Advanced Modalities: mRNA, Cell and Gene Therapy Manufacturing Services

AmplifyBio redefines the CDMO partnership experience for advanced therapy manufacturing. Specializing in cell therapy, gene therapy, mRNA, and plasmid DNA, we provide tailored CDMO services across all development stages and scales. From concept to commercialization, AmplifyBio seamlessly integrates R&D with chemistry, manufacturing, and controls (CMC), delivering scalable and cost-effective solutions.

Why Choose AmplifyBio as Your CDMO Partner?

AmplifyBio offers a transformative CDMO experience focusing on characterization to ensure product integrity. With our expertise, you’ll benefit from:

  • Comprehensive CDMO Services: Full-scale solutions for process development, tech transfer, process development, analytic development, and GMP manufacturing.
  • Scalability Focus: A clear path from discovery to large-scale manufacturing, minimizing disruptions and maximizing efficiency.
  • Traditional, Hoteling, or Hybrid Models: Flexible options, including full-service CDMO support, full client occupancy, and hybrid approaches for seamless integration.
  • Quality and Compliance: Rigorous standards for advanced therapies, ensuring regulatory compliance at every step.

 

Purpose-Built Facilities for Advanced Therapy Manufacturing

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. 

AMEC
New Albany, Ohio

Choose the Staffing Model that Fits

Hoteling Model

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.

Hybrid SME+ Model

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. 

Full-Service Partner Model

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. 

Integrated Capabilities

AmplifyBio’s combined capabilities span from discovery and development support, including in vivo and in vitro characterization and safety assessments, and an expert team willing to customize the journey to ensure that clients find a development “sandbox” to bring advanced modalities from concept to commercial.  Whatever the modality being developed or the technology platforms implemented, AmplifyBio is here to accelerate the journey to the clinic. 

Additional Preclinical CRO and CDMO Services

ADOC:
Outsourced R&D Services

AmplifyBio Discovery, Optimization, and Characterization

An outsourced R&D solution for benchmarking next-generation therapeutics

ASET:
Preclinical CRO

AmplifyBio in vivo Safety, Efficacy and Toxicology

A preclinical CRO built for the future on a decades-long foundation of expertise and experience

AMEC:
CDMO and CRO

AmplifyBio Manufacturing Enablement Center

A manufacturing partnership for multiple modalities, offered in flexible contract staffing models to fit varied requirements

Partner with AmplifyBio for CDMO Services

Choose AmplifyBio as your trusted CDMO partner to bring your cell and gene therapies, mRNA, and plasmid DNA manufacturing to the next level. With our expertise, innovative facilities, and comprehensive CDMO services, we ensure your therapy development journey is efficient, scalable, and successful.