Case Studies

The Hospital for Sick Children- Glycan Analysis of a Multivalent Protein

BioPharmaSpec performed various glycan analysis on a multivalent protein comprised of 24 identical protomers, where each protomer is a 50kDa protein with two sites of N-linked glycosylation.

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HCW Biologics- Characterization of a Fusion Protein Complex

Although always important to consider, applying orthogonal approaches to the characterization techniques was especially important in the case of assessing this unique fusion protein.

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European Biosimilar Company – Structural And Physicochemical Characterization And Comparability

Our client is developing a biosimilar to Simponi and required studies including determination of the primary sequence of an EU RMP Golimumab sample and a structural and physicochemical comparability assessment of three EU RMP Golimumab samples.

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Sekisui – Method Development for a Process Related Residual

An on-line LC/ES-MS method for pDADMAC analysis was developed. Initial mass spectrometric investigations identified key ions shown to be suitable for a quantitative analysis of pDADMAC through a Multiple Reaction Monitoring approach.

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Porton Biopharma- Protein ID and Relative Quantitation

BioPharmaSpec developed and optimized a mass-spectrometry based method to identify and quantify the amounts of proteins present in a wide range of protein formulations, whilst minimizing handling of the product.

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Intas Pharmaceuticals Ltd.- Structural Characterization of PEG-GCSF Using Nuclear Magnetic Resonance (NMR)

ICH Topic Q6B includes the use of NMR as a tool for understanding higher order structure. Here, BioPharmaSpec characterizes several samples of PEG-GCSF using 1-Dimensional (1D) 1H-NMR and 2-Dimensional (2D) 1H/13C-NMR at 800MHz.

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Intas Pharmaceuticals Ltd.- Determining the Extinction Coefficient of PEG-GCSF

BioPharmaSpec determines the extinction coefficient of an Intas PEG-GCSF product. This is an important step to understanding the appropriate dosage and concentration of your product

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ScinoPharm Taiwan Ltd. – Disulfide Bridge Analysis of Linaclotide

ScinoPharm Taiwan Ltd. required a structural assessment of the disulfide bridges in various Linaclotide samples, a challenging project which starts with fragmenting a tightly bound structure.

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Dendritech – Molecular Weight Analysis of Dendrimer Products

BioPharmaSpec performed MALDI-TOF analysis of challenging, high molecular weight dendrimer samples to support Dendritech's developmental and quality related decisions.

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Indian Biosimilar Company- Biosimilar Comparability Study

Our client required structural and physicochemical comparability data for a number of innovator and biosimilar molecules in order to provide comparability data for key quality attributes and demonstrate biocomparability.

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Indian Biosimilar Company- Clone Selection for a Biosimilar Monoclonal Antibody

BioPharmaSpec performed a select number of analyses to determine key quality attributes for a number of biosimilar cell clones. The data from this study was used to select promising biosimilar molecules for further development.

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F-star- Molecular Weight Analysis of Bispecific Antibody Products

BioPharmaSpec analyzed numerous F-star bispecific antibody samples using on-line Liquid Chromatography with Electrospray-Mass Spectrometric detection in order to provide accurate molecular weight data.

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Iksuda Therapeutics – Assessment of Drug Antibody Ratios (DARs)

Iksuda requested an assessment of DARs for their antibody-drug-conjugate (ADC) product in plasma samples derived from mouse Pharmacokinetic (PK) studies.

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Iksuda Therapeutics – Oligosaccharide Profiling of an ADC

Iksuda required glycosylation analysis for their Antibody Drug Conjugate product to provide functionally important post-translational modification information and to ensure that the chemistry used to attach the drug did not impact glycosylation.

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MedImmune – N-Terminal Sequencing

BioPharmaSpec performed N-terminal sequencing analysis of bands observed on SDS-PAGE gels from various protein samples, in order to provide truncation site data that could be used in the planning of potential product improvements.

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F-star – Peptide Mapping of Bispecific Antibodies

BioPharmaSpec performed on-line Liquid Chromatography with Electrospray-Mass Spectrometric detection (LC/ES-MS, Q-TOF)) of proteolytic digests of F-star bispecific antibody samples to provide informative peptide maps.

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