Optimising contamination control
Minimising the risk of microbial contamination requires careful planning, operation, equipment and process decisions as part of an overarching contamination control strategy. This session will discuss some state-of-the-art approaches to establishing and innovating contamination control, including:
Transforming endotoxin testing
Endotoxin testing is a crucial element of pharma companies’ contamination control strategies, with significant patient safety, product quality and manufacturing process implications. Amid growing pressure on pharma manufacturers to take a more sustainable approach to their endotoxin tests and drastically reduce their reliance on finite natural resources, this session will discuss:
Modernising environmental monitoring
Waves of pharmaceutical product innovation require environmental monitoring approaches that can advance in lockstep with the increasing range of emerging modalities and advanced therapies. Amid this progress, traditional environmental monitoring practices and processes are also in need of updating, with novel tools and technologies an often untapped resource. This session will discuss:
Amala Saju
Amala Saju is a regulatory affairs professional experienced in Chemistry, Manufacturing, and Controls (CMC) across global pharmaceutical companies, including Pfizer, Novo Nordisk, and currently, Sanofi. Her expertise lies in CMC technical writing focused on pharmaceutical manufacturing processes, quality control, and product specifications to support global regulatory submissions and compliance. She has contributed to over 100 […]
Bio Rad
James Heindl
Jim has been at the Thermo Fisher Scientific / Patheon Cincinnati site since 2000. By training he is a Chromatographer, earning his PhD in Separation Science in 1998 from the University of Cincinnati under the guidance of Dr John Dorsey. He began his career on the bench as a lead development chemist then progressed to […]
Miriam Guest
Miriam Guest is the Senior Principal Scientific Advisor of Microbial Solutions. She recently joined the organization after 20 years with AstraZeneca. In her role, she provides scientific governance and strategic direction. She has extensive experience in the pharmaceutical Industry leading contamination control strategies for drug development projects as well as supporting internal and external manufacturers […]
Meghan Provenzano
Bio coming soon
Rajasekhar Reddy Poonuru
Bio coming soon
Sana Shamim
Sana Shamim is an experienced medicinal chemist with interest in computational chemistry, nanoparticles synthesis and characterization, medicinal chemistry, metal complexes and analytical chemistry evident from her research. She has expertise in the field of organic synthesis, method development on both UV-Visible and RP HPLC and characterization instruments like FT-IR, H1NMR, Mass spectrophotometer, SEM, XRD and […]
