Our Team

Cell Therapy & Biologics,  Technology Transfer, Validation, Technical Investigations, Regulatory Submissions, Strategy

Quality By Design, Product Characterization, Analytical Development, Regulatory Submissions

Cell Therapy, Gene Editing, Vaccines, Viral Vectors, Analytical development, Method Qualification, Method Validation

Characterization/Comparability, Method Lifecycle Management, Regulatory Submissions, QC, Technical Documentation

Project Management, Tech Transfer, Cell Therapy, CAR-T, Lentivirus, Risk Based Approach, Process modeling, technical writing, CMC, Smartsheet

Quality Assurance, Quality Control, Quality Systems, Compliance Audits & regulatory Inspections, Regulatory Requirements

Process & Analytical Development, Technology Transfer, cGMP Manufacturing, Project Management, Cell Culture, Microbial Fermentation, Monoclonal antibodies, ADC’s, mRNA and Lipid Nanoparticles.

Quality Assurance, Quality Control, Quality system, GMP Audits & Inspections, PAI, Regulatory Requirements

GMP Manufacturing, Technical Transfer, Remediation, External Manufacturing, Supplier Relationship, Operational Excellence

Biologics & Viral Products, Expression Systems, Cell Banking, Technology Transfer, Regulatory Submissions

Protein Engineering, Mammalian & E. coli expression, Formulation, Refolding, Downstream Development, Analytical Development, Strategy.

Clinical Development, Pharmacovigilance, Clinical Safety, Medical Affairs, Business Development, Licensing

Biologics, Biologics Process Design, Microbial Process Development, Statistical Data Analysis, Statistical Design Of Experiments

Quality Assurance, Supplier Quality Management, Validation, Change Control, CAPA, Project Management

Formulation Development, Drug Product Development, High Throughput Screening, High concentration/viscosity, Co-formulation, Viral Vectors

Biologics cGMP Manufacturing, Cell and Gene Therapy, Technology Transfer, Investigation, Change Control, Operations
Management

CMC Statistics and Data Analytics, Data Processing Automation, Business Intelligence, Process Characterization, Data Governance

Process Characterization & Validation, Technology Transfer, Lyophilization, Drug Product, Formulation Development, Combination Products

Cell & Gene Therapy, CMC Strategy, Product Development, Regulatory Submissions
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Bioassay & Potency Assay Development, Transfer & Qualification, QC Implementation, Biological Characterization & Comparability, Biosimilarity

Cell Therapy, Product Development, Risk Assessment, Regulatory Submissions, Project Management

Biologics, Formulation, DP Development, Lyophilization, Analytical Development, Comparability, Characterization

Process Design, Process Development, CMC, Biologics, CDMO Selection & Management, Process Characterization

Facility Design, cGMP Programming, Feasibility Layouts, Equipment Space Testing, Containment Design, Facility Gap Analysis

Biologics manufacturing, Process Development, Fermentation, CHO cells, ADC, Fusion proteins, Monoclonal antibodies, CMC regulatory

Process Development, Technology Transfer, CMC Regulatory, CDMO Management, Due Diligence, Facility Fit

Cell and Gene Therapy, CAR-T, Technology Transfer, Process Characterization, Process Control, Life Cycle Management