Strengthen Cell & Gene Therapy Production with Smart Quality Testing
Today, cell and gene therapies, along with other cutting-edge scientific approaches, are reshaping how diseases are treated or cured. These innovative treatments offer new hope for patients, but developing them presents many challenges due to a complex manufacturing process.
Overcoming Manufacturing Challenges
The journey from concept to treatment involves navigating several hurdles:
- Low-Production Volume: Limited production capacity can hinder widespread availability.
- Short Product Shelf Life: Ensuring the therapies remain effective over time is crucial.
- Complex Raw Materials: Sourcing and managing high-quality materials is essential.
- Tracking and Data Integrity: Maintaining accurate records throughout the process is vital.
- Scalability: Expanding production to meet demand without compromising quality.
- Patient Demands: Meeting the specific needs and expectations of patients.
Ensuring Safety, Efficacy, and Quality
To ensure the safety, efficacy, and quality of cell or gene therapies administered to patients, comprehensive quality control assays are implemented throughout the manufacturing process. This includes:
- Safety Testing: Critical to protect patient health, focusing on microbial contamination prevention and detection, such as microbial & mycoplasma contamination and endotoxin detection.
- Cellular Quality Attribute Testing: Ensuring the cell’s effectiveness throughout the manufacturing process by assessing viability, phenotype, purity, and potency.
We understand that manufacturing cell and gene therapies requires reliable analytical testing systems to ensure patient safety and validate personalized treatments. At bioMérieux, we offer microbiology solutions that provide rapid results, low volume utilization, automation, ease of use, and data integrity.
Through our partnership with Accellix, we provide comprehensive diagnostics for cellular quality attribute testing. Our automated solutions enable on-site testing throughout the production process, helping us deliver finished products quickly to patients.
