Contract testing and manufacturing services to
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Analytical Services are a key component of testing of biotechnology products to verify safety, stability, and efficacy in the final product formulation. One key component of analytical services is contaminant analysis (or contamination analysis).

BioReliance uses state-of-the-art techniques for the detection of contaminant and bioprocess byproducts such as:

• Microbiological Contaminants
• Host Cell Proteins
• Cell Culture Reagents and Supplements (Insulin, Bovine Serum Albumin)
• Raw Materials from Downstream Processing (Protein A)

BioReliance have performed thousands of contaminant analysis tests for clients in Biopharma. We can provide a fast turn around time and the highest quality testing to produce therapeutics that is contaminant free and safe for use in humans. 

Contact us to find out how BioReliance scientists can help you with your analytical needs. 

Assays are used for bioburden contamination analysis

The isolation and quantitative identification of microbiological and cell-based contamination requires expertise and advanced laboratory facilities. BioReliance offers a wide range of assays for analysis of particulate, microbial, and cell-based bioprocess contamination.

Contamination analysis assays we perform:

• Total Bacterial Count
• Bioburden Analysis
• Microscopic Analysis (Optical, SEM, X-ray Emission)
• ELISA-based Quantitative Analysis

The identification of bioprocess contamination is of increasing regulatory interest; therefore contaminant analysis is a key component of bringing a biological product to market. If you don’t see the assay you are looking for please Contact us to speak with one our expert CRO technicians.

Protein Characterization Assays for contaminants

There are a variety of different analytical methods that can be used to analyze chemical entities and biologics.   For a typical biologic (protein), contaminant detection tests can include the following:

For identity:

• Amino Acid Analysis
• Protein Sequencing
• Peptide Mapping
• Monosaccharide Analysis
• Oligosaccharide Mapping
• Molecular Weight Analysis
• N-terminal sequencing with LC/MS/MS
• Extinction Coefficient Determination

For purity:

• SDS-PAGE Analysis
• RP-HPLC
• SEC-HPLC (Aggregation)
• IEX-HPLC
• Western Blot Analysis
• Host Cell DNA
• Absence of Microbial/Viral Contaminants
• LAL Test
• Immunodiffusion
• Colorimetric Assays

For potency:

• Biological Activity Assay
• In Vivo Assay
• In Vitro Assay