It’s our mission to share our cold chain validation best practices that will help industry leaders understand the changing industry standards and how to integrate risk management processes with validation best practices to ensure compliance, quality, and product integrity,” said Gary Hutchinson
HOUSTON (PRWEB) October 29, 2019
Modality Solutions, a biopharmaceutical cold chain engineering firm, is pleased to announce its Silver sponsorship and cold chain validation workshop at the Biomanufacturing World Summit (BMWS19) Conference, November 11-12, 2019, at the Hilton La Jolla Torrey Pines in San Diego, California.
The Biomanufacturing World Summit brings together pharmaceutical executives, cutting-edge technology providers, and media partners for North America’s premier biologics event. The 2-day conference will focus on the patient as biopharmaceutical companies strive to improve the quality, efficacy, cost, and compliance of their life-saving products.
Modality Solutions’ principals Gary M. Hutchinson and Daniel J. Littlefield will present “Cold Chain Validation Best Practices Including Immunotherapy” on Monday, November 11, at 2:35 p.m. PT in Breakout Room 3. During the session, attendees will take away valuable information including:
- Review of recent FDA feedback on immunotherapy submissions
- Understanding damage boundaries for therapies
- Defining your operating space for transportation hazards
- Putting it all together: Cold chain validation strategies for monoclonal antibodies, antibody-drug conjugates, and cell therapies
Modality Solutions is a biopharmaceutical cold chain engineering firm that has extensive experience with cold chain validation, transport simulation testing, thermal packaging qualification and the regulatory filing approval process. The firm works on a project basis or can integrate its professionals with your team.
“Our sponsorship and workshop at the BMWS19 support our continued commitment to helping the global biopharmaceutical industry grow and evolve,” said Modality Solutions President Gary M. Hutchinson. “Today, more than ever, with complex regenerative medicine therapies, the biopharmaceutical industry is faced with the pressure to focus on the patient as they improve the quality, efficacy, and compliance of their life-saving products. It’s our mission to share our cold chain validation best practices that will help industry leaders understand the changing industry standards and how to integrate risk management processes with validation best practices to ensure compliance, quality, and product integrity.”
Executive Platforms is the BMWS19 conference producer. It facilitates the sharing of ideas among the senior leadership of businesses and organizations with shared objectives, interests, and challenges. With decades of experience, EP works to elevate the conversation and provide all its stakeholders with a trusted platform to network, benchmark, learn, and grow together to inspire success in their working lives.
For more information or to register for the BMWS19, go to https://www.biomanworld.com.
To learn more about Modality Solutions, visit https://www.modality-solutions.com.
About Modality Solutions, LLC
Founded in 2011, Modality Solutions, a biopharmaceutical cold chain engineering firm, specializes in integrating cold chain operations, developing transport validation strategies, supporting global regulatory applications, and supporting clinical trial operations globally. By combining the best practices of process validation, systems qualification, and risk assessment, Modality Solutions has earned the reputation of ensuring regulatory compliance, product quality, and patient safety. As an Inc. 5000 verified company and Houston Business Journal Fast 100 company, Modality Solutions’ team of engineers are experts at delivering cold chain thermal packaging design and qualification, conducting transport simulation testing, and controlled-environment logistics solutions. For more information, visit https://www.modality-solutions.com.