Cell Therapy

Cell therapy is the use of living cells to treat patients. Treatments are either autologous CT (treating a patient with their own cells after processing), or allogeneic CT (treating a patient with donor cells after processing, allowing process scaling and the potential for off-the-shelf treatments). Both approaches have their challenges for collection of living cells, growth and delivery to patients, often with constrained supply conditions and timing. Brammer Bio has fully segregated suites and experienced scientific teams to meet your needs for these products.

Ex Vivo Gene Therapy

Gene therapy and cell therapy are overlapping fields of research with the goal of repairing the direct cause of genetic diseases in the DNA or cellular population. Ex vivo gene therapy utilizes a patient’s own cells, which are grown in a clinical suite and modified using viral vectors and other techniques. Around two thirds of gene therapies in development are targeting cancers, with others being focused on diseases believed to result from single gene defects. Brammer Bio has fully segregated suites and experienced teams to meet your needs for these products.

Viral Vector Manufacturing

Viruses represent highly evolved natural vectors for the transfer of genetic information into cells. Brammer Bio’s business model incorporates long-term support using cGMP manufacturing processes that meet your needs for a variety of viral vectors, including AAV, adenovirus, lentivirus, and custom vectors.

Our standards are high. From initial inquiry, through manufacturing, testing and product release, quality is paramount. Our in-house quality and validation teams provide a full range of assay development, analytical services, facility and systems monitoring, product review and regulatory support.

Our flexible approach gives you options. The design of our multi-product facility and use of single use product flow paths allows maximum flexibility for project scheduling while ensuring product quality. We strive to exceed expectations. Our collaborative approach ensures that our client is a partner and well informed throughout the project. Our team is flexible and experienced.

Services offered at our Florida facility –

+ Non-Clinical Production and Process Development
+ cGMP Master and Working Cell Bank Production
+ cGMP Bulk Substance Production & Purification
+ cGMP Vector and Vaccine Production
+  cGMP Cell Therapy Services
+ Sterile Fill and Finish
+ Quality Control Services
+ Quality Assurance Services