Key Quality Attributes of Parenteral Grade Excipients
Quantitative Characterization of Sucrose, Trehalose, and Mannitol The complexity of large molecule and cell-based therapeutics continues to increase. This trend, coupled with an evolving regulatory landscape across the globe, has driven requirements for enhanced characterization of critical formulation components, especially for injectables. As a US-based cGMP manufacturer of critical stabilization technologies such as trehalose, sucrose, maltose, and mannitol, Pfanstiehl has performed quantitative characterization for several key quality attributes, down to levels well beyond those required by the pharmacopeia. The intent is to share quantitative (rather than qualitative) data with formulators, not only for peace of mind in terms of long term regulatory compliance, but to remove unknowns from experimental design and enable scientists to build more robust formulation platforms. Quantitative data for multi-compendial release testing, total and elemental impurities (down to low ppb levels), endotoxins, glucans, and sub-visible particles are disclosed herein.
Profiling Metal Content in Parenteral Grade Protein Stabilizers
Jason Forbes, Larry Lonski, Chris Wilcox
Sucrose, Trehalose, Mannitol, and Maltose are four of the most commonly utilized carbohydrates for protein stabilization in drug formulations. As the demand for parenteral excipients continues to rise, the biopharma industry is considering guidance that would require more extensive analysis of a variety of minor constituents, including metals. Despite the high purity of many of these excipients, it is important for manufacturers to have an understanding of non-sugar moiety profiles and how they may vary with raw materials and processing. Herein, we present results of validated metal analysis performed on Pfanstiehl’s injectable grade platform excipients. Specifically, multiple lots each of trehalose, sucrose, mannitol, and maltose were tested for levels of V, Cr, Mn, Fe, Ni, Cu, Zn, As, Mo, Ru, Rh, Pd, Cd, Os, Ir, Pt, Hg, and Pb. Observations from the data and proposed next steps are discussed.