Process Development Analytical

Matteo Placidi

****.*******@*****.*** 978-***-****

Lexington, MA

Summary

Experienced CMC leader with a track record of success in the development of biotherapeutics from preclinical to PhII. Expertise in the implementation of new analytical technologies and establishment of phase appropriate toolkits for a range of systems from small molecules, antibodies, fusion proteins, ADCs and AAVs.

Drug Development Experience

• Oversight of analytical development and process analytics core testing groups, to support preclinical, process development and IND activities.

• Coordination of CROs, CDMOs and equipment vendors for method development, transfer, and qualification/validation.

• CMC analytical lead for candidates at various stages from pre-clinical to PhII coordinating interdepartmental process development efforts.

• DS/DP GXP release and stability testing to support critical manufacturing campaigns.

• Reference standard qualification and trending.

• Formulation design, forced degradation, solubility, and stability studies.

• Authored CMC sections of IND filings, SOPs, technical reports, training, and safety documents Technical Skills

• Chromatography: IA, SEC, RP, HIC and IEX

• Capillary Electrophoresis: CESDS, CIEF and CGE-DNA

• LCMS/MS analysis: peptide mapping, intact mass, characterization and quantification

• Genome characterization qPCR, ddPCR and Gel analysis

• Aggregation analysis: SEC-MALS, DLS and MFI

• Biophysical characterization: DSC, DSF, and CD

• Glycosylation: monosaccharide, sialic acid characterization and N-linked Glycan analysis

• Synthesis, purification, and formulation of antibody drug conjugates

• Solid state characterization: PXRD, optical microscopy and FTIR

• Spectroscopy: UV/Vis, luminescence, and quantum yield measurements

• NMR: multi-nuclear, inversion recovery, spin echo, NMRD and VT Work Experience

MPP Analytical LLC, Lexington MA, Principal Consultant 12/2024 – Present

• Providing oversight of analytical strategy for biologics and AAV based therapeutics from preclincal development to release of clinical stage material.

• Input for analytical CMC including assay development, tech transfer, CRO/CDMO oversight, GMP qualification and validation, forced degradation, stability studies, advanced characterization, study design, SOP, technical report and authorship of regulatory documents. Voyager Therapeutics, Lexington MA, Consultant 12/2024 – Present Director, Analytical Sciences 07/2023 – 12/2024

Associate Director, Analytical Sciences 03/2021 – 07/2023 Senior Scientist II, Analytical Sciences 02/2020 – 03/2021 Senior Scientist I, Analytical Sciences 07/2018 - 02/2020

• Leading the Analytical Sciences group, implemented several technologies for previously uncharacterized attributes of engineered capsids for production and release of clinical material.

• Led the Drug Product Sciences group on an interim basis performing formulation development, candidate screening through extensive stability and forced degradation studies.

• Devised analytical strategy for preclinical to PhII candidates, activities supporting candidate selection, R2D transition, process development, assay optimization, formulation development, GLP Tox production and stability testing.

• Facilitated the analytical response to a CMC related IND hold, resulting in its removal.

• Oversaw analytical method tech transfer to CROs, including method qualification and document review for GMP release and stability testing.

• Designed, coordinated, and executed two forced degradation studies for two clinical candidates, presenting findings at gene therapy conferences.

Acceleron Pharma, Cambridge, MA, Scientist - Analytical Development 07/2015 – 07/2018

• Developed and optimized a range of analytical assays for a series of fusion proteins from preclinical to PhII (charge, size, purity, sequence, glycosylation, and product variants).

• Acted as analytical lead providing testing support and collaborating with the process development group, focused on improving yields and developing high concentration formulations.

• Assisted formulations group to devise new HTS techniques to determine optimal DP vehicle, with support during detailed stability/forced degradation studies.

• Oversaw multiple external projects to develop/optimize existing assays including extended DS characterization.

• Devised and transferred analytical test methods internally for GMP manufacturing campaigns.

• Served as part of a committee to set phase appropriate release specifications. Wolfe Laboratories, Watertown, MA, Postdoctoral Scientist 08/2013 – 07/2015

• Performed method development to assess the biophysical properties and stability for ADCs during synthesis, purification, and formulation: structure, heterogeneity, surface charge and size for clinically relevant formulations under ambient and stressed conditions.

• Designed and executed experiments for multiple GXP projects coordinating with QC/QA. Developed small molecule therapeutics at various stages: ADME/ PK, physicochemical characterization, analytical method, and formulation development.

• Devised and implemented experimental procedures for the handling of highly potent materials. Established safety protocols as the chemical hygiene and cytotoxicity safety officer.

• Developed and managed programs for the maintenance, operation and troubleshooting of the HPLC, UPLC and LC-MS systems.

Max Planck Institute for Biological Cybernetics, Germany, Postdoctoral Scientist 07/2009 – 07/2012

• Designed, synthesized, and characterized a series of gadolinium complexes for simultaneous application in MR/optical and dual frequency MR imaging (1H and 19F).

• Initiated collaborations at research institutes and laboratories across Europe to examine the biocompatibility of these new agents through potentiometry and cell culture experiments. Education

The University of Manchester, UK, PhD, Analytical Chemistry 09/2005 – 06/2009

• Thesis: Polymetallic lanthanide complexes for application in luminescence and MRI The University of Manchester, UK, MChem, Analytical Chemistry 1st Class

(equiv. BSc + MSc Chemistry, GPA 3.8-4.0) 09/2001 – 07/2005

• Thesis: The distribution of anthropogenic radionuclides along the west coast of Britain Publications, conference presentations and patents: Lists available on request Languages: Intermediate level German and Italian.

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