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Custom Biologics

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Mississauga, Ontario, CA

About Custom Biologics

Founded: 2004 Type: Privately Held Size: 11-50 employees

Custom Biologics is Canada’s leading large molecule CRO providing custom bioassay design, validation and regulatory compliant testing.

Our Bioassay Group develops and validates custom assays to evaluate the therapeutic potential of biological macromolecules. Our bioassays are developed using the latest... Show more »

Custom Biologics is Canada’s leading large molecule CRO providing custom bioassay design, validation and regulatory compliant testing.

Our Bioassay Group develops and validates custom assays to evaluate the therapeutic potential of biological macromolecules. Our bioassays are developed using the latest technologies and employed for all phases of drug development, as well as GMP-lot release testing of biologics destined for the clinic.

All assays are designed to meet the latest regulatory guidelines of ICH Q6B, USP <1032>, <1033> and <1034>.

Custom Biologics maintains a controlled storage facility that can accommodate sample and reagent storage at 2-8°C, -40°C, -80°C, and under liquid nitrogen conditions.

Custom Biologics is a regulatory compliant testing facility with a Quality System based of FDA Guidelines 21 CFR Parts 11, 58 and 211.

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Our Services (40)


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ADCC and CDC Assays

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NAb Assays

Neutralizing Antibody Assays
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Human Biobanking

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Chemical Stability Testing

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ELISA

Enzyme-linked immunosorbent assay
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Mass Spectrometry

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In vitro PK/PD Studies

In vitro pharmacokinetics/pharmacodynamics
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Protein Digestion

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Polyacrylamide Gel Electrophoresis
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Western Blot

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qPCR

Quantitative PCR
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Biochemistry & Molecular Biology

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Project Management

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DNA Services

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Electrophoresis

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Protein Characterization

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Spectroscopy

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PCR

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Biospecimen Management and Storage

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Cytometry

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Cells and Tissues

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Cell-Based Assays

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Immune Cell Assays

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Pharmacology & Toxicology

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Protein Quantification

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Cytotoxicity Assays

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Separation/Purification Services

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Nucleic Acid Services

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Assay Development

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Protein Services

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Biospecimens

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Functional & Cell Type Specific Assays

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Chemistry and Materials

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Gel Electrophoresis

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Protein Expression Visualization

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Biology

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Imaging & Spectroscopy

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Toxicology

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Analytical Chemistry Services

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Dan Mamelak

Director

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