The pharmaceutical industry is moving towards custom devices to provide more value-added features for patients and end-users. With this shift, it is critical that manufacturing partners can offer a comprehensive spectrum of services related to device manufacturing from design and development, clinical studies, combination drug product handling, commercial combination product assembly, and packaging from clinical builds to high volume commercialization. Contract manufacturers with a full spectrum of services are better positioned to allow their pharmaceutical partners to simplify vendors and, subsequently, their supply chain, resulting in the need for fewer quality and regulatory validations, as well minimizing cargo hold-ups by requiring less overall transportation.
To maintain the integrity of drug products and minimize the introduction of counterfeit drugs in the marketplace, cold chain storage and serialization/aggregation are increasingly required. As the Drug Quality and Security Act (DQSA) is phased into manufacturing operations, contract manufacturers will be required to implement unit-level traceability into their manufacturing processes within the next few years. To ensure the highest quality operations, manufacturers with mature serialization and cold chain storage infrastructure are best positioned to provide the pharmaceutical industry with safe, timely products.
At Phillips-Medisize, a Molex company, our quality management systems are the backbone of our business, governing all we do regarding drug handling and even plastics molding, from temperature-controlled storage to automated process assembly to serialization. We will discuss how we married the requirements of DQSA and the needs of the pharmaceutical industry into our legacy of quality manufacturing to create the infrastructure to provide multiple facets of drug-device/combination product manufacturing, including cold chain storage and serialization.
Becky Anderson, Principal Pharma Engineer, Phillips-Medisize, a Molex Company
As Principal Pharma Engineer, Becky Anderson plays a leading role in Phillip-Medisize’s drug and reagent handling services. With over 20 years of experience in FDA-regulated environments, including powder handling and aseptic filling, Becky provides expertise in fill/finish, assembly and drug product handling operations.
Becky also has a strong project management background and leads cross-functional teams in highly automated and regulated manufacturing environments. She earned a Master’s degree in Technology Management and a Bachelor’s degree in Manufacturing Engineering from the University of Wisconsin-Stout.
Brian Ehret, Solutions Architect, Phillips-Medisize, a Molex Company
Brian Ehret leads the Solutions Architect team responsible for Phillips-Medisize’s serialization services, working with customers to understand their unique technology-related needs from networked line equipment, data collection and analysis through packaging serialization and cloud-based connectivity. For each customer’s unique serialization requirements, Brian and his team are able to design, deploy and manage standard or customized solutions, ensuring full integration of customer data needs with Phillips-Medisize technology design and validation requirements at any of their global facilities.
Growing up on a farm in Minnesota, Brian’s passion has always been discovering and designing solutions that add value, which has led to many opportunities for learning and using that knowledge for unconventional problem resolutions. After receiving a Masters of Physics in superconductivity research, Brian has leveraged his learning, understanding and resourcefulness in the IT field, where he has worked now for over 25 years. Brian’s passion also extends to his personal life where, with his family, he operates the farm he grew up on in a sustainable and regenerative way.
Who Should Attend?
This B2B webinar will appeal to pharmaceutical and medical device companies and job functions, including but not limited to:
- Pharmaceutical companies in the injection market
- Pharmaceutical product development managers
- Sustainability leaders and supply chain managers in the pharmaceutical industry
- Pharmaceutical device engineers engaged in technology selection (R&D/Supply)
What You Will Learn
- Challenges in developing drug-device combination products
- How to meet serialization requirements from regulators
- Achieving successful high-volume commercialization of combination products
Phillips-Medisize, LLC, a Molex company, is an end-to-end provider of innovation, development and manufacturing solutions to the pharmaceutical, diagnostics and medical device market segments. Backed by the combined global resources of Molex and its parent company Koch Industries, Phillips-Medisize’s core advantage is the knowledge of its people to integrate design, molding, electronics, and automation, providing innovative, high-quality manufacturing solutions.