Process
Development
Optimized Process Development
for Cell & Gene Therapies
Service
Description
At CCS, we specialize in Process Development for cell and gene therapy, helping biotechnology and pharmaceutical companies optimize their cell-based therapies from early development to large-scale production. Our comprehensive approach combines cutting-edge technologies, CMC expertise, and a commitment to quality, ensuring your therapies reach the clinic and market efficiently.
Why
Choose us?
Expertise you can Trust
Scalable & GMP-Compliant
Customized Solutions
Dedicated Development Lab (Houston)
Service
Offerings
Initial Consultation & Feasibility Assessment
We evaluate your therapeutic product’s needs, assess process development strategies, and identify potential risks for optimal manufacturing outcomes.
Process Analytics
We implement robust testing plans for starting material characterization, in-process testing, product characterization, and final product quality control.
Process Development
We design reproducible protocols for cell isolation, expansion, and differentiation, ensuring high-quality product output across various cell types.
Tech Transfer
We ensure a seamless transition from R&D to GMP manufacturing, maintaining quality, yield, and consistency while implementing necessary documentation and protocols.
CMC Consulting Support
Our experts help streamline operations, mitigate risks, and ensure regulatory readiness, from early development to clinical trials and late-stage development.
Process Optimization
We refine protocols, raw materials, and automation to maximize yields, enhance efficiency, and ensure scalable production.
Scale-Up
We facilitate the transition from early-phase production to large-scale manufacturing, ensuring efficiency, cost-effectiveness, and GMP compliance at every stage.