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Analytical Development& Testing

Therapure operates under the principle, Start with us,

stay with us, meaning that we provide a range o services

to our clients minimizing logistics and creating one point

o contact.

Supporting every successul drug development programare reliable and robust analytical methods. These methods

must be designed to support in-process analysis, bulk

release testing, drug product release testing and stability

monitoring programs. Who can provide the required

support or your method development, qualifcation

and validation needs? Therapure is your trusted partner

or developing and validating analytical methods.

Therapure understands the importance oyour critical methods and how they support

your unique program.

Our acility has 10,600 t2 o ully equipped analytical

development and quality control testing space. Our

analytical development and quality control teams have

extensive experience in the development, qualifcation,

and validation o cGMP compliant analytical methods,

including complex biological activity assays.

Immediately ollowing project kick-o, our analytical

development team begins transerring your established

assays or developing products specifc assays rom

scratch. Prior to product manuacturing, the analytical

methods are transerred to Therapures Quality Control

department where they are qualifed (or Phase I-II

Clinical programs) or validated (or Phase III/Commercial

programs) through mutually approved protocols.

Analytical Development & Test

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Our experience in method development, optimization,

qualication and validation includes:

Physiochemical analysis

Raw material methods (custom or compendial)

Compendial methods (USP, Ph. EU, JP, NF)

Protein concentration (UV-Vis, fuorescence)

n Spectrophotometry

n Nephelometry

n Colorimetric

Gel electrophoresis

n SDS-PAGEn IEF

n 2-Dimensional

Flow cytometry

ELISA

Cell based bioassays

High perormance liquid chromatographyn Standard (SEC, RP, Ion Exchange)

n Specialized

Total organic carbon

Gas chromatography (headspace & liquid)

Microbiological testing

nMicrobial identifcation

n Endotoxin analysis (gel clot)

n Particulate matter

n Sterility

n Bioburden

Protein characterization

n Amino acid analysis

n Peptide mapping and glycoorm analysis

n Extinction coefcient studies

n Liquid chromatography mass spectroscopy (LC-MS)

Blood/plasma testing

n Nephelometry

n HemoX (P50) analysis

n Co-oximetry

n Phospholipids

Therapure Biopharma Inc.2585 Meadowpine Boulevard,

Mississauga, Ontario Canada L5N 8H9

Telephone: +1 905 286 6200

Fax: +1 905 286 6300

www.therapurebio.com

your trusted partnerfor contract protein development & manufacturing