Symbiosis supports the GMP aseptic viral vector manufacturing complemented with manufacture of critical raw materials, including plasmids for Advanced Therapeutic Medicinal Products (ATMPs).
ATMPs are complex, often requiring multiple considerations across the manufacturing supply chain. Critical raw materials, such as plasmids, must be thoroughly tested, and products such as viral vectors require highly-specialized handling procedures.
Many target markets for ATMPs are for orphan indications, meaning that their small batch sizes can be challenging for larger-scale manufacturers to handle.
At Symbiosis, we specialize in the provision of aseptic fill and finish services for ATMPs, especially viral vector applications. From our BSL-2 facility, we have over a decade of experience in the GMP manufacture of viral gene and oncolytic viral therapies.
Guided by our experts and specialist capabilities, we also help you manufacture the critical raw materials essential to your processes, from plasmids to viruses to other buffers and dilutants.
With a focus on the fast delivery of clinical and small-scale commercial batches, Symbiosis is the partner of choice for many leading ATMP developers just like you.
ATMPs cover a broad range of newly emerging therapies that fall outside the existing boundaries of small molecule or biologic therapies. The common, although not exclusive thread that runs through these therapies is a form of genetic modification.
This genetic modification could be the end goal of the therapy, as in the introduction of a functional gene as is the case for viral gene therapies. Alternatively, drug developers may harness genetic modification as a step in the development process for cellular therapy, as is the case for many allogeneic cell therapies.
Developers face added complexities if their therapies cross between regulatory classifications, as adherence to various different guidance documents may be required. However, regulatory authorities readily consult with developers to ensure that these next-generation therapies can be brought to patients.
Gene-modified cell therapies cover a range of cell therapies where genetic modification has occurred outside of the patient (ex vivo). Modifications may be made to allow the cells to proliferate, reduce antigenicity or alter cellular function. In CAR-T therapy, for example, T-cells are modified, (often with a lentivirus) to produce an engineered receptor on the surface of the T-cell. This chimeric antigen receptor (CAR) can recognize and bind to specific targets such as cancer cells, allowing the T-cell to elicit an immune response.
Viral gene therapies employ a virus’s ability to incorporate genetic material into a host cell to produce an intended effect. This could be the replacement of dysfunctional or absent proteins or the reduction in the expression of proteins that are causing a particular pathology.
Non-viral gene therapies don’t use a viral vector to allow for genetic transfer to the host cell and instead, use alternative mechanisms for transfer. Genetic material can be delivered directly through electroporation or using transport systems such as lipid nanoparticles similar to the mRNA vaccine technology.
Oncolytic viruses are developed to target and kill cancer cells. They employ a replication-competent engineered viral vector, such as herpes simplex, administered to specifically infect cancer cells causing subsequent rupture and release of the virus for reinfection. This rupturing of the cancer cells also triggers the body’s own immune response to fight cancer.
