GMP Cell Therapy Manufacturing

Process Development

Translating lab work into the requirements of Good Manufacturing Practice (GMP) for clinical trials is a challenging process.

Our team can assist you in meeting the requirements of GMP through technical processes and education. With our expertise in process development, we ensure that your product meets the highest standards of quality and safety required for clinical trials.

Dedicated senior project leads are allocated to assist with process optimisation, including:

• process scale up
• seeding
• growth curves
• media selection
• controlled rate freezing

Technology Transfer and Engineering Runs

At Q-Gen, we specialise in replicating your product and process exactly, within the constraints of Good Manufacturing Practice (GMP). Our expertise in technology transfer ensures a seamless transition from your laboratory to ours, while maintaining the quality and integrity of your product.

We understand that release assays and development of analytics are crucial steps in any process, and we take great care to ensure that all testing is performed accurately and efficiently. Our facilities and equipment are designed to meet the highest standards of quality and compliance. Our team of experts will work closely with you every step of the way, from initial consultation to final product release through:

• Assay development
• Cold chain logistics
• Process validation
• National and international regulatory compliance
• Material and vendor qualification
• Donor screening and risk management strategies
• Stability studies

Clinical Trial Production

We pride ourselves on our expertise in cell therapies and our service mindset. We offer comprehensive services to assist with clinical trial design, protocol development, and regulatory submissions. Our team of experts has extensive experience in logistics support to ensure that your trial runs smoothly and efficiently.

We understand that clients are constantly seeking innovative solutions to meet the needs of their clinical trial end points and patients. That's why we're committed to providing flexible services that meet the unique needs of our partners. Whether you require customised cell therapy solutions or assistance with clinical trial design and implementation, we're here to support you every step of the way.

Our innovative approach to cell therapies and our expertise in clinical trial design and implementation can help bring new therapies to market faster and more efficiently.

Quality Control Laboratory

Q-Gen offers comprehensive on-site product testing services, including analytical assays for safety, purity, potency, quantity and appearance.

The safety assays include sterility and microbial contamination testing in accordance with various international regulatory pharmacopeias’ and guidelines (BP, USP, Ph Eur.). Endotoxin testing in compliance with BP and USP as well as Mycoplasma detection through a biochemical luminescence assay or quantitative PCR.

For cell product purity, quantitation and phenotyping testing, Q-Gen utilise Flow Cytometry techniques and offers expertise in panel design and optimisation to support your needs. Furthermore, automated cell counting equipment is available for rapid in-process quantitation. We also have extensive experience with cytokine and cell-based killing assays to assess product function and potency.

The quality control team conducts routine environmental monitoring of the cleanrooms to ensure the facility is maintained optimally for manufacturing. Additionally, we provide testing services to assess both the administrative stability of the product and its long-term stability during storage. These comprehensive quality control services help ensure the safety and efficacy of products for all clients.