MedScope is a rapid development organization, and in most instances can initiate value-based discussions within 24 hours. Please contact us at 802-236-8650 or info@medscope.com.

WHAT MAKES A GOOD POTENCY ASSAY?
• Reflects mode of action (MOA)
• Reproducible
• Accurate
• Robust
• Stability indicating
• Practical

CELL AND GENE THERAPY PRODUCTS:
Challenges for Potency Assays
• Complex, variable products
• Mode of action may not be fully known
• Time constraints for release testing
• Limited material available to test
• Limited availability of reference standards and
control


How To Reach Us
MedScope is a rapid development organization, and in most instances can initiate and address a wide range of value-based discussions within 24 hours. Our teams and wide technological network in the biopharmaceutical industry enables us to quickly bring substantial knowledge and problem solving skills to help you quickly solve problems. For rapid response, please contact us at 802-236-8650 or info@medscope.com. 





    MedScope - BioProcess Consultants
        QbD/CMC/cGMP Consultants in Gene Therapy, Immunotherapy, Small Molecule, LentiVector Development: Inception to Launch
         802-236-8650   info@medscope.com

 Commercial Operations

 - LentiVector Development 
 - Commercial Scale Up
 - Cell Line Development/
- Cell Line Mnftr
 - Continuous Manufacturing
 - Process Analytics (PAT)
 - DOE, Multivariate Design
 - Scale-Up,-Out,-Down
 - Development Protocols
 - Equipment
 - Single Use
- Strategic De-risk

Regulatory Science
 - CMC Development
 - Comparability Studies
 - Device Design Controls

Analytical Development
 - Bioanalytic Assays
 - Immuno/PK
 - Product/Impurity
 - Single Use
 - Extractables/Leachables

Medical
 - CMO/Med Affairs
 - Preclinical Development
 - Clinical Development
 - CMC Development
 - Commercial Manufacture
- Strategic Planning
 - Rare Disease
 - Pediatric 
 - Breakthrough Therapies

Manufacturing and ComOps
 - Capital Equipment
 - BSL-2, ISO7
 - Closed Manufacturing
 - Suppliers
 -Tech Transfer

Facilities & Locations
 - 100,00ft2 Manftr/Lab Space
 - 50,000 ft2 Office Space 
 - Cambridge, MA
 - Burlington, VT

Quality
 - Documentation
 - WIFI Controls 
 - QBD, SOP
 - WIFI, BPR, Protocols, 
 - Audits, PAI, 

Sales & Marketing
 - Global Strategic Pricing
 - General Management
 - Strategic Planning
 - Market Planning
 -Alliance Management

Political Advocacy, Gene Therapy
 - Gene Therapy Cost Models
 - FDA Realignement
 - Workforce Expansion
 - Workforce Development
 - Regs Patient Bedside Mnftr

U.S. Defense
 - Biologics Rapid  Monitor
 - Biolgogics Rapid Detect
 - Biologics Rapid Response
 - DARPA, SBIR

Computation
 - Protein/DNA Modelling
 - Process Capability
 - Remote RT View OPC/OLE










802-236-8650, info@medscope.com