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Analytical Development for microbial fermentation and cell culture

Analytical Development of biologics and vaccines is being driven by a new era of analytics and regulations. At FUJIFILM Diosynth Biotechnologies we are continually evaluating how best to utilize analytics for efficient, cost effective product quality driven and phase appropriate development of programs.

Our analytical team specializes in the development of assays to verify high-quality microbial expression of recombinant proteins to support scale-up and effective cGMP production.

Our team is very experienced with microbial fermentation, expression and the analytical development strategies needed through the process, from monitoring production to final release potency and impurity testing.

Our experts will provide you with fast and accurate assays to make sure the effective expression of high-quality products.

Guidelines

Process Development

  • Process Development should be driven by an understanding and/or expectation of the product’s quality attributes

Design Methods

  • Design methods to have a line of sight from early process development through all stages of cGMP manufacture

Analytical Data

  • Ensure consistent analytical data throughout the clinical development lifecycle

Choosing an experienced CDMO partner for analytical development

At FUJIFILM Diosynth Biotechnologies all analytical development activities are driven by:

  • Science, innovation & regulatory factors
  • Building quality into the product, maximizing the design space and minimizing risk in method performance
  • Business factors, with a line of sight to reduce development costs, resources, and timelines

Our core analytical competencies

Analytical Development of proteins is not without its challenges. This is due in part to the complex nature of molecules with multidimensional structures. As part of the development process all of these forms of a protein need to be considered:

  • Primary (amino acid sequence) and post-translation modifications (e.g. oxidation, glycosylation)
  • Secondary (highly regular sub-structures, e.g., α-helices/β-sheets)
  • Tertiary (three-dimensional structure of a single protein molecule)
  • Quaternary (multi-subunit complexes)

Other challenges include the fact that many proteins are rarely homogeneous, which will require multiple diverse tests to evaluate the protein heterogeneity. Having the expertise and a diverse array of cutting edge instrumentation to address these challenges is key as part of our Analytical Development offerings.

Decorative image for analytical competencies

Analytical Capabilities for Viral Products

Having the ability to measure the amount of infection in a viral product expressed through a Host/Virus system is essential for long term success. Some of the analytical challenges include determining what is the ration of infections versus non-infections viral particles. Our Virus Analytical Development team is very experienced with the analytical development strategies needed for viral products.

Summary of analytical development services

Method

  • Method Development
  • Method Qualification
  • Method Validation

Viral vaccines analytical characterization

  • Virus Strain Identity
  • Infectious titer measures
  • Viral particle population dynamics, cell substrate characterization

Chromotography

  • Agilent 1100/1260 HPLC – DAD/FLD/RI/ELSD
  • Waters H-Class UPLC – TUV/FLD
  • Dionex ICS-3000 PAD/ECD

Electrophoresis

  • Traditional gels, blots
  • CE-SDS, CE-LIF, iCE,
  • Maurice Bioanalyzer, LabChip GXII