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mRNA Development, Safety, and Manufacturing

With an established record for safety and efficacy, mRNA-based therapeutics are a fast-growing modality of interest for application across many indications. AmplifyBio is building the capabilities to be a premier partner for developing and commercializing safe, effective, and stable mRNA products that can be manufactured in a scalable and efficient manner. 

An Sandbox for Developing mRNA Drugs

At AmplifyBio, we are building a one-stop mRNA discovery, development, and manufacturing ecosystem that combines in-house capabilities and expert industry partnerships. This enables us to leverage the experience, platforms, and efficiency needed to address the critical considerations required to bring mRNA therapeutics to market. 

  • Delivery efficiency 
  • Immunogenicity and inflammatory responses
  • Stability 
  • Precision and control of translation
  • Scalability and manufacturing
  • Tissue-specific targeting
  • Clinical translation 
  • Safety data for regulatory hurdles
  • Cost and accessibility 

mRNA From Concept to Commercial

AmplifyBio has added mRNA design and optimization expertise to already established discovery, process development, analytical development, in vivo safety, and manufacturing capabilities.  This capability enables clients to optimize their mRNA for features like half-life, translation efficiency, and potentially even tissue specificity.

  • mRNA sequence optimization
  • Rapid generation of multiple designs for a rapid build-test cycle
  • In vitro assay expertise for informed design decisions

AmplifyBio’s Plasmid Platform offers a standardized, efficient, and cost-effective production of plasmids to serve as reliable input material to support mRNA development and manufacturing activities.  

  • Scale-up and manufacturing of existing plasmid constructs for mRNA   
  • Proprietary plasmid backbone designed for rapid cloning and mRNA production

AmplifyBio works closely with partners and clients to customize and optimize lipid nanoparticle (LNP)-based encapsulation of mRNA according to specific therapeutic needs and regulatory requirements. This collaborative approach ensures that the final product meets clinical objectives and patient safety standards while being manufacturable.

  • LNP formulation development
  • LNP functionalization and in vitro testing
  • LNP characterization (e.g., encapsulation efficiency, size)

AmplifyBio can make parallel batches of mRNA research scale (< 2 mg), encapsulate, and test in vitro to enable improved design decisions and scale-up support in preparation for technical transfer to a GMP environment.

  • Includes panel of critical Quality Control assays
  • Material supports both in vitro and in vivo animal studies (non-GLP)
  • Process optimization, verification, and confirmation
  • Expertise in closing and automating processes
  • Development of analytical methods
  • Process and product characterization

Clients can leverage AmplifyBio’s Safety, Efficacy, and Toxicology business unit to conduct in vivo safety studies (GLP and non-GLP) of mRNA-based therapeutics in various animal models, including analytical development and testing for critical endpoints.

  • Toxicology
  • Safety pharmacology
  • Biodistribution
  • Immunogenicity (vaccines)
  • New analytical method development and qualification

The team at AmplifyBio brings decades of experience manufacturing cell and gene therapies for clinical trials and full-scale commercialization. That experience drives us to build a manufacturing system that integrates robust characterization and optimization for better product efficacy, scalability, and safety and, ultimately, a lower cost of goods (COGs).

  • Precision Encapsulation
  • Scalable Production Processes

Manufacturing at AmplifyBio

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Manufacturing Enablement Center (AMEC)

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 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.

  • Qualified, calibrated, and maintained equipment
  • Controlled rate freezing
  • Cryo freezer storage
  • Sample management facility
  • Validated electronic inventory management control
  • Electronic batch record option
  • Cleanroom environment monitoring
  • USP utility monitoring
  • 2000 sq ft outfitted Quality Control Laboratories
  • In-process and release testing
  • Lot characterization capabilities:
    • Bioanalytical methods
    • Molecular biology methods
    • Cell therapy methods

Contact Us

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.