deltaDOT to play key analytical role in US drive to accelerate vaccine production

UK biotech company deltaDOT is to play a key role in a new funding initiative by the US government.

deltaDOT is part of a US/UK based consortium that has been awarded a grant from the Defense Advanced Research Projects Agency (DARPA) to develop technology and processes to accelerate the production of vaccines and protein therapeutics, reducing long term storage issues and enhancing the response to a wide variety of biological threats.

The consortium, which is lead by Xcellerex, of Marlborough, MA, US, also comprises BioPharm Services (Marlborough, MA, US) and Dowpharma (San Diego CA, US).

The DARPA programme, known as the Accelerated Manufacture of Pharmaceuticals, intends to radically compress the timeline for manufacture of vaccines and monoclonal antibodies.

"The Accelerated Manufacture of Pharmaceuticals programme will twin rapid protein expression platforms with radically enhanced technologies that enable extraordinarily fast production of peptide drugs at massive quantities and at pennies per dose," said Dr Michael Callahan, programme manager for DARPA.

The US$7.9m award is for the first phase of a programme that is designed to accelerate vaccine production timescales from years down to a much shorter time. Phase I of the project will demonstrate small-scale production and analytical systems capabilities. Subsequent phases will be aimed at further process optimisation and production scale-up prior to a full-scale trial.

In the research programme deltaDOT's Peregrine HPCE and Osprey protein stability technology platforms will provide the critical and cost-effective analytical capabilities required to track product quality throughout the process from r&d to the QA/QC phase.

Peregrine HPCE protein analysis systems will be used in at-site bioreactor monitoring, product purification and final product optimisation. Osprey systems will be used in the final phases of QA/QC product testing. Xcellerex will combine its PDMax process development and FlexFactory manufacturing technologies with Dow's Pfenex Expression System, while BioPharm Services will provide advanced modeling capabilities for biopharmaceutical manufacturing facilities.

Peregrine is deltaDOT's High Performance Capillary Electrophoresis (HPCE) instrument for the 1D separation of proteins, peptides, nucleic acids, small molecules and pathogens. By incorporating deltaDOT's Label Free Intrinsic Imaging technology (LFII), Peregrine is able to monitor unlabelled proteins directly, in real time in a highly cost-effective manner. The system uses advanced signal processing and data mining tools to identify the unlabelled proteins, providing unprecedented resolution, quantification and reproducibility of analysis.

The small footprint and robustness of the system will allow its positioning at the bioreactors themselves rather than in a separate laboratory, allowing rapid and therefore relevant analysis of bioreactor conditions and protein production/purity.

The Osprey Biomolecule Stability Analyser (BSA) is a microfluidic chip-based instrument that applies aspects of deltaDOT's Label Free Intrinsic Imaging (LFII) to the characterisation of the properties of proteins, rather than to their separations, and targets the market for QA/QC of biopharmaceuticals as its first application.

"deltaDOT is delighted to be part of this prestigious and important collaboration," said Dr Tony Baxter, deltaDOT'S ceo. "This consortium project will enable us to develop our Peregrine and Osprey systems."

Dr Stuart Hassard, deltaDOT's head biologist and co-founder, added: "deltaDOT's Label Free Intrinsic Imaging (LFII) will form the cornerstone of the analytical steps in this project, from r&d through to the QA/QC stages. Our rapid and cost effective LFII technology is the perfect fit in the programme and complements the excellent technology of our partners".