Quality Up, Costs Down
Dr. Ackley reports that trends in the industry mirror the overall maturation of the oligo pipeline: as clinical candidates progress, GMP requirements become increasingly stringent. Dr. Ackley will speak at “TIDES” on analytical techniques the company has developed for characterizing impurities in oligo preparations. She is seeing a greater desire in the industry to understand what impurities are present in the API. Girindus is pursuing studies to characterize impurities in the raw materials used for oligo synthesis and correlating those to impurities detected in the final product.
Citing a common theme evident at the recent “BioEurope” conference, Rethage agrees that clients are seeking help in modeling the future commercial volume supply chain and cost of goods. Clients with early and mid-stage projects that are looking for funding or licensing partners want evidence—“credible numbers based on real experience”—that they will be able to bring down the cost of goods for APIs in the future.
“We are confident that our price/volume models for the future using new supply chains will be sustainable,” says Rethage. Avecia’s projections draw on its past experience producing its own amidites and leveraging its experience manufacturing a substantial project portfolio. The company has demonstrated, based on process validation experience and the use of statistical modeling in process development, that it can accelerate process validation and reduce the cost by as much as 80%, according to Rethage.
Avecia is investing in additional approaches to reduce costs associated with synthesis, primarily focusing on the installation of an Oracle enterprise resource planning system to increase standardization and automation of internal processes to achieve greater stability and predictability. Other ongoing investments include the implementation of the Pilgrim quality management system to improve and increase the reliability of regulatory compliance, of Corrective and Preventive Actions, audit, and training processes and reduced costs.
Biospring, a German CMO, also reports increased demand from the pharma sector for both DNA and RNA therapeutics, with an emphasis on intermediate- and large-scale quantities. The company is expanding its GMP production capacity by building a second facility at its existing corporate site, according to Hüseyin Aygün, Ph.D., CSO.
Commenting on overall trends in the oligo market sector, Dr. Aygün describes interest from European customers in projects focused on novel therapeutic applications for oligos. He also reports strong demand for better product characterization. In response, Biospring has initiated a program for sequencing highly modified oligos using MALDI mass spectrometry techniques, which are based on chemical rather than enzymatic fragmentation. MALDI-MS analysis is particularly useful for RNA, including sequencing of duplex RNA.