Advanced analytical capability
Vectura’s advanced in-house analytical capability further cements the Company’s ability to support all phases of inhalation product development. Vectura has extensive state-of-the-art analytical testing facilities and equipment, and an expert analytical workforce able to fully develop and validate all of the methods required to characterise complex inhalation products not just for small molecules and combinations thereof but also for complex biologic inhalation products. The pharmaceutical development of inhalation products requires many decisions to be made along the way. Most decisions are based on the analytical data generated, making Vectura’s advanced analytical capability a key strength of the organisation.
Scale-up and industrialisation expertise
Vectura has the expertise to develop product manufacturing processes, ranging in scale from small laboratory, all the way through to commercially relevant scale, offering a seamless transition and transfer out to commercial product manufacturing sites.
The Group has a proven ability to advance products from early development stages all the way through to commercial production. Vectura also has strong clinical and regulatory capabilities to complement its technical formulation, device, analytical and manufacturing expertise.
GMP1 Facilities - Laboratories and Manufacturing suites
We have the expertise to develop manufacturing processes ranging in scale from laboratory testing all the way through to commercially relevant scale-up, including the manufacture of clinical supplies for large scale clinical studies. This enables us to offer a seamless transfer out to commercial manufacturing sites.
1 "GMP" — Good Manufacturing Practice.
Comprehensive regulatory and clinical expert capabilities
Vectura has a strong team of experienced professionals in all development-related disciplines required for taking drugs and drug-device combinations from pre-clinical development right through to regulatory submission (MAA – Marketing Authorisation Application or NDA – New Drug Application) and post-approval. The Clinical/Regulatory Development team is composed of more than 40 scientists with experienced background and positive track record in the respiratory field emanating from different biotech, medtech, pharma-industries and also academia.
Outside of the big pharma organisations active in the field of inhalation product development it is really only Vectura that is able to bring together all of the disciplines required to seamlessly work together to create a successful product. It is Vectura’s ability to successfully combine all of the required technologies and capabilities that makes the Company a global leader in the field of inhalation product development.
experienced scientists in our clinical and regulatory teams.