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(s) in a patient that has a corresponding protein deficiency or abnormality, augment an existing pathway, or provide a new function entirely, among other capabilities. Manufacturing protein-based therapeutics can be challenging because the protein molecules are inherently unstable, and the molecules have a propensity to aggregate together to form larger protein particles. This instability increases when molecules are exposed to stresses during manufacturing, shipping, storage, and even patient administration. Protein aggregates can have a dramatic effect on drug efficacy and patient safety.
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 translucent, low-contrast inherent product particles due to refractive index-matching issues. Orthogonal methods such as Flow Imaging Microscopy (FIM), Microfluidic Imaging (MFI), and Backgrounded Membrane Imaging (BMI) do not suffer from these refractive-index-matching limitations. Each of these methods is identified as an orthogonal method to LO for drug lot release. These imaging-based methods provide information on particle size and count, but they lack robust algorithms capable of analyzing the unique textural and morphological features embedded within images of protein aggregation.
ParticleSentryᴬᴵ software uses Artificial Intelligence and computational statistics together to provide actionable, quantitative information from these orthogonal methods. For the first time, formulation development scientists can use a supervised learning approach to quantitatively determine if a collection of protein aggregate images match a known stressor condition or represent a new outlier condition - all with statistical certainty! Combine ParticleSentryᴬᴵ with Yokogawa's FlowCam® + LO, and with a single instrument and one sample, meet today's 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 solution from SentrySciences since our founding over 10 years ago.
San Diego, CO
Glenn Brandon will be speaking at the SLAS2023 International Conference and Exhibition Feb. 25 - Mar. 1 in San Diego, CA.
The title will b...
San Diego, CO