The move enables the scientific consultancy to now test according to the procedures set out in USP <787> Subvisible Particulate Matter in Therapeutic Protein Injections; a recently modified chapter which specifically addresses the unique sensitivities of protein formulations and high cost of sampling for compliance purposes.
“This new test method is a positive addition to our analytical capabilities; enabling us to offer pharmaceutical and biopharmaceutical manufacturers a cost-effective alternative to USP <788> for therapeutic protein injectable and related liquid preparations. We are now able to handle much smaller sample volume and test aliquots - as per the latest pharmacopeia regulation – to achieve significant cost savings for our clients, but without compromising any aspect of data validity, formulation quality or product safety,” explains Yohanes Tamene, Scientist at RSSL.
Under the requirements of USP <788>, a combined volume of 25mL of pooled sample volume is required per single test to determine particulate counts. This compares to a total sample volume of just 1mL set out in the more recent USP <787> which translates to a reduction of 96%. Given that quality testing must be carried out on every product batch, this saving represents a strong cost benefit for manufacturers of expensive protein-based therapeutic products.
“We know that when it comes to injectable and parenteral products, the presence of SVP can seriously compromise their safety, quality and efficacy. It’s a challenging environment where any changes to product formulation, manufacturing process or exposure to stress conditions can prompt demands for additional sampling analysis. In addition, health authorities are also increasingly demanding SVP data which goes beyond that which is specified in the pharmacopeia. With this in mind, we felt it was vital to increase our capacity and offer customers the option of this additional service which is designed to balance compliance with commercial concerns,” states Yohanes.
RSSL offers routine SVP testing to support batch release, as well as bespoke analysis to help during product development, reformulation and problem solving. Using complimentary techniques, its expert team can carry out tests to determine the level of SVPs and identify the root cause of high counts.
Learn more about our Subvisible Particle Analysis Services.
For further information or to discuss your requirements, please contact the RSSL customer services team on +44 (0)118 918 4076 or email enquiries@rssl.com.