Cell therapies hold immense promise for patients, but complex challenges can hinder their journey from the lab to the clinic. AmplifyBio understands the unique needs of every cell therapy project, which is why we offer a fully customized approach to help you overcome obstacles and achieve commercial success.
At AmplifyBio, we specialize in accelerating the development and manufacturing of cell therapies, including CAR-T therapies. Our state-of-the-art facilities and experienced team provide comprehensive services, from early-stage development to full-scale manufacturing. We offer advanced capabilities in process development, analytical testing, and regulatory support, ensuring your cell therapy products meet the highest quality standards. Our integrated approach and cutting-edge technologies enable us to deliver innovative solutions, helping you bring life-changing therapies to patients more efficiently. Partner with AmplifyBio for your cell therapy development needs and experience unparalleled expertise and support.
AmplifyBio is investing in innovative methodologies to drive process efficiencies at scale, accelerate your therapies to a commercial-ready state, and maintain the highest level of compliance.
Clear alignment with your objectives is important for successful tech transfer. Our teams work closely with you to understand your project’s goals, processes, and products.
AmplifyBio will manufacture your drug substance and product with strict controls and real-time monitoring to ensure excellence at every step while maintaining the highest level of quality.
Cell and gene therapies encompass a diverse landscape of modalities. AmplifyBio stays at the forefront by continuously investing in and expanding our expertise across this spectrum, including CAR-T therapies. This ensures we have the knowledge and capabilities to support your specific therapy needs.
We offer extensive manufacturing services for a wide range of modalities, including:
Phase 1 of the 350,000-square-foot manufacturing facility includes standalone B- and C-grade suites that can be configured to accommodate any modality and simultaneously produce multiple lots. The Manufacturing Enablement Center manufacturing suites are complemented by quality, process development, and expansive analytics laboratories staffed by experts at AmplifyBio to ensure that clients have access to a development “sandbox” of assay platforms, technologies, and expertise anchored in experienced GMP quality assurance and facility management.
Preclinical CRO services play a crucial role in drug development by conducting studies and experiments on potential therapeutics before they advance to clinical trials. AmplifyBio offers a wide-range of preclinical CRO services including:
Comprehensive service programs for the development of Cell and Gene Therapy (CGT), mRNA, and other advanced therapies from concept to commercial. Offering expertise and support in discovery, characterization, preclinical CRO safety testing, and scalable manufacturing available in an integrated, innovation-rich environment that goes beyond the value proposition offered by traditional CDMO and PDMO contract models.
