Arun Parupudi
Frederick,MD
Summary
Accomplished biopharmaceutical professional with extensive experience in drug product formulation, process development, and analytical CMC strategies throughout early and late-stage development. Expertise spans diverse therapeutic areas, including monoclonal antibodies, fusion proteins, antibody-drug conjugates, therapeutic vaccines, gene therapy, mRNA LNPs, and enzymes. Strong background in combination products like prefilled syringes and autoinjectors. Consistently authored and reviewed CMC regulatory submissions for global filings. Proficient in driving cross-functional collaboration, optimizing processes, and ensuring smooth technology transfer to GMP manufacturing.
Overview
17
17
years of professional experience
Work History
Associate Director
GSK
07.2022 - Current
- Led a group of Scientists (BS/MS/PhD) responsible for drug product process development, technology transfer and continuous manufacturing of mRNA vaccines
- Served as Drug Product Team Leader (DPTL) for 3 vaccine products ranging from pivotal process characterization, qualification, validation through commercial life cycle management using QbD approach
- Developed drug product manufacturing control strategies, led risk assessment (FMEA), tech transfers to CMOs/internal sites and scale up of process to pilot/manufacturing scales
- Authored key regulatory documentation (IND, BLA, MAA) and provided strategic input on stability protocols and specifications
- Experienced in hiring, staff development and building high functioning teams, responsible for various aspects of process platform development, optimization, and deployment
- Build and manage timelines associated with development and manufacturing activities
- Authored guidance documents for defining overage requirements for lyophilized drug products, photostability, drug product mixing, ensuring alignment with regulatory expectations and manufacturing feasibility
- Improved overall team efficiency by streamlining project management processes and implementing new collaboration tools.
- Set aggressive targets for employees to drive company success and strengthen motivation.
Senior Scientist
AstraZeneca
05.2020 - 07.2022
- Developed commercializable liquid and lyophilized formulations for biologics including monoclonal antibodies, ADCs, bispecifics, enzymes, viral vectors and vaccines
- Prepare and review CMC sections of regulatory submissions, including INDs, NDAs and BLAs and response to comments from various regulatory agencies
Early stage development : FTIH through Phase I :
- Biophysical characterization, screening pre-formulation stage candidates and excipients for optimum thermodynamic and colloidal stability of drug product
- Design and direct IND-enabling studies and support filing through DOE studies
- Present and discuss formulation/stability updates in CMC team and senior project team meetings and incorporate TPP-related modifications in development plans to support FIH clinical trials and IND submissions
- Developed high concentration mAb or mAb related liquid formulations to optimize storage stability, hydrodynamic properties (viscosity), compatibility with primary container closure systems
- Developed lyophilized commercial DP presentations for a bispecific, ADC’s and mAbs
- Led research endeavors aimed at understanding and implementing novel technologies, particularly in high concentration formulation development to establish proof of concept for relevant development projects
Late-Stage Development: Phase 2 and 3 clinical trials :
- Quality by Design (QbD) principle-based commercial formulation and drug product development in specialized delivery devices such as pre-filled syringes, and autoinjectors
- Design and direct BLA-enabling stability and process studies
- Provide subject matter expertise to regulatory groups in preparation for meetings with regulatory agencies
- Design and executed IV compatibility, clinical in-use stability studies to recommend clinical and commercial dosing strategy
Associate Scientist II/III, Scientist
AstraZeneca
05.2009 - 04.2020
- Driven analytical development strategies for early and late-stage biologics ensuring integration into commercialization efforts
- Led developability, product characterization and critical quality attribute assessment activities to ensure alignment with regulatory and commercialization goals
- Authored elucidation of structure, comparability, and impurity Biological License Application sections for Imfinizi (durvalamab), Fasenra (benralizumab) and Lumoxiti (moxetumomab pasudotox)
- Authored and reviewed internal reports of bispecifics, antibody drug conjugates, co-formulated antibodies and vaccines (Examples: Particle risk assessment, Higher order structure, analytical comparability, product quality testing report, charge variants, critical quality attributes, forced degradation studies) for IND and BLA submissions
- Led subject matter expert groups in understanding higher order structure of novel modalities (AAV, mRNA and inhaled programs)
- Developed, qualified and validated separation and biophysical methods (SEC, CEX, AEX, RP), light scattering, DSC, ITC, particulate analyses (light obscuration, micro-flow imaging and microscopy), FTIR, fluorescence, charge variant analysis (iCIEF), CE-SDS, for characterizing s mAb and mAb based modalities
- Facilitated tech transfer of methods to QC testing facility, commercial QC groups and to CMO’s
- Supported and expanded the development of novel technologies to enhance the technical capabilities of group towards product characterization and improvement
Associate Scientist II
Biogen Idec
07.2008 - 08.2009
- Compared colloidal and conformational stability of several mAbs with long term stability
