Development of manufacturing method

Aptahem collaborates with LGC Biotechnologies for the production of Apta-1, the so called Active Pharmaceutical Ingredient (API).

After performing an extensive development work, including process development of an upscaled manufacturing method, LGC Biotechnologies has produced and delivered Good Manufacturing Practice (GMP) certified Apta-1. LGC has improved the process parameters for the GMP production and with that obtained a more efficient CoG (Cost of Goods) which is an important part of creating an attractive partnering deal. The final delivery has met the company’s quality goals and also exceeded the amount of produced Apta-1 with 20% compared to the set goals because of the improved process parameter.

Formulation

The company’s collaboration partner Recipharm has developed an optimal formulation for injection/infustion (Investigational Medicinal Product, IMP) for the clinical studies.