Cell Therapy
Our services include:
- product characterization
- manufacturing process streamlining
- clinical development plan
- logistical planning and implementation
Cell therapy is an emerging branch of the biotechnology industry that could revolutionize medicine as we know it today. The great curative and business potential of this relatively new industry is increasingly recognized by the medical, industry and business communities. Furthermore, large biopharmaceutical companies, such as Novartis, Celgene, Amgen and many others have begun to appreciate the business opportunity of cell therapies and are developing (either alone or in collaboration with others) cell therapies for cancer, cardiovascular diseases, neurodegenerative disorders and other hitherto incurable diseases.
Cell therapies pose very specific challenges in addition to known difficulties encountered with regular drugs or biologics. These challenges require a comprehensive approach, and therefore specific experience in this field cannot be overestimated:
- Determination of the complex mechanism of action.
- Characterization of the cellular product. Parameters such as potency, identity, purity, dose, etc., need to be defined and translated into practice for the specific product.
- Development of analytical methods to assess safety and efficacy in vitro and in vivo.
- Development of a reliable manufacturing process in a controlled environment for both research and clinical trials purposes.
- Scale-up of the manufacturing process to support demand and improve yield without sacrificing efficacy.
- Optimization of product shipment and improvement of product stability.
- Quality assurance matters requiring specific attention and sometimes a customized approach.