6th Annual Pharmaceutical Microbiology USA Conference
Boston, MA, USA
Sponsored by: LONZA
Chaired by: Donald Singer, USP General Chapter Committee Microbiology Chair, US Pharmacopeia
Contamination Control and Microbial Methods Explored to Assure Product Quality and Prevention
Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches.
Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors is also sustaining new growth and transformation in this field. The regulatory landscape is changing, firstly with the preparation of Annex I, in addition to increasing requirements pertaining to data integrity. Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.
On top of this, the developing integration of automation and robotics into the manufacturing pipeline, as well as the increased need for more rapid microbiology methods brought about in part by the surge in ATMPs, are all highlighting the necessity of the field in Pharma.
This industry is ever expanding, join our leading experts at the 6th Annual Pharmaceutical Microbiology East Coast Conference in Boston, USA to discuss and analyse the latest advances and challenges surrounding Pharmaceutical Microbiology. Network with the industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insights.
Event Hashtag: #MicrobiologyUSA
Key Conference Highlights:
- Review implementation guidance and validation for efficient microbial testing programs
- Uncover how to implement effective contamination control for manufacturing and the impact throughout pharmaceutical microbiology
- Learn how to control mold contamination and apply risk-based tools to tackle recovery
- Delve into the role the microbiologist plays in bioburden assessments and holistic closure integrity testing for new drug modalities
- Understand innovative techniques to control contamination as it relates to cell therapy products, combination, and traditional microbiological drug products
View the full agenda: http://www.microbiologyeastcoast.com