In response to market demand for a more efficient and rapid scale-up of the non-GMP to GMP phases of a product’s CMC development, leading pharmaceutical manufacturer Aesica, is encouraging clients to utilise its integrated API and Formulation Development Service.
Aesica is widely recognised for its expertise in transitioning lead candidate API from medicinal chemistry into GMP development. The parallel approach between Aesica’s API Development and Formulation Development teams ensures clients will be taken into Preclinical and Clinical development more efficiently and effectively, saving time, reducing cost and simplifying outsourcing demands.
Utilising a single supplier for a product’s CMC development enables single transfer costs, familiarity of the API and allows for knowledge to be shared between the team throughout both stages of the process. During the optimisation process, Aesica provides non-GMP grade material to its Formulation Development scientists to enable early Preformulation evaluation to occur simultaneously. Once the GMP material has been synthesised, Aesica’s Formulation team manufactures the Clinical trial supply materials. Furthermore, stability testing for both Drug Substance and Drug Product is also conducted at Aesica.
Dr. Robert Hardy, CEO, Aesica said: “Clients are assigned a dedicated scientific project manager and the team works together as one to design and conduct an efficient CMC development path for our clients’ lead candidate. By unifying our expertise and capability, clients can be assured that their needs are being managed by a single outsourcing partner and in addition to a more rapid scale-up process there are also significant cost saving benefits.”
He adds: “Here at Aesica, we are committed to providing our clients with a quality and responsive service and by integrating our API and Formulation Development expertise we ensure seamless communications and effective delivery to take clients into Preclinical and Clinical development. Working with our experts, clients can simplify their outsourcing demands and benefit from a single analytical technical transfer, speeding up whole development process significantly. Our experienced team is able to provide support for API to SafeBridge ® Category 3, controlled drugs and the formulation of all dosage forms.”
Aesica is a leading full-service provider of contract research, development and manufacturing services for Formulated Products and Active Pharmaceutical Ingredients. The company develops long-term strategic partnerships with its clients, responds quickly and effectively to market demand and develops tailored solutions for specific requirements.