One 2 One supplies Active Pharmaceutical Ingredients (API) in a form that allows them to be filled and finished to produce the desired dosage form.

Custom APIs

protEcol Services can utilize its GMP capabilities to produce client-specific APIs under contract, ranging from reagent grade to those suitable for therapeutic use.

Human Growth Hormone (hGH/hST) – Human Somatropin

One 2 One has considerable expertise in the manufacture of human somatropin (hGH/hST) that allows the company to efficiently produce commercial quantities. The API product meets the European Pharmacopoeial specifications.

GMP Production and Quality System

With a fermentation capacity of 100 L and batch sizes up to 200 g, our production facility houses all the necessary equipment and services for the fermentation, midstream processing, purification and formulation of recombinant therapeutic proteins. For containment purposes areas where genetically modified organisms are present, such as fermentation, midstream process, protein refolding, wash area and liquid waste room, are all Grade D negative pressure (-15 Pa and 30 Pa). The chromatography suite, formulation, dispensing and solution preparation rooms are all Grade C (+ 30 Pa) in order to protect the product. The final filtration step occurs under a Grade A Laminar Flow Unit. An experienced QA and QC team has put in place a robust quality system enabling the company to hold a cGMP-license for production of therapeutic proteins for human use.

Manufactured in Adelaide, Australia