Aptahem’s scale-up process for an efficient larger-scale manufacture of Apta-1 is finalized
Aptahem AB (Aktietorget: APTA) a biotechnology company which is developing aptamer-based drugs for the treatment of life-threatening conditions in which coagulation and inflammation work together in the disease process, announces that production process of the company´s drug candidate Apta-1 has been successfully scaled up for the manufacture of larger production volumes. The new method of manufacture which has been adapted to these larger volumes, widely exceeded the results that were anticipated by the company.
The results from the upscaling process demonstrate that the manufactured amount of Apta-1 obtained was approximately double the amount that was predicted as a result of the process. The higher efficiency of the synthesis reaction means that fewer steps are needed during the manufacturing process in order to be able to manufacture the same amount of substance with comparable quality. The new manufacturing process provides evidence that large scale volumes of Apta-1 can indeed be manufactured. The amount of residue will also be reduced as a result, which is very advantageous in the face of future commercial manufacture. By way of conclusion, the new manufacturing process has demonstrated that it is possible to manufacture Apta-1 on a large scale in a shorter time, whilst maintaining quality and with a high yield.
Aptahem has contracted BioSpring, a world-leading producer of oligonucleotides, to manufacture the Apta-1 drug candidate substance for the company’s preclinical and clinical developmental studies.
Dr. Sylvia Wojczewski, Managing Director of BioSpring comments, “Within a very short time, BioSpring has succeeded in establishing an efficient large scale manufacturing process for this novel and complex oligonucleotide-based drug candidate. We are proud to partner with Aptahem, and look forward to the delivery in the near future, of an Apta-1 product that is approved for toxicological and clinical studies“.
“This is an important milestone in the development programme of our drug candidate, since the large-scale manufacture of Apta-1 is crucial prerequisite for future partnership and commercial manufacture,” comments Mikael Lindstam, Managing Director of Aptahem. “We are very pleased with the results and with the successful collaboration with BioSpring, where the impressive value gained by the exchange has substantially surpassed our expectations. This is primarily since the overall outcome will mean lower manufacturing costs, which is an important aspect in advance of negotiations to be conducted with larger pharmaceutical companies.”
Aptahem received an additional positive notification when recently informed about the six month stability test data, where the characteristics of Apta-1 could be shown to be stable under different conditions. Aptahem is now ready to begin to manufacture Apta-1 in alignment with GMP certification (good manufacturing practice), which is a requirement for the company to later begin clinical trials in humans.
For further information:
Mikael Lindstam, CEO, Aptahem AB
Tel: + 46 (0)766-33 36 99
This communication contains forward-looking statements, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their nature, as is research and development work in the biotechnology segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios as described in this press release.
Aptahem AB (APTA) is a biotechnology company that develops aptamer-based pharmaceuticals for the treatment of life-threatening conditions in which a combination of coagulation and inflammation are involved. The company’s primary pharmaceutical candidate, Apta-1, is being developed with the aim of preventing the high mortality rate caused by organ and tissue damage in sepsis patients, among others. The company possesses patent protection in strategic target markets and actively seeks business development opportunities with potential collaborators.