Analytical Development & TestingTherapure operates under the principle, ‘Start with us,

stay with us,’ meaning that we provide a range of services

to our clients minimizing logistics and creating one point

of contact.

Supporting every successful drug development program

are 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 for your method development, qualification

and validation needs? Therapure is your trusted partner

for developing and validating analytical methods.

Therapure understands the importance of

your critical methods and how they support

your unique program.

Our facility has 10,600 ft2 of fully equipped analytical

development and quality control testing space. Our

analytical development and quality control teams have

extensive experience in the development, qualification,

and validation of cGMP compliant analytical methods,

including complex biological activity assays.

Immediately following project kick-off, our analytical

development team begins transferring your established

assays or developing products specific assays from

scratch. Prior to product manufacturing, the analytical

methods are transferred to Therapure’s Quality Control

department where they are qualified (for Phase I-II

Clinical programs) or validated (for Phase III/Commercial

programs) through mutually approved protocols.

Analytical Development & Testing

Our experience in method development, optimization, qualification and validation includes:

Physiochemical analysis

Raw material methods (custom or compendial)

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

Protein concentration (UV-Vis, fluorescence)n Spectrophotometry

n Nephelometry

n Colorimetric

Gel electrophoresisn SDS-PAGE

n IEF

n 2-Dimensional

Flow cytometry

ELISA

Cell based bioassays

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

n Specialized

Total organic carbon

Gas chromatography (headspace & liquid)

Microbiological testingn Microbial identification

n Endotoxin analysis (gel clot)

n Particulate matter

n Sterility

n Bioburden

Protein characterizationn Amino acid analysis

n Peptide mapping and glycoform analysis

n Extinction coefficient studies

n Liquid chromatography mass spectroscopy (LC-MS)

Blood/plasma testingn 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 partner for contract protein development & manufacturing