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Cell Therapy Development and Manufacturing Services

Cell therapies hold immense promise for patients, but complex challenges can hinder their journey from the lab to the clinic. AmplifyBio understands the unique needs of every cell therapy project, which is why we offer a fully customized approach to help you overcome obstacles and achieve commercial success.

From Concept to Commercialization

Cell therapies hold immense promise for patients, but complex challenges can hinder their journey from the lab to the clinic. AmplifyBio understands the unique needs of every cell therapy project, which is why we offer a fully customized approach to help you overcome obstacles and achieve commercial success. AmplifyBio staff has extensive experience in all aspects of the CMC lifecycle, including cGMP manufacturing, process development, technology transfer, strategic sourcing, analytical method development, qualification, and validation.

Preclinical Toxicology Studies and Services

AmplifyBio is investing in innovative methodologies to drive process efficiencies at scale, accelerate your therapies to a commercial-ready state, and maintain the highest level of compliance.

  • Methodical approach for process development, optimization, and selection of in-process controls (IPCs)
    • Expertise in closing and automating processes
  • Phase-appropriate, product-specific (custom), and platform-based assay development services
  • Bioanalytical method qualification and/or validation services, including potency assay development and qualification
  • Development of analytical methods
  • Process and product characterization services

Clear alignment with your objectives is important for successful tech transfer. Our teams work closely with you to understand your project’s goals, processes, and products. 

  • Systematic approach for introducing new products to AmplifyBio’s GMP systems and facility in New Albany, Ohio (AMEC)
  • Facilitate an efficient onboarding process, ensuring compliance, quality, and operational efficiency
  • Clear line of sight from process development through cGMP

AmplifyBio will manufacture your drug substance and product with strict controls and real-time monitoring to ensure excellence at every step while maintaining the highest level of quality. 

  • Equipped and qualified Grade B and C cleanrooms dedicated to single-client product manufacturing for advanced therapies
  • Powered by a modern technology stack featuring Manufacturing Execution System (MES) for complete traceability
  • Trained and qualified Manufacturing team ready to lead or augment your manufacturing needs

Experience in Multiple Modalities

Cell and gene therapies encompass a diverse landscape of modalities. AmplifyBio stays at the forefront by continuously investing in and expanding our expertise across this spectrum. This includes emerging new modalities, ensuring we have the knowledge and capabilities to support your specific therapy needs. 

We offer extensive manufacturing services for a wide range of modalities, including: 

Autologous and Allogenic Cell Therapies

  • Induced pluripotent stem cells (iPSC)
  • T-cells and Natural killer (NK) cells
  • Mesenchymal stem cells (MSC)
  • Exosomes and other extracellular vesicles (EVs)

  • Hematopoietic stem cells (CD34+ stem cells)
  • Tumor Infiltrating Lymphocyte (TIL)
  • Hematopoietic Stem Cell (HSCs)
  • Regulatory T (T-reg)

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Amplify 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



AmplifyBio Preclinical CRO Services

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Preclinical CRO services play a crucial role in drug development by conducting studies and experiments on potential therapeutics before they advance to clinical trials. AmplifyBio offers a wide-range of preclinical CRO services including:

AmplifyBio Additional Services

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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.