Disrupting the Industry through Implementation of Pharma 4.0 Technologies

Manufacturing has been paid dividends for many years through the use of quality tools such as statistical process control, quality function deployment, vendor audit management, hazard analysis critical control points (HACCP), value stream analysis, and other valuation methods. In the highly regulated industries that manufacture pharmaceuticals, foods, and cosmetics, the quality control ‘scientists’ have been typically known to perform sampling and testing for determining the acceptability of finished products. During the past decade, the pharmaceutical industry has seen a significant regulator-industry aligned paradigm change and an important leap into the formality of quality improvement using quality tools. The paradigm of final product testing (and the myth of ‘testing quality into products’) has been challenged by both the industry and regulators. Recent industry and regulatory support of ‘risk-based’ concepts and principles are intended to produce a ‘desired state’ of industry development and production of pharmaceuticals that have a higher level of consistency in meeting purity, safety, and efficacy than in prior history.

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.

Concentration/Ultra-filtration (CUF) membranes are used extensively in biopharmaceutical operations. A typical purification platform may incorporate two to six CUF steps though out the downstream process.

In this webinar, the validation of an interactive response technology (IRT) solution built with configurable parameters will be explored. Traditionally, interactive response technology solutions require validation of each study-specific requirement to ensure proper implementation. With the prevalence of configurable interactive response technology solutions where the validation of each configurable parameter occurs within the product, the need for full validation of each requirement within a clinical study has lessened. This webinar will explore how to take advantage of configurations and how to verify them, thereby reducing the effort and timeline required for validation while still maintaining quality within each study.