Coronavirus Update - 09th November 2020

We would like to reassure our customers that as England enters its second national lockdown period, we remain open for business and at full capacity as we have done since the start of this pandemic and fully comply with all government guidance on minimising the risks of COVID-19.

As the situation continues to evolve, we will keep all our customers and stakeholders informed of our activities through this web-page which is updated on a regular basis.

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