Grand River Aseptic Manufacturing (GRAM) is an ISPE Facility of the Year award winning sterile injectable Contract Development and Manufacturing Organization (CDMO). GRAM grew rapidly over the last two years as they brought on a world-class aseptic filling facility and state-of-the-art finishing center.
Watch this webinar to hear about the collaboration that helped optimize their new filling line with single-use needles and reduced downtime.
The presentation from GRAM, Bausch+Ströbel, and Pall Corporation will cover:
- The latest industry trends for final filling
- The benefits of filling lines with single-use filling assemblies
- Data to show how optimizing needle can affect filling accuracy
- How GRAM reduced downtime
- Questions and answers session
MSAT Process and Product Support Specialist, Grand River Aseptic Manufacturing
Paul holds an integral role in the Manufacturing, Science, and Technology (MSAT) department at Grand River Aseptic Manufacturing (GRAM). He is an expert on GRAM’s modern sterile filling equipment and technology, which includes a Bausch + Ströbel vial filler with SKAN isolator and IMA lyophilizer. His talents made an impact when GRAM was called upon by the United States Government to support Operation Warp Speed and COVID-19 pandemic response. Paul was on the front line when GRAM sped up operational readiness by six weeks to provide fill/finish services for a SARS-Cov-2 vaccine.
Research Engineer, Bausch+Ströbel
Tim is a Research Engineer in the Research and Development Department at Bausch+Ströbel. After completing his mechatronics engineer degree in 2013, he joined the R&D team at Bausch+Ströbel right away.
Since then, he has made significant contributions to several developments in the pharmaceutical engineering environment and showcases 8 years of experience in the development of pharmaceutical filling and closing technologies. He is currently completing his additional studies as an industrial engineer with focus on Industry 4.0 technologies.
In order to find the best possible filling process solution for single-use equipment, Tim carries out a wide variety of dosing tests in the Bausch+Ströbel research laboratory or at the customer's site. He and his team continuously improve and develop groundbreaking technologies to redefine the boundaries of pharmaceutical filling
Product Manager, Pall Corporation
Delphine is responsible for the planning and execution of strategy for Pall Biotech’s Single-Use Final Filling Assemblies portfolio, ensuring that Pall develops the single-use systems our customers need to achieve their objectives during the development and manufacture of drug product.
Delphine joined Pall in 2001 and prior to her current position, held important training and technical support roles of increasing responsibility. Through her experience she has attained a comprehensive knowledge of biopharmaceutical production, extensive practical experience of sterile filtration, and a deep understanding of drug product and fill finish applications.
She holds a master’s degree in biotechnology from the University of Compiègne, France.
Why the introduction of X-ray sterilization technology is a critical change for single-use industry, and how gamma and X-ray irradiation compare
The market demand for gamma irradiation, the current primary method for the sterilization in SUT, will soon significantly exceed supply, creating an urgent need for alternatives.
Join Christelle Marcoux from GSK Vaccines (BioPhorum workstream member on alternatives to gamma sterilization) and James Hathcock, PhD of Pall Corporation (Bio-Process Systems Alliance X-Ray Committee Co-Chair) as they discuss the introduction of X-ray sterilization technology.
You will learn more about:
- Why this is a critical change for industry and the responsibilities of each stakeholder
- Key questions to address for biomanufacturers
- How gamma and X-ray irradiation compare
- What testing has been completed and key milestones for readiness for industry
- An example of how to qualify a SUS sterilized with X-ray irradiation