Current Trends in Laboratory Spray Drying Within the Pharmaceutical Industry

Sequence variants (SVs) are protein isoforms that contain one or more unintended amino acid substitutions. They can arise at a single amino acid site due to a genetic (RNA/DNA) mutation or at multiple amino acid locations, potentially due to translational errors, also referred to as misincorporations. The ability to detect SVs in protein biotherapeutics is critical due to their potential impact on structural/functional characteristics, safety, and efficacy. Trypsin peptide mapping with liquid chromatography-ultrahigh resolution tandem mass spectrometry (LC-MS/MS) provides the ideal workflow for the detection, identification, and relative quantitation of both genetic and translational SVs.

This webinar will focus on the benefits of spray-drying in addressing the solubility challenge, detailing how simple, scaleable systems can be quickly developed to provide drug products for clinical evaluation. Approaches for transitioning spray-dried dispersions to formulated solid oral dosage forms for downstream development will also be described.

Current drug development strategies are very expensive and lead to high drug attrition rates. One major reason for low success rates is the lack of predictive preclinical models for efficacy testing. The availability of induced pluripotent stem cell (hiPSC) technologies holds great promise to bring human biology to drug discovery but is still compromised by problems related to scalability, biological relevance, robustness and costs.

Innovation continues to be a primary driver of value in pharmaceutical research. However, simultaneously, research budgets are coming under ever-increasing pressure. As a consequence, pharma is moving toward a so-called open research model, one that dispenses with recurrent fixed costs in favor of a more flexible and dynamic external “spend.” By adopting this model, pharma could tap into innovation outside their walls. In this webinar, case studies will be presented highlighting the value of such collaborations, while focusing on discovery campaigns that employ highly relevant functional assays.