Definition of Platform Technology
Platform technology in pharmaceuticals refers to a standardized system or methodology that can be used to develop and manufacture multiple products.
This approach leverages common processes, equipment, or formulations to streamline development and production.
Advantages
Efficiency in Development: Reduces time and resources required to develop new products since the underlying technology is already established.
Cost Savings: Shared equipment and processes lower capital expenditures and operational costs.
Regulatory Simplification: Familiarity with the technology can simplify regulatory submissions and approvals.
Scalability: Platforms are often designed with scalability in mind, facilitating easier scale-up from pilot to full-scale production.
Commonly Used Platform Technologies in Pharmacy
1) Biologic Production Systems
Monoclonal Antibodies (mAbs)
Target specific body components using optimized cell lines.
Processes can be adapted for different mAbs with minor modifications.
Recombinant Protein Production
Utilizes bacterial, yeast, or mammalian cell cultures.
Adaptable for producing various therapeutic proteins.
2) Drug Delivery Systems
Liposomal Systems
Encapsulate drugs within lipid bilayers to improve delivery and solubility.
Applicable to a wide range of drugs once designed.
Nano emulsions and Micelles
Enhance drug solubility and absorption.
3) Gene and Cell Therapy Platforms
Viral Vectors
Includes adenoviruses, lentiviruses, and adeno-associated viruses.
Established delivery methods can be loaded with different therapeutic genes.
CAR-T Cell Therapies
Modify patient T-cells to target and attack cancer cells.
4) mRNA Platforms
Utilized in COVID-19 vaccines (e.g., Pfizer-BioNTech, Moderna).
Instructs cells to produce proteins that trigger immune responses.
Adaptable for various diseases.
5) High Throughput Screening (HTS)
Automated systems for rapid testing of thousands of compounds.
Identifies potential drug candidates efficiently.