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 Development Philosophy
Our Analytical Development philosophy has its core one main objective: developing and utilizing methods that have built-in success strategies for your program.
Process Development should be driven by an understanding and/or expectation of the product’s quality attributes
Design methods to have a line of sight from early process development through all stages of cGMP manufacture
Ensure consistent analytical data throughout the clinical development lifecycle
By working closely with your team we ensure that we are using analytical methods to optimize the expression and purification of your protein with desired qualities or properties. We understand how important the adoption of methods into routine cGMP manufacturing is for long term program success.
What to look for in an Analytical Partner?
As you make your CDMO selection, consider how Analytical Development (is):
- Driven by science, innovation & regulatory factors
- Building quality into the product, maximizing the design space and minimizing risk in method performance
- Driven by business factors, with a line of sight to reduce development costs, resources, and timelines
At FUJIFILM Diosynth Biotechnologies, this is how we approach and differentiate our Analytical Development as a CDMO.
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.
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.
At a glance, our core capabilities include:
We offer comprehensive capabilities that include having the ability to do:
- Agilent 1100/1260 HPLC – DAD/FLD/RI/ELSD
- Waters H-Class UPLC – TUV/FLD
- Dionex ICS-3000 PAD/ECD
- Traditional gels, blots
- CE-SDS, CE-LIF, iCE, Maurice
- Bioanalyzer, LabChip GXII
- Cell Based Bioassays (baculovirus titration, receptor activation, cell proliferation, inhibition)
- FACS, ELISA, FRET, AlphaLISA, Octet, Biacore
- Fc Receptor
- Antibody-dependent cell-mediated cytotoxicity (ADCC) assay
- Complement-dependent cytotoxicity (CDC) assay
- ESI UPLC/HPLC MS/MS and MSE and 2D M-Class UPLC
- Intact Protein Characterization
- Confirmation of Primary Sequence
- Identification of Post-Translational Modifications
- Orthogonal Host Cell Protein Characterization
- Sequence Variant Analysis
- Site Specific (N- and O-linked) glycoprotein characterization
- Automated Identification of N-Glycans Using UNIFI®
- Post Translational Modifications
- Chemical Modifications
- DNA (pPCR), HCP, ProA
- detergents, PEG, PEI, Antifoam