Brammer Bio is focused on providing development and manufacturing of cell and gene therapies through a range of platform technologies.
We offer a wide range of biopharmaceutical development, manufacturing and testing services to the pharmaceutical and biotechnology industry.
Our services include pre-clinical process development, clinical process optimization, process scale-up, process and analytical qualification, and commercial supply. We also provide logistics and warehousing support for in-bound and out-bound biomaterials.
Brammer’s facilities are designed to be fully compliant for cell therapy products and viral vector products under the FDA Code of Federal Regulations (Part 21) and the European Advanced Therapy Medicinal Products’ regulations (ATMPs).
Our GMP facility located in Lexington, Massachusetts will include large-scale, commercial-ready, viral vector manufacturing and fully segregated Grade B clean rooms for cell and gene therapy manufacturing. The 50,000 sq ft facility is dedicated to late stage development, including Phase III and commercial production of viral vector advanced gene therapies. The facility will be fully operational by Q2 of 2017.
Our Alachua, Florida facility occupies a state-of-the-art multi-product validated biopharmaceutical manufacturing facility. Our cGMP Facility includes upstream cell culture modules, a downstream processing module, a cell therapy module, and a fill-finish module. The facility also houses intermediate storage, large formulation/buffer preparation, and labeling and packaging areas.
The fully-equipped Process Development Facility houses separate, client specific project rooms and offers state of the art equipment including multiple bio-reactors, incubators, centrifuges and cold storage. Both the GMP and Process Development Facilities are appointed with Quality Control laboratories to perform multiple stages of testing.
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