Read our expansion updates

Verona Pharma

‘One of the very best experiences of tech transfer, development, scale-up and manufacture’

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

bioconnection

Covid-19 update BioConnection

BioConnection has taken precautions related to the global outbreak of the Covid-19 virus. To start with; we are currently in full operation and running on-schedule with regard to our planned productions. Our production department is on full strength and we have no shortages of material(s) nor do we foresee them.

For our personnel we are following the guidelines as issued by the Dutch National Institute for Public Health and the Environment, RIVM (www.rivm.nl). This means that people stay at home when they show (early) symptoms connected to Covid-19. Furthermore BioConnection employees work from home as much as possible. We avoid shaking hands and keep distance from each other. We take every precaution as advised to prevent the spread of the Covid-19 virus and will fully comply to the requests as stated and/or enforced by the authorities.

Our expansion project (expansion.bioconnection.eu) is running as planned to start GMP production in Q2 2021. We stay in close contact with our suppliers for the production equipment.

We review for Covid policy changes by the authorities on a daily base and adapt to them. If changes occur, this statement will be updated accordingly so you always have the latest information. In case you have any questions, please do not hesitate to contact us via our general number or website. Current customers of BioConnection, can contact their dedicated program manager. In case you want BioConnection to become a partner in your development or manufacturing, please contact our Business Development department via contact@bioconnection.eu.

The BioConnection Management Team.

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