Sterile injectable product formulations—ranging from biologics and small molecules to compounded preparations—are increasingly complex and tailored to meet specific therapeutic needs. Many require rapid turnaround times for critically ill patients, adding pressure to ensure safety without delay. The unique nature of these products presents significant challenges in quality control and regulatory compliance. To ensure the sterile injectable products are free from microbial contamination, pyrogenic substances, and sub-visible particles that could pose risks to patient health, they must meet stringent safety standards.

Establishing a successful partnership with a qualified testing provider is critical to navigating these challenges. Such collaboration ensures that appropriate methods are implemented effectively, testing is performed under compliant conditions, and products reach patients safely and swiftly.

Ultimately, balancing the urgency of patient needs along with the rigor of pharmaceutical testing demands a strategic approach—one that embraces innovation while upholding the highest standards of quality and compliance.

In this webinar, we will discuss:    

• Understand compendial testing requirements for sterility testing, bacterial endotoxin testing, and sub-visible particulate matter testing—and what your testing partner needs to know.
• Identify key attributes of a successful partnership that supports compliance and efficiency.
• Explore critical factors when selecting and outsourcing to a testing lab.
• Review current regulatory expectations for both pharmaceutical manufacturer and testing providers.

Presenters:

	Zachary Beck Microbiology Group Leader Eurofins BioPharma Product Testing
Zachary Beck is a Group Leader in the Bio/Pharmaceutical Microbiology department at Eurofins BioPharma Product Testing and oversees particulate matter and sterility testing. In this role, he assists clients in designing, planning, and executing their testing to meet compendial requirements, using his knowledge and expertise to ensure the client’s needs and regulatory requirements are met. He joined the Eurofins team as a Microbiologist in 2011. Since then, he has performed testing and accumulated knowledge across the microbiology field, including organism identification, microbial limits testing, anti-microbial effectiveness testing, sterility testing, and particulate matter testing. He earned his Bachelor’s of Science in Biology from York College of Pennsylvania.
	Michael Hostetter Senior Scientist Eurofins BioPharma Product Testing
Michael Hostetter is a Senior Scientist I in Bio/Pharmaceutical Microbiology at Eurofins BioPharma Product Testing. With 8 years of experience, he specializes in bacterial endotoxin testing, contributing to pharmaceutical safety and quality through rigorous microbiological analysis. Michael earned his Bachelor of Science in biology and microbiology at Penn State.

Moderator:

	Morgan Newell Regional Sales Manager – Northwest Eurofins BioPharma Product Testing
Morgan Newell is the Northwest Regional Sales Representative at Eurofins BioPharma Product Testing. In this role, Morgan functions as a key point of contact, guiding clients through the Eurofins network and ensuring seamless access to Eurofins’ comprehensive testing services. Morgan holds a bachelor’s degree in chemistry from Pennsylvania State University.