Featured Case Study
Reduce Process Variability
A leading Pharmaceutical company was struggling with process variability in a complex step in their manufacturing process of a product that generated $3B of revenue annually. This variability led regulatory inspectors to question the company’s specification limits and their ability to manufacture the product reliably.
- Human Genome Sciences: Aegis Discoverant for Emerging Biotechnology Companies
Human Genome Sciences (HGS) is committed to solving critical medical challenges through careful planning, relentless resilience, the best scientific minds, and rigorous clinical trials. For the company, success comes by design – and by working systematically to achieve breakthrough results one careful step at a time. HGS’ manufacturing and process development capability represents a significant strategic advantage. The company is able to produce and purify multiple protein and antibody drugs in two state-of-the-art process development and manufacturing facilities – totaling approximately 400,000 square feet and offering both small-scale and large-scale production.
- Merck Serono Discovers the Value of Process Improvement
Gartner analyst, Wayne McDonnell, spoke with Merck Serono’s EVP of Operations, Dr. Hanns-Eberhard Erle, and their Scientific Director of New Technologies, Dr. Gianni Baer, about Merck Serono’s experience using Discoverant, Aegis Analytical’s Enterprise Manufacturing Intelligence software.
- Managing Virtural Manufacturing Networks - A Sponsor Perspective
Outsourcing your manufacturing can provide flexibility, accelerate time to market, reduce CAPEX costs and leverage the specialized manufacturing operations of third parties. However, maintaining visibility into your processes and process data and protecting your manufacturing intellectual property is challenging when relying on third parties around the world.
- Contract Manufacturers Enhancing Their Sponsor Relationships
Contract Manufacturing Organizations (CMOs) strive to meet their customers’ needs at a competitive price while also meeting FDA product and quality requirements. To achieve a predictable process and supply chain and consistent product quality, CMOs and their customers need to establish a transparent data window for better collaboration, analytics and reporting. However, disparate manufacturing data systems, spreadsheets and paper-based reports and geography often make these goals difficult to achieve.
- Improving Process Predictablity Across Multiple Plants
A multinational Pharmaceutical company was trying to gain control over process predictability for two of their blockbuster products.
- Streamline Annual Product Reviews
An international company with a broad line of products in Consumer Packaged Goods, Pharmaceutical and Biotechnology wanted to improve their ability to access and analyze manufacturing process data on-demand in order to improve efficiency.
- Improve Process Understanding, Stability and Product Quality
A large Biotech company was experiencing production issues with two flagship products, and struggling to identify the root causes. They wanted to improve their process understanding to identify the critical process parameters.
- Reduce Process Variability
A leading Pharmaceutical company was struggling with process variability in a complex step in their manufacturing process. This variability led regulatory inspectors to question the company's specification limits and their ability to manufacture the product reliably. The product generated over $3B of revenue annually so it was critical to find a solution.