Biopharmaceuticals

biopharmaceuticals

For the last 30 years, over 300 biotherapeutics have been approved by the US Food and Drug Administration (FDA) to treat diseases which had very limited or no treatment available including several types of cancers and autoimmune diseases. Their main advantage over conventional treatments relies in the fact that they can be designed and tailored to target key steps in the biomolecular causes of the diseases.

These substances are obtained from biological sources such as microorganisms or plant and animal cells and are composed of larger and more complex molecules than “small molecule drugs” produced by chemical synthesis.

However, their production processes involving living organisms may cause unwanted structural changes in the active molecules which can affect safety and efficiency of the final drug. Thus, due to the structural complexity and sensitivity of biotherapeutics to their manufacturing conditions, their quality must be strictly monitored not only during drug development stages but also during the entire life of the drug product. In AMSbiopharma a team of experienced scientists has developed a multiple attribute approach based on mass spectrometry techniques that covers all aspects included in ICH guideline Q6B “Test procedures and acceptance criteria for biotechnological/biological products”.

Biosimilars

Antibody-Drug Conjugates

Monoclonal antibody (mAbs)

PEGylated proteins

Heavily glycosylated proteins

Other recombinant proteins

Peptides

Instrumental

AMSbiopharma contract laboratory services offer a range of capabilities to become a reliable biopharmaceutical industry partner. As a business unit part of the AMSlab team, with more than 10 years of experience, we provide the resources, expertise and know-how on Mass Spectrometry technique and many different applications to help you navigate complex bio/pharmaceutical projects. ​

AMSbiopharma offers a full catalogue of analytical services focused on structural characterization for recombinant proteins and monoclonal antibodies, for both biotech industry/manufacturing sites and for investigational biopharmaceutical centers.

Additionally, throughout our workteam for pharma industry, AMSbiopharma offers customers comprehensive studies for small molecules (quantification, indentification and characterization).

Our Analytical Services for biopharmaceuticals

Aggregation

Despite the high quality of current therapeutic biotech products and the resemblance of recombinant human proteins and antibodies to endogenous human proteins, protein immunogenicity remains an important concern

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Charge Isoform-Pattern

AMSbiopharma have developed a new methodology for the charge variants analysis-based n the use of pH gradient elution using volatile, low ionic strength buffers with direct coupling to high-resolution mass spectrometry (HPLC-DAD-TOFMS).

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Host Cell Protein (HCP)

Ion library creation
Qualitative Identification
Label free absolute quantitation
Absolute quantitation against heavy-labeled marker peptides

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LC Pattern

AMS biopharma offers a wide variety of liquid chromatography separation techniques

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Drug to antibody ratio (DAR)

Drug antibody ratio (DAR) is an important parameter of ADC and refers to the average drug to antibody ratio for a given preparation of antibody drug conjugate (ADC).

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Terminal AA Sequencing

AMSbiopharma offers to our clients a novel strategy based on the combination of the following analysis:
Peptide mapping
MS/MS peptide sequencing
Molecular weight analysis

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Aminoacids Analysis

Quantitative amino acid analysis is a very useful tool in the characterization of recombinant proteins and antibodies.

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Extinction Coefficient

Extinction coefficient is a measure of how strongly a substance absorbs light at a given wavelength.

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Disulfide Bridges

The formation of disulfide bridges in proteins is an important post-translational modification that is critical for stabilizing the native structures of proteins.

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Glycosilation

The addition of a carbohydrate moiety to a protein molecule is referred to as protein glycosylation.

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Peptide Mapping

Peptide mapping is the principal technique for confirm a protein primary structure (amino acid) and a key step in the biopharmaceutical’s characterization.

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Identity and Purity

Molecular Weight

One of the challenges in the development of bioterapheutics and a key requirement of ICH Q6B is the determination of the molecular weight.

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Process Related Impurities

As described in ICH Q6B, the process-related impurities are derived from the manufacturing and are necessary to control in all biopharmaceutical products.

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Get Online Consultation

In most cases, the initial consultation will be sufficient. In more complicated cases, a second, follow-up consultation may be necessary. You can contact our center at any time and ask your questions. Our professional support representative will answer your questions with great pleasure.