Protein therapeutics show significant promise in improving the lives of persons with various forms of cancer, HIV, and other diseases. These life-saving drugs can replace a protein in a patient that is deficient or abnormal, augment an existing pathway, or provide a new function entirely, among other capabilities. Production of protein-based therapeutics can be challenging because of their inherent instability and propensity to aggregate when exposed to stresses during manufacturing, shipping, storage and even patient administration.
Detecting, Identifying, and Controlling unwanted sources of contamination in injectable protein drug products requires a multi-tool approach that focuses on the product, but also the manufacturing equipment and environment. SentrySciences has the expert knowledge, products and personnel to help detect sub-visible particles in biologic drug products and to comply with USP<787> Sub-visible Particles in Protein Therapeutic Injections and USP<788> Particulate Matter in Injections. We can help you identify and quantify protein aggregation and develop strategies to control it in your drug product.
At SentrySciences, we understand the analytical challenges of compliance with USP<787> and USP<788> requirements for sub-visible particulates. Light Obscuration (LO), currently the only approved compendial method for sub-visible particle testing for injectable drug lot release, is significantly challenged by inherent protein particles. The LO method has technical limitations that result in under-counting and under-sizing of translucent, low-contrast inherent product particles due to refractive index-matching issues. Orthogonal methods such as Flow Imaging Microscopy and Background Membrane Imaging do not suffer from these refractive-index-matching limitations. These imaging-based methods provide quantitative information for particle size and count, but they lack a robust algorithm capable of analyzing the unique textural and morphological features embedded within images of protein aggregation.
ParticleSentryᴬᴵ by SentrySciences is a revolutionary approach that uses Artificial Intelligence and computational statistics together to provide actionable, quantitative information from protein aggregate images. For the first time, formulation development scientists can use a supervised learning approach to quantitatively determine if a collection of protein aggregate images indicates an unknown process upset or matches a known stressor condition with statistical certainty. Combine ParticleSentryᴬᴵ with Yokogawa's FlowCam + LO, and with a single instrument and one sample, meet todays requirements of USP<787>, USP<788>, add orthogonal flow imaging microscopy and data analysis powered by AI from SentrySciences.
Because they are injections, protein therapeutics are subject to the same GMP and related quality regulations that apply to small and large molecule parenteral products. Fortunately, providing and installing validated total particle, viable particle, and environmental monitoring systems in aseptic fill-finish environments has been a core business at SentrySciences since our founding over 10 years ago.