Shantanu V. Lale, M.Pharm., Ph.D.

Shantanu V. Lale, M.Pharm., Ph.D. Email and Phone Number

Senior Scientist, Formulation Development at BlueRock Therapeutics @ BlueRock Therapeutics
cambridge, massachusetts, united states
Shantanu V. Lale, M.Pharm., Ph.D.'s Location
Toronto, Ontario, Canada, Canada
Shantanu V. Lale, M.Pharm., Ph.D.'s Contact Details

Shantanu V. Lale, M.Pharm., Ph.D. work email

Shantanu V. Lale, M.Pharm., Ph.D. personal email

n/a
About Shantanu V. Lale, M.Pharm., Ph.D.

• Pharmaceutical research scientist with Ph.D. in Biomedical Engineering (Smart nano-bioconjugates for drug delivery) and 15+ years of research experience in formulation development, drug delivery & biomedical devices• Well versed in experimental study design, formulation development, pre-formulation studies, process development and optimization, stability studies, various analytical instruments and techniques, processing equipment, in vitro cell culture, in vivo animal studies, polymer synthesis and characterization, bioconjugation techniques, intellectual property rights (IPRs) & drug/device regulatory affairs• Excellent communication, writing & analytical skills with a proven publication track record- 18 (6 first-authored) high impact peer-reviewed international journal publications with 850+ citations as well as 2 Indian patent applications and 2 US patent applications

Shantanu V. Lale, M.Pharm., Ph.D.'s Current Company Details
BlueRock Therapeutics

Bluerock Therapeutics

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Senior Scientist, Formulation Development at BlueRock Therapeutics
cambridge, massachusetts, united states
Website:
bluerocktx.com
Employees:
167
Shantanu V. Lale, M.Pharm., Ph.D. Work Experience Details
  • Bluerock Therapeutics
    Senior Scientist, Formulation Development
    Bluerock Therapeutics Nov 2021 - Present
    Toronto, Ontario, Canada
    • Process owner, Formulation lead and Workstream lead for BlueRock's Parkinson's program (DA02 program) as well as previous microglia-based cell therapy product- BRT-MG01 (for Lysosomal Storage Diseases) o Development of cell delivery solutions for delivery of iPSC derived dopaminergic neuronal cells o Development of cryopreservation formulations for improved cryopreservation efficiency, recovery and yield o Cross-functional coordination with different teams from cell cryopreservation stage till final cell suspension for injection (CSI) stage o Writing and reviewing program strategy documents, risk assessment documents for regulatory submission• Supporting development of BlueRock's other cell therapy products including Bemdaneprocel (BRT-DA01 for Parkinson’s disease) and OpCT-001 (for Inherent Retinal Diseases)
  • Biolytical Laboratories
    Formulation Scientist (R&D)
    Biolytical Laboratories Nov 2017 - Nov 2021
    Richmond, British Columbia
    Projects-• Involved in all aspects of new product development including feasibility, process development, formulation optimization, scale-up, technology transfer & regulatory submissions• Development of new improved protein formulations with higher sensitivity & specificity for rapid clinical diagnosis of infectious diseases including HIV, Syphilis, Hepatitis C and COVID-19• Process improvement for protein formulations for high throughput & cost-effective manufacturing• Formulation optimization of protein formulations to improve their stability & shelf life• Stability studies of the optimized protein formulations as per ICH & FDA guidelines• Validation and optimization of process parameters for new manufacturing equipments/ processes• Scale up: Translation of new formulations from lab-scale to large-scale manufacturing • Investigational studies for occurrence of false positive results and other non-conformity issues
  • Texas Tech University
    Postdoctoral Research Scientist
    Texas Tech University Sep 2015 - Oct 2017
    Lubbock, Texas
    Research Projects-I. Pollen grains-based formulation development for oral delivery of proteins • To achieve successful oral delivery of proteins in the intestine while protecting protein molecules from the acidic pH & enzymes of gastric fluid.• Development of protein stabilization strategies, screening of excipients, optimization of protein & polymer concentrations, purification and characterization of pollen grains, characterization of pollen grain formulation, protein loading and release studies, protein conformational stability studies, statistical analysis• Published findings in International Journal of Pharmaceuticals II. Development of universal Influenza vaccine formulation• Development of smart polymeric bioconjugate (PLGA nanoparticles with M2e peptide (A conserved region of extracellular domain of Influenza A virus matrix protein 2)) with reversible and irreversible chemical linkage • Screening of various bioconjugation linkers/ techniques, polymer synthesis and characterization, characterization of bioconjugates, nanoparticle preparation and optimization, gold nanoparticle preparation and bioconjugation, protein loading and release studies, animal immunization studies, plasma antibody titer determination using ELISA, in vivo vaccine efficacy against Influenza virus (H1N1/09), statistical analysisIII. Electrospinning of elastin-like polypeptides (ELPs) for tissue engineering applications• Development of In-house electrospinning apparatus, process development & optimization, characterization of electrospun nanofibers, approaches for crosslinking of nanofibers IV. Processing of Timothy pollens as a suitable vehicle for oral drug/ protein delivery• Development of purification process for Timothy pollens, optimization of treatment steps, characterization of purified pollens

Shantanu V. Lale, M.Pharm., Ph.D. Skills

Drug Delivery Hplc Drug Discovery Chromatography Pharmaceutical Research Regulatory Affairs Formulation Uv/vis Cell Culture Pharmaceutical Industry Pharmaceutics Formulation Development Pharmaceutical Technology Nanomedicine Functional Biomaterials Vaccines Biomedical Engineering Bioconjugate Chemistry Polymer Chemistry Cell Culture Studies Nanotherapuetics Validation Protein Folding Cancer Therapy

Shantanu V. Lale, M.Pharm., Ph.D. Education Details

Frequently Asked Questions about Shantanu V. Lale, M.Pharm., Ph.D.

What company does Shantanu V. Lale, M.Pharm., Ph.D. work for?

Shantanu V. Lale, M.Pharm., Ph.D. works for Bluerock Therapeutics

What is Shantanu V. Lale, M.Pharm., Ph.D.'s role at the current company?

Shantanu V. Lale, M.Pharm., Ph.D.'s current role is Senior Scientist, Formulation Development at BlueRock Therapeutics.

What is Shantanu V. Lale, M.Pharm., Ph.D.'s email address?

Shantanu V. Lale, M.Pharm., Ph.D.'s email address is sh****@****ttu.edu

What schools did Shantanu V. Lale, M.Pharm., Ph.D. attend?

Shantanu V. Lale, M.Pharm., Ph.D. attended Texas Tech University, Indian Institute Of Technology Delhi, National Institute Of Pharmaceutical Education And Research, Savitribai Phule Pune University.

What skills is Shantanu V. Lale, M.Pharm., Ph.D. known for?

Shantanu V. Lale, M.Pharm., Ph.D. has skills like Drug Delivery, Hplc, Drug Discovery, Chromatography, Pharmaceutical Research, Regulatory Affairs, Formulation, Uv/vis, Cell Culture, Pharmaceutical Industry, Pharmaceutics, Formulation Development.

Who are Shantanu V. Lale, M.Pharm., Ph.D.'s colleagues?

Shantanu V. Lale, M.Pharm., Ph.D.'s colleagues are Aravind Anbazhagan, Benjamin Burnett, Sara Kalb, Gregory Pollieri, Bryan Gellner, Phd, P.eng., Joyce Zuoqiao Wu, Ph.d, Yogesh Kumar.

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