Aesica, the global contract development and manufacturing organisation (CDMO), provides a full high potency drug substance and drug manufacturing service, covering the production of highly potent Active Pharmaceutical Ingredients (HPAPIs) and the manufacturing of drug products with the established capabilities in place to handle drug development right through to full scale commercial product supply.
The exponential rate of growth in the market for highly potent therapeutics has caused significant challenges from API scale up through to clinical formulation and development and commercial drug product manufacturing.
Consequently, Aesica has invested heavily in its high potent handling capabilities at every stage of the process with specific high containment facilities for handling highly potent compounds available to customers. The company’s facilities offer containment for the safe handling of highly potent compounds up to SafeBridge® Category 3, whilst also providing the highest standard of cGMP manufacturing.
As a consequence of the capital and resources invested, Aesica provides full API development with scale up for clinical and commercial product requirements, formulation development, clinical trial supply, right through to full finished dose manufacturing and packaging. Included in the company’s suite of capabilities and technology are high speed blister packers and tableting machines. Furthermore, the company’s commercial scale cGMP manufacturing facilities have the capability to handle large batch sizes of high potents.
Robert Hardy, CEO at Aesica commented: “Our extensive range of potent drug services and capabilities and the high standards of quality and safety that we continue to meet mark us out as one of the world’s leading CDMOs in this specialist area. We have a strong, established track record built-up in this market over the last ten years and we look forward to continuing to meet the ever increasing demand for our services in this field as a result of the significant investment that we have put in place.”