Coronavirus Update - 07th August 2020

We would like to take this opportunity to thank our clients and staff for their continued support over this period of restricted movement. 

We remain open for business as usual and have started welcoming limited numbers of visitors to site

We fully comply with all government guidance on minimising the risks of COVID-19 and have published our risk assessment here

Our work and case studies

Challenge:

To develop stable sterile formulations of a drug substance for intravenous administration in phase I clinical trials.  The drug substance, intended for the treatment of CNS (Central Nervous System) related disorders, was physically and chemically unstable in aqueous media and there was a requirement for the product to be delivered both as a bolus and maintenance dose over an extended period of several days.

Customer:

Small biotech, USA based

Outcome:

IV formulations were successfully that remained physically and chemically stable for over 3 days.  Supporting analytical methodologies were validated to verify product stability.  The manufacturing process for sterile extemporaneous manufacture was transferred to clinic.

Phase 1 studies were initiated on a time frame that exceeded the client’s expectation by a factor of 2.  Subsequently, the client was able to complete Phase I trials ahead of initially predicted schedules and progress to Phase II.

Intravenous Formulation Phase 1 Study Challenge Case Study