Pfizer’s Warp Speed Adoption of Celsis® for Their Sterile Injectable
The Celsis® complete validation support package helped reduce Pfizer’s timeline from concept to regulatory approval from a few years down to just nine-and-a-half-months, a record-setting achievement in pharma.
Our rapid detection systems feature amplified ATP-bioluminescence technology, generating more accurate and faster sterility testing results than traditional methods, which helped Pfizer release their sterile injectable faster and more safely to the public. Their story is captured through Joanny Salvas’ presentation from the 2021 PDA Pharmaceutical Microbiology Conference.
AstraZeneca Builds Multi-Product RMM Validation Strategy with Celsis®
For AstraZeneca to structure their RMM implementation for rapid sterility, they first needed a strong foundation. We supported their efforts by providing method equivalency data which laid the groundwork for their entire validation plan.
AstraZeneca’s Miriam Guest described their experience leveraging method equivalency data and executing a robust testing plan to test in presence of product during the 2021 PDA Pharmaceutical Microbiology Conference. This approach allowed AstraZeneca to confidently build their validation plan and use a multi-product strategy to expand their implementation across their product portfolio.
Roche Diagnostics’ Success and Plans for Global Deployment of Celsis®
Roche Diagnostics partnered with us to implement Celsis® to support their rapid sterility testing goals. Working closely and setting a new standard for vendor and end-user collaboration, Roche’s Sven Deutschmann and Jonas van den Berg describe how they were able to speed up the process significantly when validating their new rapid microbiological method.
Innovating their quality control in laboratory with rapid microbial testing allowed them to release their product seven days earlier than the traditional method they had used previously and receive approvals from regulatory authorities around the world. This method has become so favorable in their lab that they’re preparing to deploy the method globally across other sites.
Boehringer Ingelheim’s experience evaluating Celsis for Short Shelf Life Products
Boehringer Ingelheim’s Rapid Microbiological Methods group recently shared their experience during beta-testing with the recently launched Celsis Adapt™ sample concentrator system for use with cell-containing samples. Overcoming a challenge for rapid microbiological methods, the system effectively filtered background cells during the sample preparation phase, proving that ATP-bioluminescence rapid microbial testing method has the potential to be used for cell-based samples such as cell banking, ATMPs, and in-process cell culture sample testing.
Johannes Oberdorfer, Lead Scientist for Rapid Microbiological Methods at Boehringer Ingelheim presented his findings at the 2021 PharmaLab Congress and discussed both the challenges faced and the benefits of using this platform.