Danielle Heyrman Email & Phone Number

Chicago, IL, US

Melrose Park, Illinois, United States

Method development targeting HPLC analysis, protein characterization, and bioassays for biologic generics

Chicago, IL

• Potency determination of release and stability samples for two biosimilars using validated cell methods
• Testing of samples for ELISA, SDS-PAGE, UV-Vis, pH, appearance, cell-based potency assays, routine mammalian cell culture, etc.
• Lead coordinator for forced degradation studies of biosimilar – thermal, oxidation, pH, photooxidation stress
• Reference standard coordinator for QC lab – RS performance trending for potency methods
• Author of protocols, SOPs, deviations, investigations, change controls, and Certificate of analysis
• Liaison for QC to Engineering for equipment maintenance, movement, and IOQ-PQ

Greater Chicago Area

• Participated and defended cell-based potency assay, UV-Vis, ELISA, DSC to FDA during PAI
• Assisted in authoring of analytical sections for BLA
• Potency determination of release and stability samples for two biosimilars using validated cell methods
• Performed receptor binding ELISA and free thiol assay for protein characterization tests
• Instrument and software qualification of Molecular Device plate readers utilizing SoftmaxPro
• Authoring of protocols, test methods, validations, SOP, deviations, investigations, CAPA, and change controls

Greater Chicago Area

• Mammalian cell culture of M-NFS-60 cell lines utilizing aseptic technique – biological safety cabinets
• Potency determination of release and stability samples for two biosimilars
• Cell based bioassay method development per USP guidelines for potency determination of biosimilars
• Protein concentration determination of in process manufacturing and prepared samples
• Differential scanning calorimetry for thermal melting point determination of biosimilars
• Endotoxin level determination of in process manufacturing samples and final product

• Bioassay method development per USP guidelines for anticoagulants – manual methods using 96-well plates along with automated ACL TOP systems
• Validation of developed methods – Precision, Accuracy, Specificity, Linearity, and Range
• Forced and accelerated degradation studies of crude API – effect on final concentrations
• On-site safety officer – EPA and internal audits, OSHA compliance, RCRA and DOT certified for hazardous chemical management and transportation, ability to sign waste manifests, and SDS management
• Usage of SEC-MALS for molecular weight distribution determination of in process reactions
• Endotoxin level determination of in process and final product API

Lemont, IL

• Cloning and purification of solute binding proteins of ABC transporters from Rhodopseudomonas palustris
• Biophysical characterization of proteins by ITC, Biolayer Interferometry (FortéBio Octet), and fluorescence
• Cloning techniques – primer design, PCR, restriction digests of plasmids, ligation independent cloning (LIC), BL21 cell lines, transformation, DNA agarose gels, safe ethidum bromide handling experience
• Cell culture techniques – preparation and streaking of colonies on agar antibiotic plates, 2XYT small scale and large scale cell cultures, IPTG induction
• Determination of expression and solubility levels of cloned targets by reducing SDS-PAGE
• Preparation of cell lysate by chemical, temperature and sonication

• Quality control of in-process reactions and final product by ASTM methods
• Calibration, maintenance, and troubleshooting of SRI gas chromatograph
• Usage of Karl-Fisher and Free-fatty acid automated titrators, flash point determination, and fixed wavelength UV-Vis spectroscopy
• Research projects for in-process improvements
• Responsible for SOP development, laboratory inventory, supplies, and chemical ordering

• Developed micro immunofluorescence assay utilizing intrinsic tryptophan fluorescence
• Performed protein chromatography techniques including ion exchange, affinity, and size exclusion
• Probed protein identity and function by SDS-PAGE, ELISA, and immunofluorescence assays
• DNA analysis per PCR and gel electrophoresis
• Crystallization of small molecules by slow evaporation, liquid diffusion, and vapor diffusion
• Spectroscopic analysis by use of FT-IR, Raman, 1H and 13C NMR techniques

Kalamazoo, Michigan Area

• Analysis of raw materials, in-process reaction samples, and trace analysis by gas chromatography
• GMP work environment – strong documentation skills
• Maintenance, calibration, and troubleshooting of automated dual channel HP gas chromatographs

Master Of Science (M.S.), Biochemistry And Physical Chemistry

Masters thesis: Investigation of the Stereoselectivity of Antibodies Utilizing Tryptophan Fluorescence & the Effect of Deuteration on.

Bachelor Of Science (B.S.), Biochemistry And Molecular Biology And Acs Chemistry

Activities and Societies: President of Chemistry ClubDouble Major. Two 2nd author publications. Hamaker, C.G., Corgliano, D.M..