Excelsyn chases process improvement
advance" in a protein intensification process that can be used to
slash the manufacturing costs of a range of amino acids.
The English firm said it has made its initial progress with the unnatural amino acid tert-L-leucine (tert-butyl glycine - TBG) - a compound used in the synthesis of several major new drug candidates.
Excelsyn has achieved this through the improvement of its transaminase technology as part of a three-year program that began in 2004 to target more efficient, lower-cost routes to TBG using biocatalyst technology.
"The first application to TBG manufacture has reduced the cost of manufacture by 25 per cent and a second generation catalyst still under development is set to improve this still further," Excelsyn chairman and CEO Ian Shott told a press conference at the recent CPhI show in Paris.
"We expect strong multimillion dollar sales to follow from this."
Transaminase technology is a three-enzyme, whole-cell platform that converts keto acids into amino acids. TBG is the most advanced commercial application of this technology that can be extended to other, unnatural amino acids.
Other, chemical routes to unnatural amino acids are often based on asymmetric hydrogenation but this can become very costly at commercial scale.
On the other hand, Excelsyn claims its approach using biocatalysis overcomes this limitation and is highly scaleable.
"We have been able to use our technology to eliminate at least one fermentation step from the multifermentation production process," said Shott.
"As drugs become more complex and costly to produce, finding better routes to TBG and other key amino acids will have significant cost-of-goods implications for several key drug candidates in current development."
Excelsyn said it has now appointed fermentation partners to scale-up the newly enhanced TBG process.
Meanwhile the firm also announced that its Pharmaceutical Services group has become the latest player in the sector to join big industry names such as AstraZeneca, GSK, ICI and Johnson Matthey in the Britest process improvement organisation, focused on bringing a more innovative approach to manufacturing process design in pharma chemical manufacturing.
Britest methodologies work through a "toolkit" to analyse processes and determine potential improvements to yield, quality, throughput, and reliability that can be achieved through improvement of conventional batch manufacturing operations, or the application of process intensification techniques.
Excelsyn said its Molecular Development division has already achieved significant productivity savings from working with Britest.
