Vishal Toprani

Leading development of high-concentration biologic formulations and combination product presentations to support late-stage clinical programs.

Served as Drug Product Lead, leading a multidisciplinary team of scientists and engineers in the formulation, process development, and overall CMC strategy for Penbraya™ — Pfizer's first meningococcal combination PFS vaccine — successfully driving development through BLA, MAA, and ROW approvals and commercial launch. Extensively collaborate with process, analytical, and manufacturing teams to support process development, clinical drug product manufacturing, process qualification, design verification, risk assessments, and process validation for PFS and combination products in compliance with regulatory standards. Authored and managed the preparation of regulatory submissions and queries, including Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), Biologics License Application (BLA), Marketing Authorization Application (MAA), Therapeutic Goods Administration (TGA), Notified Body Opinion, and Canada New Drug Submission (NDS). Led a research and Development initiative in collaboration with Penn State, focusing on the mechanistic understanding of sterile filtration for a multivalent glycoconjugate vaccine. Managed a Technology and Innovation (T&I) initiative in conjunction with the Biomolecule Design group at Pfizer and the University of Leeds, UK. This initiative aimed to assess the utility of an Extensional Flow Device for both developability assessment and formulation development of proteins and monoclonal antibodies, contributing to advancements in biopharmaceutical research. Mentored and coached formulation team members, fostering a culture of excellence, collaboration, and professional development within the department

Led developability assessment and formulation development of biopharmaceuticals Drug product development of high concentration protein modalities including mAbs, bispecifics and fusion proteins Collaboration with Halozyme to develop co-formulation of mAbs Managed formulation related activities with an external CRO/CMO Drug product manufacturing including filter compatibility, TOR and freeze thaw studies In-use IV and SC drug product admixture clinical compatibility studies Authored technical reports for development and support regulatory submissions Supported technical transfer and validation activities Directly mentored research associates and student interns

Dissertation Title: Towards A Better Understanding of Vaccine Stability as Applied to Pharmaceutical Development of Various Recombinant Protein Vaccine Candidates. My research work was focused on extensive analytical characterization to monitor the structural aspects of recombinant protein vaccines and understanding interrelationship of their physicochemical properties with critical biological attributes to develop stable vaccine formulations.

Developed analytical hydrophobic interaction chromatography (HIC) method to detect and quantify oxidation products of mAbs and bispecific antibodies on both forced degradation conditions and storage stability. Designed experiments to study the interaction of oxidized mAbs with FcRn using Octet system.

Performed in-process, product and stability testing using HPLC, Dissolution, UV/VIS, and other related analytical techniques. Analytical Method Development and Validation Moisture content determination in API, USP Standards and product samples by Karl Fisher. Analyzing impurities in API and finished dosage forms. Performed Assay, drug load, delivered dose, particle size analysis, dissolution testing using USP-2 apparatus appropriate to the stage of the project to support R&D efforts. Learned and executed the mechanical calibration , PVT test for USP-1 and USP-2 dissolution apparatus GLP and cGMP Lab notebook documentation Assisting in the calibration of instruments such as dissolution apparatus, weigh balances, temperature probes, pH meter. Efficient knowledge on Agilent HPLC Chemstation and Waters Empower software Knowledge on cGMP, ICH/FDA guidelines

Worked on identification of cancer cell membrane proteome for cancer biomarker discovery. Project dealt with the affinity purification of cell surface proteins followed by identification by LC-MS.

Assisted in Bioanalytical Laboratory (R&D) responsibilities as appropriate. Learned to develop and improve novel LC/MS/MS analytical methodologies for the quantitative analysis of anti-HIV and anti-HCV drugs in various biological matrices. Prepared and analyzed plasma and tissue samples by automated extraction and LC/MS/MS in support of early drug discovery research projects.

Assisted in manufacturing of over-encapsulated products in cGMP area used for Clinical trials