manufacturing.”

About Biopharm

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, the biopharmaceutical industry’s most powerful set of bioprocess analysis tools. The BioSolve product range enables biopharma innovators to reduce manufacturing costs and make informed process decisions to improve profitability and ultimately patient access.