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With an established record for safety, potency, and effectiveness, mRNA-based therapeutics are a fast-growing area of interest for application across many disease areas. AmplifyBio has built for-purpose in vivo and in vitro safety assessment capabilities for mRNA/LNPs and manufacturing suites that can be customized for the early stage through GMP manufacture.
To better meet the needs of this development area, AmplifyBio is partnering with RNAV8 Bio to ensure clients start with well-designed, optimized, stable mRNA.
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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.
