GMP peptide manufacturing
Generic Active Pharmaceutical Ingredients (APIs) Product Line
Our generic API product line focuses on women’s health, diabetes and osteoporosis.
|Peptide name||Mode of action and clinical use|
|Atosiban||an inhibitor of the hormones oxytocin and vasopressin used as an intravenous medication as a labour repressant to halt preterm labor (Gynecology, Obstretrics).|
|Cetrorelix||an injectable gonadotropin-releasing hormone (GnRH) antagonist used in assisted reproduction (Gynecology).|
|Bivalirudin||a thrombin inhibitor. It inhibits both circulating and clot-bound thrombin, while also inhibiting thrombin-mediated platelet activation and aggregation (Cardiovascular).|
|Liraglutide||used to treat diabetes mellitus type 2 and obesity (Endocrinology).|
|Semaglutide||used for the treatment of diabetes mellitus type 2 (Endocrinology).|
|Teriparatide||a form of parathyroid hormone consisting in the bioactive portion of the hormone. It is an effective anabolic (promoting bone formation) agent used in the treatment of osteoporosis (Endocrinology, Musculoskeletal).|
|Elcatonin||a caltonin derivative used as an anti-parathyroid agent for remitting or eliminating pain caused by osteoporosis (Endocrinology, Musculoskeletal).|
New Chemical Entities (NCE)
For the most stringent requirements, we have delivered peptides with > 99.5% purity and less than 0.1% of any single impurity.
The typical components are:
- Process development, optimization and validation
- Process control and impurity studies
- Comprehensive analytical studies
- Three batches for process validation
- Stability studies and documentation preparation
- Drug Master Files (DMF) and market registration / Regulatory affairs
Figures: Space Peptides is expanding with a large-scale manufacturing site in Jiangsu, China, with a total capacity of 1100kg/year (in progress).