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Analytical & Formulation Development

We have comprehensive analytical and formulation services for cell and gene therapies and protein biologics for every product stage

Analytical Development Services

AGC Biologics develops analytical methods for product release, characterization, and process development support. Robust and validated release methods, including bioassays, are designed to ensure your product's identity, safety, purity, and potency.

Our in-house bioassay group specializes in the development and validation of cell-based assays. This speeds results and eliminates the need for third-party interactions.

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Comprehensive Analytical Capabilities

Titer, purity & identity
Process impurity measurements
Product aggregation
Structural characterization
Product stability & formulation
Next generation sequencing
Broad array of characterization assays in-house

Our broad analytical characterization capabilities allow us to characterize carbohydrates, verify primary structure, identify post-translational modifications, and more. Our methods are applied to final product characterization, reference material qualification, and comparability studies.

We routinely coordinate our protein, cell therapy, and viral vector characterization activities with Process Development to monitor quality attributes throughout the development process.

With our talented staff, fully equipped labs, and extensive experience with molecules from antibodies to complex glycoproteins, to cell therapy and viral vector products, AGC Biologics is your number one resource for analytical characterization. 

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Whether you’re starting from scratch, have a partially developed method, or are transferring to a fully developed method for validation; we reliably design, troubleshoot, and develop a method for standardized cGMP release of validated results — backed by the statistical power you need.

Bioassay development capabilities include: 
  • Molecular Bioassay Development
  • Quantitative ELISAs for titer determination
  • Potency testing for ELISAs (in direct-binding or competition format), Cell Therapy drug substances
  • Biacore
  • Enzyme assays
  • Mycoplasma PCR (Cell Therapy)
  • Cellular Bioassay Development

    • proliferation, viability, signal transduction, apoptosis, reporter gene assays, and CDC assays

    • Ability to create release-ready cell banks

  • RCL Molecular assay for cell therapy (a part of a comprehensive QC testing panel)
  • Transgene functional assay (a part of a comprehensive QC testing panel)
  • Transgene-client-specific Assays for vector products
  • Replication competent AAV (RC-AAV) assay

Our comprehensive suite of analytical and bioassay development services enables us to provide our clients with validation data and full documentation to meet all cGMP, ICH, and international regulatory authority requirements.

We conduct stability studies to determine shelf life for active pharmaceutical ingredients (API), intermediates, drug products, placebos, and reference standards. In addition, we can design stability studies to meet your specific requirements.

Our stability capabilities and assets include:
  • Customer reviewed and approved stability protocols
  • QC and QA reviewed Certificates of Analysis provided at each time point
  • Capacity to support all ICH long-term, intermediate and accelerated stability conditions
  • 24-hour monitoring of all stability chambers and freezers with emergency backup

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Key Analytical Development Capabilities

  • Potency assays

  • Carbohydrate analysis (quantitative sialic acid and monosaccharide analysis, N-glycan profiling)

  • Protein intact mass profiling by LC-TOF MS Peptide mapping by LC-MS/MS

  • SEC-MALLS for aggregate characterization

  • CD, fluorescence, and FTIR for secondary/tertiary structure characterization

  • HPLC and electrophoresis

  • Cellular-based assays and stability activities

  • Infectious viral titer

  • Immunophenotype (for potency and identity) and FACS

  • GOI Sequencing & transgene function

  • Residual studies (pDNA, E1A/LTA, Bensonase, HCP)

  • 160+ custom in-house analytical tests for clinical and commercial supply for cell therapy and viral vector products

While our analytical development services are part of a comprehensive development and manufacturing program, they can also be offered as standalone services. We develop analytical methods for protein biologics, cell therapy, and viral vector needs. 

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Drug Formulation Development Services

Our formulation development experience enables us to provide innovative solutions to the specific challenges posed by your individual protein.

AGC Biologics develops formulations for liquid drug substance and drug product as well as lyophilized drug product (together with optimized lyophilization cycles).

We design broad, rapid excipient screening studies using Design of Experiment (DOE) principles to identify excipients and conditions consistent with maximum product stability.

We then systematically test these excipients and conditions in combination, using real-time and accelerated stability studies to deliver your perfect formulation.

  • Customized high-throughput fluorescent-based, pre-formulation screening

  • Formulations developed over a broad range of dose concentrations (micrograms to >175 mg/mL)

  • Wide array of analytical tools available to evaluate formulation stability, from HPLC to LC/MS peptide mapping

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Interested in learning more?

Contact our team
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View our Analytical, Formulation and Stability fact sheet

We pride ourselves on fast and flexible development to speed your product to market.

View fact sheet