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Work closely with BioPharmaSpec biosimilar experts to plan your biosimilar testing strategies, including full structural characterization and comparability of the originator/ reference product and your biosimilar.
BioPharmaSpec scientists can provide you with quality structural, biophysical and physicochemical analytical data to accelerate the development of your biopharmaceutical.
BioPharmaSpec will develop a MS based HCP method for your product, to quantitate HCP levels throughout your process and in your final product.
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Our scientists pioneered the now well-accepted strategies of mass spectrometric peptide mapping, disulfide bridge assignment and characterization of important glycosylation.
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BioPharmaSpec Glossary
- a-ion
- AAV (Adeno Associated Viruses)
- Accurate mass
- Acetylation
- Acylation
- Alkylation
- Alpha helix
- Amino acids
- Analytical Quality by Design (AQbD)
- ANDA
- Antibody Drug Conjugate (ADC)
- API
- Atomic Mass Unit (amu)
- Average mass
- c-ion
- C-terminal sequencing
- Carbonylation
- Charge variant
- Chromatography
- Coefficient of Variation (CV)
- Comparability
- Dalton (Da)
- Data Dependent Acquisition
- De-novo sequencing
- Deamidation
- Deoxyribonucleic acid (DNA)
- DIA
- Disulfide bridges
- DNA Replication
- Downstream Processing (DSP)
- Drug Product (DP)
- Drug Substance (DS)
- Drug-to-Antibody Ratio (DAR)
- Gamma Carboxylation
- Gene
- Gene (DNA) sequencing
- Gene Expression
- Gene Therapy
- Genetic engineering
- Genome
- Genomics
- Glucocerebrosidase
- Glycation
- Glycoengineering
- Glycosidase
- Glycosylation
- Glycosyltransferase
- Golgi apparatus
- Peptide
- Peptide mapping
- Phosphorylation
- Plant Molecular Farming (PMF)
- PNGase A
- PNGase F
- Polyethylene glycol (PEG)
- Post Translational Modification (PTM)
- Process Related Impurities
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