Brammer Bio provides a complete range of development, and early phase to commercial GMP manufacturing services for gene therapies using multiple platform technologies.
Our services are comprehensive. They include pre-clinical process and analytical development, process optimization, process scale-up, process and analytical qualification, clinical and commercial supply of drug substances and formulated drug products. We also provide logistics and warehousing support for in-bound and out-bound materials.
Our standards are high. From initial inquiry through development, 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 set up and monitoring, product review and
Flexibility is at our core. The design of our multi-product facilities and use of single use equipment allows maximum flexibility for project scheduling while ensuring product quality. We strive to exceed expectations. Our collaborative approach ensures that our clients are engaged and well informed throughout the project.
Compliance is key. Brammer’s facilities are designed to be compliant for viral vector-based gene therapy products under the FDA Code of Federal Regulations (Part 21) and the European Advanced Therapy Medicinal Products’ regulations.
Brammer’s facilities are designed to be fully compliant for viral vector manufacturing under the FDA Code of Federal Regulations (Part 21) and the European Advanced Therapy Medicinal Products’ regulations.
projects executed l first-
in-human trials l over a decade of experience in gene therapy manufacturing
clinical lots AAV, ADV, RV, HSV, LV l T-cells
team members and over 20 years of experience in commercial biologics manufacturing