Cell Therapy Development & Commercialization
BioTechLogic’s team of experts has deep expertise and experience working on the front lines of cell therapy development.
While much progress has been made within the cell therapy development arena, many challenges remain, including using and managing unconventional raw materials, delivery specificity, control of activity, detection of potential off-target mutations, and their inherent immunogenicity.
Complete Cell Therapy Product Lifecycle Support Services
BioTechLogic has extensive experience with all cell therapy development and commercialization aspects from preclinical to market.
Cell Therapy Development
Globally, several thousand cell therapy candidates are in development, many of them in early phases of development. Progressing these therapies to commercialization is challenged by manual processes, lack of product characterization, reproducibility difficulties, precise control over cell therapy activity, and immunogenicity management.
How BioTechLogic Can Help
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- Cell colony development
- Product characterization
- Analytical method development
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- Critical Quality Attributes understanding
- Cell processing approach decision-making
- Purification processes
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- Reproducibility
- Process development and scale-up
- Regulatory filing support
- CDMO selection
Cell Therapy CMC Services
CMC Strategy
Quality Assurance
Analytical Services
Regulatory Consulting & Submissions Support
Process Development & Validation
Contract Services & Tech Transfer Support
Supply Chain Management
Inspection Readiness
Project Management
Years
Consultants
Clients
projects
Cell Therapy Resources
The Bustling Cell and Gene Therapy CMO Scene
Pharma’s new and exciting era of targeted therapeutics has the potential to be a turning point for modern medicine. The buzz has led to a flurry of investment in the cell and gene therapy space. According to a recent Alliance for Regenerative Medicine report, nearly...
How the Industry’s Pandemic Response Opened the Door to Therapeutic Opportunities
The biopharma industry was certainly not immune to the turbulence brought about by the COVID-19 pandemic. The pandemic disrupted — and in some cases, stopped completely — clinical trials around the globe. In fact, as of January 2021, more than 2,000 clinical trials...
Gene and Cell Therapy Developers Are Getting Creative to Keep Programs on Track During the Pandemic
Jeanette Young, senior consultant for analytical services at BioTechLogic talks with Tonia Becker, Life Sciences Editor, Macon Raine As it became clear that the COVID-19 pandemic would not be a short-lived disruption, gene and cell therapy companies adjusted their...
Lessons and Insights into the Korean Biopharmaceutical Market During the COVID-19 Pandemic
Tonia Becker, Life Sciences Editor, Macon Raine talks with BioTechLogic's Dr. Eileen Choi How is the COVID-19 pandemic affecting the global biopharmaceutical market? To get at least some perspective on this question, there is no better place to turn to than...
Process Validation for Expedited Approval Drugs
WHITE PAPER Process Validation and Regulatory Review in the Age of Expedited Approval Drugs This paper explores those dynamics and offers some revised approach suggestions.Expedited approval drugs have profoundly changed the thinking and approach to Process Validation...
Cell Therapies – Overcoming Challenges Within the Regulatory Framework
WHITE PAPER Cell Therapies Come of Age: Overcoming Challenges Within the Regulatory FrameworkWithin the cell therapy arena, regulators, the medical community and industry alike are often confronted with an unsettling question. What is this, really? Should a given cell...
