Louise Wallace Email & Phone Number

Worthing, Gb

Worthing, Gb

Worthing, England, United Kingdom

Manager Protein Chemistry and analytics in R&D and CMC Regulatory

Worthing, England, United Kingdom

Wrexham

As the key analytical protein chemist, I am actively engaged in leading, developing and executing the analytical characterisation strategy of Ipsen's commercial products. Working effectively in cross functional matrix teams with QC and manufacturing, new analytical technologies will be implemented to widen the understanding and knowledge of the manufacturing process.

Wrexham

As analytical characterisation scientist of the neurotoxin structure and function using classical biophysical methods and neurotoxin specific substrates my findings enabled a new broader understanding of Ipsen’s commercial product and manufacturing process, and factors that may affect the product stability. The knowledge gained has enabled critical lifecycle improvement projects to be informed.

Wokingham

Medium scale elucidation and comparative testing of protein, peptide based biopharmaceuticals and related conjugated products by comparison of secondary and tertiary structure.Stability measurements for innovator and biosimilar products assessed using thermal denaturation. Measurements done under different formulation conditions provided by the sponsor/client. Data collection and analysis in a GxP regulated environment.Peer reviewed documentation such as work files, assay worksheets, solution/equipment logbooks etc according to good documentation practices. Report preparation and submission for study director and sponsor. Raised quality documents and records as required.Actively participated in 2016 FDA audit preparation by performing archiving and maintenance of master schedule entries. Provided support at the meetings by rapidly coordinating document requests and delivery to the FDA inspector.Involvement to address FDA observations – (1) a 2014 OOS assessment, and (2) substantial involvement and co-coordinator in driving a CAPA to completion for a FDA observation

South San Francisco, Ca

• As a member of the assay group I investigated the action of human proteases on C3 using the Complement 3 alpha assay. • Characterized percentage active protein purified using fluorgenic enzyme assays. • Characterized mimotope selectivity using fluorgenic peptides.

Redwood City, Ca

• Established the protein characterization team and ensured available resources. Purified proteins on small scale level, for downstream applications, using an AKTA purifier system. Assessed different protein quantitation and validation methods. Recognized with an award for meeting a challenging deadline of the biofuel project. • Developed an enzymatic assay for screening purposes, scouted optimal separation of protein mixture using an Agilent HPLC system, and characterized cellulases using DSC.

Palo Alto, Ca

• Investigated the biochemical and biophysical stability of proteases, amylases and cellulases. • Analyzed the effects of substrates/products/excipients on a protein’s structure.• Provided biophysical support for all protein bioproduct divisions.• Identified the failure mechanism for proteins (e.g., proteases, amylases and cellulases) in the pipeline to become products. Used DSC and unfolding rates to assess the rate of decay of these proteins.• Performed ligand binding studies for proteins in the product pipeline using DSC and enzyme kinetics.• Assessed the low background activity for proteases, amylases and cellulases using enzyme kinetics to establish criteria for product release.• Analyzed proteins and peptides using MS, protein characterization and quantitation.• Served as technical and task leader of the protein characterization group.

Worcester, Ma

• Investigated the stability, folding and unfolding biophysical characterization of three flavodoxin-like proteins using equilibrium and kinetic conditions stopped-flow FL and CD.• Engineered protein(s) to investigate amino acids important for structure and function. • Wrote the grants and received the funding as the group leader of the project.

State College, Pa

• Biophysically characterized the stability and folding pathways of 3 homologues of the dihydrofolate reductases in the absence and presence of methotrexate. Cloned the human homologue of oxidoreductase and developed a storage mechanism for the protein. • Purified homologues using conventional purification methods and used protein engineering to investigate amino acids important for structure and function.• Contributed towards writing grants awarded to the PI for project funding.

Johannesburg, South Africa

• Maintained and managed Protein Structure Function Research Group. Handled day-to-day running of the laboratory as well as performed research (folding and unfolding; equilibrium and kinetic methods, protein engineering, protein purification).

Doctor Of Philosophy - Phd, Biochemistry

Research Project: The folding and assembly of dimeric human glutathione transferase A1-1.

Bachelor Of Science - Bs, Biochemistry