Cell & Gene

Cell and gene therapies are growing in popularity across the pharmaceutical industry because of their potential to treat and even cure devastating diseases like cancer, metabolic, neurological, and genetic diseases – creating an unmet global demand for viral vectors. These live viral vector products are an essential component in new approaches to manufacturing therapeutics and vaccines, which has established a growing need for CDMO companies with the relevant technologies and expertise to be able to fill the void and meet industry demand. At IDT Biologika, we provide all the necessary activities for new product manufacturing. Our workflow is aligned between each department, which allows us to offer fast timelines and reduced costs.

Our AAV and LVV platforms are applicable for all standard AAV serotypes and LVV variants. Furthermore our AAV and LV platform processes are scalable, cGMP-ready and may accelerate the process development timeline.

Learn more about our overall Service Portfolio for Adeno-Associated Viruses and Lentiviruses.

IDT Biologika’s century-long track record in vaccines and biologics manufacturing and our particular expertise with live agents makes it a natural step for us to employ our process development and drug substance manufacturing know-how to serve the pharmaceutical companies seeking to develop cell and gene therapeutics.

We have experience in a range of technologies used in upstream and downstream processes, which is an advantage to clients as this new segment of the market is still maturing in terms of preferred methods and approaches. Our proven expertise and knowledge developing processes for live agents makes us an ideal viral vector CDMO partner.

IDT Biologika has extensive experience in the transfer and validation of biological processes. We routinely manage transfers of existing products to one of our facilities with practiced efficiency and minimized risk. Our track record scaling processes from clinical to commercial production under GMP and up to BSL-2 enables us to provide the required volumes of high-quality products at all phases in the product lifecycle.

Our technologies and equipment scaling are flexible, enabling us to accommodate variations in volumes or titers required for cell and gene therapeutics.

Our extensive experience with the common manufacturing platforms used in viral vector manufacturing assures product quality and helps smooth the regulatory approvals process. We offer development of client-specific methods, along with all the necessary services in methods transfer, validation, release testing, and stability studies. We support our clients with regulatory expertise and advice based on our considerable experience and knowledge from similar projects, and we will help you in the preparation of CMC documents and required regulatory filings.

Having produced one of the first commercial cell and gene therapy products approved by the FDA and EMA, we have a proven history that you can trust.

All cell and gene therapy specific Quality Control Testing can be done in-house at IDT Biologika. Our broad Analytical Portfolio for Process and Product Characterization includes among others

• Adventitious viruses testing via NGS
• Method for hcDNA is developed and prevalidated in-house
• Mycoplasma method based on qPCR is completely developed, validated and operated in-house
• High experience in Endotoxin testing including low endotoxin recovery (LER) and primary packaging material
• Genome titer is determined with dPCR
• Viral proteins could be profoundly characterized by different MS technologies
• Comprehensive activity testing possible, due to long-term experiences in cell culture and potency assays