Presented By:

celsis®

RAPID MICROBIAL DETECTION
ABOUT THE SPEAKER

Jonathan (Jon) Kallay is a Senior Technical & Market Development 

Manager working remotely for the Microbial Solutions product 

lines. He is a subject matter expert on microbiological investigations 

for manufacturing facilities that make regulated products. Jon 

provides practical laboratory experience to help clients identify the 

optimal path forward for their labs.

Jon received his Bachelor’s degree in biochemistry from Denison 

University before earning a post-graduate diploma in pharmaceutical 

microbiology from the University of Manchester.

Jonathan Kallay

Senior Director of 

Technology and Market 

Development
Presented By:

celsis®

RAPID MICROBIAL DETECTION
Sterility Test Flow with Celsis

Sterility Testing Incubation Reading Results

Same day Transfer 14 Day Incubation 6 Day Incubation
5 EVERY STEP OF THE WAY

CELSIS AMPISCREEN®

AMPLIFIED ATP BIOLUMINESCENCE

Celsis® ATP-Bioluminescence Reagents

• Two-phase, proprietary enzyme reaction

• All living organisms also contain the enzyme 

adenylate kinase (AK) as part of their 

biochemical processes 

• Microbial enzymes convert ADP into ATP

• Amplification of ATP levels beyond naturally 

occurring level.

• Enzymes are not depleted by reaction 

• Ability to generate almost unlimited amounts of 

ATP Intracellular

ATP and 

components 

extracted

Contaminated 

sample

Celsis LuminEXTM & 

Celsis LuminAMPTM

Added

Celsis 

LuminATE® 

added

50 uL sample

AMPLIFIED light 

signal generated
Celsis® Complete Validation & 

Reports

Method Validation documentation for 

Equivalency, Specificity, Robustness, 

Ruggedness, and Limit of Detection.

cGMP Validation Testing in Presence of 

Product for Method Suitability, Equivalency, 

Limit of Detection, Specificity. 

Product Code: VAL6000MF

Celsis® Advantage 

Reports & Protocols

Method Validation documentation for 

Equivalency, Specificity, Robustness, 

Ruggedness, and Limit of Detection.

Protocols for Testing in Presence of Product 

for Method Suitability, Equivalency, Limit of 

Detection, Specificity. 

Product Code: VAL6100MF

CELSIS ADAPT

Demonstrated detection of 

broad range of microorganisms, 

including fungi.

Celsis AdaptTM Introduction

Aligns with current and new 

regulatory requirements for the 

use of alternative rapid 

microbiological methods. 

Compatible with various cell 

lines used in bioprocessing of 

pharmaceuticals and cell & 

gene therapies.
Sterility Test Flow With Celsis Adapt

Reading Results Product Cell Removal

Same day Testing
CELSIS ADAPTTM PREP PROCESS OVERVIEW 

Celsis AdaptTM Methodology & Workflow

 Load samples into 

Celsis Advance IITM

 Allow 20-minute ATP 

depletion step 

 Obtain rapid qualitative 

results reported in 

positive or negative

EVERY STEP OF THE WAY - CONFIDENTIAL -

3-7 DAYS 20+ MINUTES

10

 Prepare sample 

using compendial 

method TSB/FTM 

media used 

 Incubate for 3-7 

days 

Prepare & 

Incubate

 Combine aliquot of 

concentrate and 

reagent to sterile assay 

cuvettes.

Pipette Concentrate + 

Celsis LuminASE®

Run on 

Celsis® instrument

 Aseptically remove 

sample aliquot and add 

to Treatment Solution

 Allow for a minimum 

dwell time of 15 

minutes

 Concentrate using 

AdaptTM

Lyse & 

Concentrate

15 minutes 20 minutes < 60 minutes

or
REDUCTION OF ATP BACKGROUND

Background of 10 mL Cell Sample (CHO, 1x106 / mL) + 100 mL TSB/FTM

11 EVERY STEP OF THE WAY 
STEM CELLS METHOD SUITABILITY (PH. EUR. 2.6.27)

1 mL Human Umbilical Stromal Cells (5x106 / mL) and Supernatant + 100 mL TSB/FTM, 7 Days Incubation

EVERY STEP OF THE WAY - CONFIDENTIAL -

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149130

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50047

652

3418272

62322

1889787212360569

5688934

24011603

90225

366

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138950

1

10

100

1000

10000

100000

1000000

10000000

100000000

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Supernatant

A. brasiliensis

B. subtilis

C. albicans

M. luteus

P. aeruginosa

S. aureus

S. pyogenes

Supernatant

C. acnes

C. sporogenes

Umbilical Stromal

A. brasiliensis

B. subtilis

C. albicans

M. luteus

P. aeruginosa

S. aureus

S. pyogenes

Umbilical Stromal

C. acnes

C. sporogenes

TSB FTM TSB FTM

Supernatant Umbilical Stromal

12
CELSIS DATA AND VALIDATION SUPPORT

EVERY STEP OF THE WAY 13
CONTACT US

Jon Kallay

Senior Technical and Market Development Manager

Jonathan.kallay@crl.com

Address:

251 Ballardvale Street

Wilmington, MA

01887

Website: 

www.criver.com

Email:

askcharlesriver@crl.com

Phone:

877.CRIVER.1