QCNW-Liverpool has wide experience of carrying out stability studies on pharmaceutical preparations for the NHS and commercial Pharma. The laboratory follows relevant ICH guidelines and NHS YCD’s when performing studies and can advise clients on the appropriate level of testing expected within the NHS.
The laboratory has wide experience of carrying out studies on small molecule preparations in injection, infusions, eye-drops, suspensions and creams.
Since 2008 the laboratory has developed considerable understanding, experience and expertise in stability studies on compounded mAb preparations, performing the studies for both the NHS and commercial Pharma worldwide. The laboratory is unique within the NHS Pharmacy service in its ability to deliver mAb studies.
Stability data can increase the ability and capacity of Pharmaceutical Aseptic Units to prepare and supply preparations. Freeing up clinician and nurse time, and ensuring preparations are prepared by trained dedicated staff, with improved documentation, labelling and aseptic assurance. Stability data for preparations inpatient devices can also allow them to be treated at home, which has benefits for the patient and increases hospital capacity.
The range of analytical techniques performed at QCNW-Liverpool include: pH, UV spectrophotometry, sub-visible particle counts, HPLC, dissolution, capillary gel electrophoresis (reduced and non-reduced), capillary zone electrophoresis and ELISA.