MVIC has Manufactured a GMP Batch Used in a Clinical Study – Positive Results
MVIC has for a customer successfully QA-released a GMP batch of a respiratory combination product. The MVIC activity included mixing of API and excipients as well as assembly and filling of device components. The product is a reservoir dry powder inhaler (DPI) where the dose is metered by the subject/patient. The MVIC undertaking also includes one initial technical batch and both batches have been assessed in stability testing. The batch has now been successfully used in a clinical equivalence BE study with positive results.