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Unlock the full potential of your cell and gene therapy development with AmplifyBio’s cutting-edge hybrid manufacturing approach. We offer a range of services, including full-service CDMO support, flexible hotelling options, and a hybrid approach, ensuring seamless tech transfer and GMP manufacturing tailored to your needs.
Our experienced team collaborates closely with you, focusing on optimizing processes, reducing time to market, and maintaining the highest standards of quality and compliance. Whether you’re in early-phase development or preparing for commercialization, AmplifyBio is your trusted partner for success, with the flexibility and expertise you need to succeed.
Advanced therapies experience 400% more chemistry, manufacturing, and control (CMC) related developmental disruptions when compared to other large molecule biologics such as mAbs. AmplifyBio is addressing that challenge by building manufacturing centers where robust characterization is integrated into a manufacturing strategy, ensuring that not only is process development critical but that also, the PRODUCT is the PRODUCT.
What do we mean by that? Process and analytic development is critical when manufacturing cell and gene therapies, but at AmplifyBio you will also identify the product characteristics that ensure the product at discovery, is the same one being scaled up.
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.
