This eBook presents various techniques used to measure the stability of antibody-based biotherapeutics. The authors address the ins-and-outs of monoclonal antibody (MAb) formulation, cover Investigational New Drug (IND) and New Drug Application (NDA) filing timelines, and explain how storage conditions affect MAb stability. Monoclonal antibodies have been used in therapeutics for more than 30 years. Efforts to further develop and optimize better MAb-based biotherapeutics are increasing as they have become increasingly popular for the treatment and prevention of many diseases…

Future proof your HCP strategy. Four questions to help you decide if your HCP analysis data is ready for next phase approval. Host cell proteins (HCPs) are a primary source of impurities in biologics development. Scientists must detect and remove HCPs to ensure patient safety and meet regulatory guidelines. If previously undetected HCPs are found in later phases of clinical trials, scientists will need to redesign the drug substance purification strategy – adding financial and time costs that can create…

The stakes are high in biologics development, especially in host cell protein (HCP) analysis. Regulatory bodies have rules and suggested strategies for HCP analysis and reporting, and it is likely that removing HCPs is a key concern in your process development. Ultimately, the accuracy of monitoring and success of purifying your biologic of these HCPs can make or break your product. Get it wrong and it could delay your development cycle. In this blog, we outline strategies to optimize your…

Enzyme-linked immunosorbent assays (ELISAs) are critical to detecting and removing host cell proteins (HCPs), a primary source of impurities in biologics development. Scientists must validate HCP ELISAs to ensure patient safety and meet regulatory guidelines – but different coverage assays come with different challenges, limitations, and benefits. The US Pharmacopeia recommends 2D differential gel electrophoresis (DIGE) combined with Western blot or immunoaffinity approaches, and labs might not be able to gain the full benefits of DIGE without significantly altering current…

Host cell proteins (HCPs) are a primary source of impurity in biologics manufacturing. When present in drug formulations, HCPs can reduce efficacy, introduce toxicity, and increase risk of long-term immunogenicity. Understanding HCP profiles and integrating effective removal strategies are critical when developing a new biological drug, both for ensuring patient safety and fulfilling regulatory guidelines. HCP populations can be complex and structurally diverse, and most changes in upstream culture conditions affect HCP concentrations and control strategies. Accurate and reliable HCP…

Everybody has heard the axiom “time is money,” which highlights the belief that time is a valuable resource; therefore, it is better to do things as quickly as possible in order to make more money. This concept perfectly describes the current atmosphere within the biopharmaceutical industry, where drug manufacturers are struggling to overcome speed-to-market challenges in order to reap the financial benefits of an optimized patent window. In order to bring their products to market, most biopharmaceutical-manufacturing systems employ a…