AmplifyBio, a leading preclinical CRO and R&D outsourcing partner is announcing the opening of a new business unit to further expand their reach into the manufacturing of next-generation therapies that include cell, gene, mRNA, and other advanced modalities.
The new facility is made up of individual, fully customizable manufacturing suites available in multiple contract staffing models.Read Here
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.
Customizable development labs and GMP suites to enable advanced therapy development and manufacturing through a lease of space. We provide a state-of-the-art facility, QMS and QC, and supply chain management. You stay in control of your process and in control of your timelines.
In this model, clients can send their thought leaders on-site to participate in setting up, personnel training, and executing development and manufacturing processes while relying on AmplifyBio’s scientific and support staff to create the perfect team for the task at hand.
In this model, clients work hand–in–hand with AmplifyBio to develop a robust plan and then trust us with all aspects of the development and manufacturing plan. From initial concept to final product, this model allows clients to focus on other critical aspects of their business while leveraging decades of experience.
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.