Contract Services

Beta Cyclodextrin Derivatives as Protein Aggregation Modulators

Protein aggregation is the major challenge encountered during manufacturing, storage and transportation of biopharmaceuticals (1,2). The objective was to evaluate the effect of two Ăźcyclodextrins derivatives: (KLEPTOSE® HPB hydroxypropyl-Ăź-cyclodextrin, with MS=0.65) and (KLEPTOSE® HP hydroxypropyl-Ăź-cyclodextrin, with MS=0.9) on two biologic drugs (Infliximab and Etanercept) aggregation using high-throughput formulation screening (iFormulate™) and nanoDSF (Differential Scanning Fluorimetry) (3,4). Preliminary results demonstrate that KLEPTOSE® HPB BioPharma hydroxypropyl-Ăź-cyclodextrin and KLEPTOSE® HP BioPharma hydroxypropyl-Ăź-cyclodextrin at high molarity (200 mM) are efficient tools in modulating Infliximab…

Evaluating Library Databases for Microbial Identification: Critical Aspects and Recommendations

A thorough evaluation process for microbial identification systems should consist of both a technical and financial review, regardless if you are performing internal testing and outsourcing. Assessment of the library database used for microbial identifications is a critical component of evaluating a system or service in its ability to generate accurate identifications. Comprehensive depth of entries, accuracy and coverage of relevant species frequently found in aseptic and sterile manufacturing environments have a significant impact on both performance and cost. Databases…