In early 2016, we at Verona Pharma were looking for a CMO to support the manufacture of clinical trial batches of our lead product RPL554 (ensifentrine), a first-in-class inhaled agent under development for the treatment of respiratory diseases with significant unmet medical needs such as chronic obstructive pulmonary disease (COPD), asthma and cystic fibrosis.
In its nebulised form, ensifentrine is sterile aqueous suspension, requiring dry heat sterilisation of API and aseptic compounding, followed by fill and finish into glass vials with flip tear up caps. We carefully benchmarked a number of CMOs with sterile manufacturing capabilities, and BioConnection stood out as having the necessary spectrum of technical capabilities and substantial relevant industry experience.
BioConnection has an impressive GMP sterile manufacturing plant with an excellent manufacturing and regulatory track record (including with EMA and US FDA). The high calibre of the BioConnection team was apparent from our earliest interactions; they rapidly assimilated our needs, and built a detailed costed and timebound project plan, embracing tech transfer, scale-up, demonstration batches and then clinical GMP batches. This initial 12 month plan was followed without deviation; all milestones were delivered on time and on budget. Many further batches were subsequently manufactured, to the expected quality and in a successful and timely manner, fuelling Verona Pharma’s successful Phase 2 clinical trials programme.
I have worked with many different CMOs over the years, and for me this has been one of the very best experiences of tech transfer, development, scale-up and manufacture of a complex product during the clinical development phase. I have no hesitation in recommending BioConnection to others.
Dr. Peter L. Spargo
Senior Vice President, Chemistry, Manufacturing & Controls
Verona Pharma plc