- Established second virial coefficient and diffusion interaction parameter to screen formulations for colloidal stability
Research Technologist
St. Jude Children’s Research Hospital
12.2007 - 05.2008
- Developed and qualified methods for quantifying anti-tumor drug Topotecan using RP-HPLC in human plasma, CSF and whole blood
Education
Master of Science - Biophysics
Mississippi State University
Starkville, MS01.2007
Skills
Professional Profile Skills
- 15 years of experience in biopharmaceutical development, commercialization and manufacturing
- Led the roles and responsibility of as a CMC Analytical, Drug Product formulation and process lead in biopharmaceutical Development
- Cross functional collaboration, high concentration formulation development, process development, technical transfer, sterile fill and finish, management of CDMO and CRO, development/qualification/validation of separation methods and extended characterization methods
Accomplishments
- Medimmune 8 Director awards, 2 Gold awards, 1 silver award, 2 copper awards, multiple catalyze awards for problem solving skills, for a mAb timely supporting process development, tox lot productions, developing sizing assays for vaccines and supporting the successful filing and approval of the IND of a vaccine, Significant contribution towards Imfinzi, Tralokinumab BLA filing and Covid vaccine support
- Biogen Idec Best Technology Investment Award- Arun Parupudi and Tia Estey
Publications
- Size-exclusion chromatography as a multi-attribute method for process and product characterization of adeno-associated virus, SHR Mulagapati, Arun Parupudi, Tomasz Witkos, Nick Bond, Xiaoyu Chen, Thomas Linke, Guoling Xi, Albert Ethan Schmelzer, Wei Xu, Molecular therapy methods and clinical development, 2024
- Comparative thermodynamics of the reversible self-association of therapeutic mAbs reveal supporting roles for linked proton and ion-binding reactions, Mandi Hopkins, Arun Parupudi, Jared Bee, David Bain, Pharmaceutical research, 2023
- Electrostatically driven protein-protein interactions: Theoretical predictions of osmotic virial coefficients to aid antibody drug design, Hassan Shaffer, Qun Du, Arun Parupudi, Reza Esfandiary, Chris Roberts, The journal of physical chemistry letters, 2022
- Nanoparticle technologies: Recent state of art and emerging opportunities, Arun Parupudi, Srihari Raju Mulagapati, Anand Subramony, Nanoparticle therapeutics, 2021
- Global multimethod analysis of interaction parameters for reversibly self-associating antibodies at high concentrations, Arun Parupudi, Sumeet Chaturvedi, Reza Esfandiary, Peter Schuck, Scientific Reports, 2021
- Energetic dissection of Mab-specific reversible self-association reveals unique thermodynamic signatures, Mandi Hopkins, Arun Parupudi, Jared Bee, David L Bain, Pharmaceutical research, 2021
- Quantifying higher order structure, reversible self-association and nonideality in monoclonal antibody solutions, Sumit Chaturvedi, Arun Parupudi, Reza Esfandiary, Peter Schuck, Mabs, 2020
- Structural characterization of an Anti-CD22 Immunotoxin Deamidated Variant, Xiaojun Lu, Niluka De Mel, Arun Parupudi, Journal of Pharmaceutical sciences, 2020
- Energetics of Reversible Self-association by therapeutic antibodies: A comparative analysis, Mandi M Hopkins, Jared S bee, Arun Parupudi, David L Bain, Journal of pharmaceutical sciences, 2018
- Monoclonal Antibody based in vitro potency assay as a predictor of antigenic integrity and in vivo immunogenicity of a Respiratory Syncytial Virus Post-F- Protein, Matieyendou Didier Djagbare, Arun Parupudi, Vaccine, 2018
- Biophysical characterization of Influenza virions, Arun Parupudi, Flaviu Gruia, Jared Bee, Journal of Virological Methods, 2017
- Impact of mutations on Higher order structure of Uricase and activity, Flaviu Gruia, Arun Parupudi, Journal of Pharmaceutical Sciences, 2017
- Both RSA and tertiary structure changes underpin viscoelasticity in monoclonal antibody solutions, Prasad Sarangapani, Justin Weaver, Arun Parupudi, Journal of pharmaceutical sciences, 2016
- Mechanism of Reversible Self-Association of a Monoclonal Antibody: Role of Electrostatic and Hydrophobic Interactions, Reza Esfandiary, Arun Parupudi, Jose Casas-Finet, Dhanesh Gadre, Sathish Hasige, Journal of Pharmaceutical Sciences, 2015
- Practical considerations for detection and characterization of sub-micron particles in protein solutions by Nanoparticle Tracking Analysis, Flaviu Gruia, Arun Parupudi, Journal of PDA, 2015
- Effects of salt-induced reversible self-association on the elution behavior of a monoclonal antibody in cation exchange chromatography, Haibin Luo, Nathaniel Macapagal, Kelcy Newell, Adrain Man, Arun Parupudi, Yiming Li, Yuling Li, Journal of Chromatography, 2014
- A systematic multitechnique approach for detection and characterization of reversible self-association during formulation development of therapeutic antibodies, Reza Esfandiary, David B Hayes, Arun Parupudi, Journal of pharmaceutical sciences, 2013
- High-Throughput Self-Interaction Chromatography: Applications in Protein Formulation Prediction, David Johnson, Arun Parupudi, W. William Wilson, Lawrence De Lucas, Pharmaceutical Research, 2008
Patents
- Formulation of Bispecific Antibodies, Suresh Choudhary, Arun Parupudi, US Patent Application no/ WPO US62/044544, 2016
- Formulations of Anti IL-33 antibodies and methods using the same, Sofia Ekziglou, Mo Ahmed, Reza Esfandiary, Arun Parupudi, PCT/EP2021/062310, 2021
Timeline
Associate Director
GSK
07.2022 - Current
Senior Scientist
AstraZeneca
05.2020 - 07.2022
Associate Scientist II/III, Scientist
AstraZeneca
05.2009 - 04.2020
Associate Scientist II
Biogen Idec
07.2008 - 08.2009
Research Technologist
St. Jude Children’s Research Hospital
12.2007 - 05.2008
Master of Science - Biophysics
Mississippi State University