BLA enabling Late Stage Development Oversight and Leadership of Analytical, Formulation and Drug Product Process Development:ARX788 ADC Method Validation, Impurity Peak Characterization and CQA establishment, Formulation Robustness Study; Specification tightening; Extractable and Leachable studies for container closure and manufacturing components; PPQ Batch analysis and Global Comparability Studies; Primary Batch Stability and Two-tier Reference Standard strategy and qualification: DP manufacturing, PC PV and resupply oversight. Global regulatory submissions in 13 countries and effectively responding to health authority Information Requests. ARX517 ADC for Prostate Cancer: Developing Next Gen First and Best in-class Formulation; oversight of Comparability, extended characterization, DP Manufacturing and Stability Program.ARX305 ADC for RCC: IND enabling studies oversight including clinical use compatibility and stability, and IND M3 section authoring leading to safe to proceed clinical trials response from FDA.ARX102 Pegylated IL-2 IND enabling studies and authoring/reviewing IND sections.

Leading analytical and formulation development and Drug Product Manufacturing of 2 ADC clinical development projects--for breast, gastric, and prostate cancer; and 3 IND Development projects (ADC targeting CD70, and Pegylated cytokine and and bispecific Fab); assessment of CQAs, and PTMs for Cell line, Cell Culture, and Downstream Product Development.Heading a Team of 7 and responsible for all Analytical & Formulation Development, and transfer. Set strategy, and oversee method development & qualifications; mAb, ADC drug substance and drug product manufacturing support, release, stability, global comparability studies and regulatory submissions, root-cause analysis and CAPAs. CMC Liaison for coordinating multiple activities with mAb, ADC, and Drug Product Fill/Finish CMOs (Person-in-plant); and clinical-use compatibility studies for 2 clinical stage programs.Led analytical method establishment, qualification, suitability, Reference Standard Qualification; 3 GMP DS batch release of mAb and ADC products; Stability studies with 4 CMOs; and 3 GMP DP manufacturing campaigns (PIP).Technical Expertise: Sequence liability and hot spot assessment for developability and manufacturability; HPLC method development, peptide mapping, LC/MS, CE, icIEF oversight, DLS, DSC, CD, AUC, SEC-MALS, visible and sub-visible particulate matter analysis and particle characterization; liquid and lyophilized formulation development, forced-degradation studies, PTM and impurity characterization. in-process and process residual methods including Titer, Protein A, HCP, polysorbate, residual drug and linker.

Analytical and Formulation functional head, led POC to IND, and Phase 2/3 stage development of novel full-length and Fc-fusion protein of histidyl aminoacyl tRNA synthetase physiocrines (ResolarisTM and ATYR1923), pre-clinical stage anti-AARS mAb and other pipeline.Strategic Planning and Direction of all Analytical, Formulation and Stability studies of novel class ofBiologics involving internal process development activities and external IND enabling pharmaceutical development, and associated CMO functions (DS and DP specifications and lot release, QC data review, fill/finish, Stability, and Comparability). Mentored 5 direct reports, and managed external contracts. Develop SOPs, ADP, Formulation Design and PQ Standards and Acceptance Criteria.Directed CRO activities for formulation development and extensive state-of-art biochemical and biophysical protein characterization. Methods and Technology Transfer and Qualification; PTM characterization and CQA assessment. Designed side-by-side analysis and comparability of drug substance and drug product batches from multiple campaigns, scale and facility changes, and critical review of protocol, data, and Reports.Project Leader for novel formulation enhancement technologies to evaluate alternative delivery routes for patient-friendly administration.Authored CMC section of CTA, pre-IND and IND applications, Type C Briefing Book on Comparability, and responded to CMC questions from FDA and EU regulatory authorities.Methods Expertise: HPLC method development and Qualification; Particulate Characterization including MALS, DLS, AUC, HIAC, Visual, FTIR microscopy; Biophysical Characterization including DSC, DSF, CD, Intrinsic Fluorescence, ELISA-based and enzymatic potency assays; ligand binding assays including SEC and DLS mobility shift, ligand blotting, and ITC.

Strategic and Operational Head of Formulation group. Gap-analysis and evaluation of Technologies to expand and implement new high-throughput tools in the company’s successful Biologics formulation services unit. Provided BD support by designing formulation and clinical configuration compatibility studies for clients, and writing Scope of Work and Proposals. Galvanized and Managed a dedicated group performing high quality and creditable contract service studies on protein pre-formulation, liquid and lyophilized formulation development and optimization, analytical comparability, stability studies including forced-degradation, photostability, and clinical-use compatibility on Mabs, ADC and Biosimilar Drug products of Mabs and Coagulation Factors.

Set-up, and Direction of a fully operational preformulation and drug delivery POC lab with personnel to perform co-formulation development of PH20 and various drugs, and support dose solution preparation and characterization for nonclinical studies. Lead selection of preclinical lead formulation candidates for further development using following animal models: ISR [injection site reaction]; large volume SC infusions of antibodies; intradermal dye dispersion, and testosterone-induced benign prostatic hyperplasia (BPH). CMC Project Lead on Depot Hyaluronidase formulation for local instillation in BPH animal model; authored patent application, documentation, Product Development Report, and presentation of Biologics Drug Delivery Technology Asset for due diligence.Evaluated co-formulation of commercial injectable antibiotics with PH20 hyaluronidase that could enable subcutaneous infusion by outpatient administration instead of iv infusion indicated for infectious diseases. Directed development of a challenging prototype frozen liquid formulation of a conditionally-active autocatalytic protease (Cathepsin-L) for dermatology indications. Screened several preservative combinations with Insulin and PH20 to minimize protein aggregation and preserve activity by DSC and DLS melting experiments, and determined oligomeric state of insulin by AUC, DLS, and non-denaturing SEC-HPLC.

Lead characterization and optimization of solubility, in-use stability and process reaction conditions for site-specific bivalent conjugation of small molecules and peptide pharmacophores with a Universal catalytic mAb carrier platform. Developed robust processes for mAb conjugation of various anticancer and diabetes therapeutics, and transferred process and in-process assays to CMO for scale-up to 350 g.Directed and designed, developed and qualified a host of analytical methods for intermediates release, conjugation in-process assays and product release assays including, stability-indicating assays involving HPLC (SEC, IEX), ITC, DSC, fluorescence and UV-VIS spectroscopy, DLS.Characterized several antibody API, advanced intermediates, and final conjugated mAb products. Lead the preparation, purification, characterization and formulation of all critical reagents for ELISA-based potency, PK and immunogenicity assays.

Project Leadership for formulation development of recombinant idiotypic mAb drug substance and the mAb-KLH conjugate cancer vaccine product for NHL, stability studies; supervision of scientific staff.Hands-on development of particle size and zeta-potential methods as in-process assays and support formulation development and product characterization.API and final mAb-KLH drug product analysis and characterization, and development of release and stability-indicating assays, and specifications.GLP analytical methods development for the characterization of mAb modifications (methionine oxidation, aggregation and fragmentation, deamidation/iso-Asp formation) using HIC, SEC, IsoQuant, IEX, and excipient content analysis by ELSD HPLC detection.

Designed and executed proof of concept, formulation optimization, analytical method development and preclinical IND-enabling PK, and PD studies with controlled-release liposomes.Experimental design and supervision of 5 different-Partnered projects involving sustained-release multivesicular liposome formulation, analytical development, and POC in preclinical animal models for G-CSF, G-CSF chimeras of IL-3 and flt3; leptin, and EPO (alpha and beta forms).