Chemistry, Manufacturing, & Controls (CMC)

CMC Analytical Development Services for Drug Development

CMC bioanalytical testing is required for all drug development programs. These assays are used to monitor the drug manufacturing processes and ensure the safety, efficacy, and quality of pharmaceutical products. CMC bioanalytical strategies are inherently complex and must be individualized for each therapeutic program.

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Analytical testing services for biopharmaceutical product development

BioAgilytix has expertise with a wide array of CMC bioanalytical readouts and across many therapeutic modalities. Our team possesses deep expertise in the CMC field and can provide guidance for designing the appropriate manufacturing support package from purity and sterility testing to potency assays for lot release testing. Our bioanalytical development and testing experts can support your biopharmaceutical product through all phases of drug development. We are committed to finding the most efficient and appropriate path to advance your project.

CMC Bioanalytical services

Assay Types

Potency / strength / content / identity

  • Expressed proteins
  • Expressed GOI
  • Biomarkers and related cellular indicators
  • Activated/deactivated target genes
  • Genome and Viral titer
  • Infection/transfection/transduction efficiency
  • Capsid/viral particle number

Impurity and trace analysis

  • Trace impurities
  • Host cell proteins
  • Residual host DNA
  • Residual insulin, antibiotic, and other process residuals
  • Residual plasmid

Analytical Format

  • Cell-based assays
  • Immunoassays
  • Molecular assays
  • Image analysis
  • Enzyme activity assays
  • Mass spectrometry

Expertise

  • Proliferation
  • Activity assays
  • Panel screens
  • ADCC/CDC
  • Neutralization assays
  • MOA determination
  • Trace analysis
  • Cell culture including master/working banks
  • Protein chemistry
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Advanced platforms for CMC support

The array of assay types required for a full CMC support package require a bioanalytical provider with access to and experience with diverse platforms. At BioAgilytix, we utilize the latest CMC analytical and detection platforms including:

  • Multiplex ELISA (MSD-ECL)
  • Flow Cytometry
  • qPCR/ddPCR
  • LI-COR Odyssey/ChemiDoc
  • ELISA
  • LC/MS
  • HRMS
  • Capillary Electrophoresis (CE)

Global CMC Bioanalytical support

In addition to our full CMC-analytical team at the BioAgilytix headquarters in Durham, North Carolina, our European facility in Hamburg, Germany is GMP-compliant and provides quality control testing for product and batch release of biologicals. With this global presence, BioAgilytix has the flexibility to support our sponsors, no matter where their therapeutics are manufactured.

PRESS RELEASE

Learn more about our European presence

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BioAgilytix’s solutions for CMC Bioanalytical challenges 

Due to the unique considerations for each drug modality and program, there are many challenging aspects of designing and implementing successful manufacturing programs, including the bioanalytical strategy. Common challenges in CMC development include:

  • The need to scale up from laboratory to commercial production.
  • Ensuring consistent and accurate method transfer between labs.
  • Navigating complex regulatory requirements and guidelines.
  • Addressing resource limitations such as access to specialized equipment and expertise.
  • Effectively managing communication and collaboration across different time zones. 

These challenges require careful planning, coordination, and expertise to ensure successful CMC development and regulatory approval.

With our global network of advanced laboratories and highly experienced scientists, BioAgilytix allows sponsors to effectively address these and other challenges facing successful CMC development.

Scalability:

Our global network of labs supports scaling up from laboratory-scale to commercial-scale production, offering expertise in process optimization and scale-up strategies.

Method transfer:

Our network enables seamless transfer, validation, and implementation of analytical methods across different sites, ensuring consistency and accuracy.

Resource availability:

BioAgilytix provides sponsors access to a wide range of innovative technologies, instrumentation, and expertise, ensuring availability of specialized resources.

Regulatory compliance:

BioAgilytix stays up to date with regulatory standards across regions and countries, leveraging our global network to ensure compliance throughout the process, worldwide.

Communication:

BioAgilytix efficiently manages communication and collaboration across different time zones, leveraging our global network to provide support and maintain effective communication with sponsors.

Dose Formulation Analysis

Dose confirmation analysis for formulation samples is an important part of any successful GLP study and is required by the United States Food and Drug Administration (USFDA) for formulations dosed in toxicology studies. We provide high quality, preclinical dose formulation analysis for both GLP and non-GLP studies, to ensure your study starts off on the right track.