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Bio Analytical Development and Testing

Therapure provides analytical development and testing services including developing and validating analytical methods. They have a fully equipped facility and experienced teams for transferring, qualifying, and validating assays to support drug development programs.

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Thomas Wellner
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49 views

Bio Analytical Development and Testing

Therapure provides analytical development and testing services including developing and validating analytical methods. They have a fully equipped facility and experienced teams for transferring, qualifying, and validating assays to support drug development programs.

Uploaded by

Thomas Wellner
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Analytical Development & Testing

Analytical Development
& Testing
Therapure 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.
Our experience in method development, optimization,
qualification and validation includes:

Physiochemical analysis High performance liquid chromatography


n Standard (SEC, RP, Ion Exchange)
Raw material methods (custom or compendial)
n Specialized
Compendial methods (USP, Ph. EU, JP, NF)
Total organic carbon
Protein concentration (UV-Vis, fluorescence)
Gas chromatography (headspace & liquid)
nS
 pectrophotometry
n Nephelometry Microbiological testing
n Colorimetric n Microbial identification
n Endotoxin analysis (gel clot)
Gel electrophoresis
n Particulate matter
nS
 DS-PAGE
n Sterility
n IEF
n Bioburden
n 2-Dimensional
Protein characterization
Flow cytometry
n Amino acid analysis
ELISA n Peptide mapping and glycoform analysis
n Extinction coefficient studies
Cell based bioassays
n Liquid chromatography mass spectroscopy (LC-MS)

Blood/plasma testing
n Nephelometry
n HemoX (P50) analysis
n Co-oximetry
n Phospholipids

your trusted partner


for contract protein development & manufacturing

Therapure Biopharma Inc.


2585 Meadowpine Boulevard,
Mississauga, Ontario Canada L5N 8H9

Telephone: +1 905 286 6200


Fax: +1 905 286 6300

www.therapurebio.com

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