One of MVIC´s expertise areas is dry powder formulation development. We have the ability to mix formulations from a few grams up to kilogram scale. MVIC experts have extensive knowledge and experience in designing formulations to meet target requirements.
All relevant parameters come typically in play including particle size, carrier quality, use of lactose fines and ternary agents, mixing parameters etc. We do the formulation development as series of designed experiments, DOEs.
MVIC has fit-for-purpose analytical capacity including delivered and fine particle dose assessment as well as expertise in solid state. MVIC works fast, dedicated and target oriented, without unnecessary bureaucracy.
Manufacturing to GMP standards
MVIC has recently manufactured and filled generic dry powder formulation batches which are currently being tested in a clinical study. MVIC has done all specification and stability testing at GMP level (except microbiology) included in the regulatory CTA submission.