A 96-batch Trastuzumab case study in high-throughput characterization
Read MoreBioPharmaSpec 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.
Read MoreAlthough always important to consider, applying orthogonal approaches to the characterization techniques was especially important in the case of assessing this unique fusion protein.
Read MoreOur 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.
Read MoreAn 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.
Read MoreBioPharmaSpec 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.
Read MoreICH 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.
Read MoreBioPharmaSpec 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
Read MoreScinoPharm 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.
Read MoreBioPharmaSpec performed MALDI-TOF analysis of challenging, high molecular weight dendrimer samples to support Dendritech's developmental and quality related decisions.
Read MoreOur 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.
Read MoreBioPharmaSpec 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.
Read MoreBioPharmaSpec 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.
Read MoreIksuda requested an assessment of DARs for their antibody-drug-conjugate (ADC) product in plasma samples derived from mouse Pharmacokinetic (PK) studies.
Read MoreIksuda 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.
Read MoreBioPharmaSpec 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.
Read MoreBioPharmaSpec 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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