Process Development

Florida Biologix® has excellent technical capabilities to perform Assay and Process Development1 to ensure transfer of technology to FDA-approved cGMP standards before full-scale manufacturing. Our scientists will work closely with yours to identify appropriate raw materials and/or supplies and to seamlessly transfer or develop a robust, scaleable, compliant and cost-efficient process.

We work with you early on to define the critical parameters2 to ensure the process is sufficiently robust and reproducible to be transferred on to Phase III cGMP production.

Pre-clinical/toxicology material is also generated in our Process Development laboratories. In addition, non-GMP research studies can be conducted here.

Activities

Batch Record Development

Florida Biologix® has highly experienced scientists who work closely with manufacturing personnel and Quality Assurance in the development of thorough and high-quality process development protocols which are used to write Production Batch Records3 (written instructions covering each stage of production, storage, packaging, and quality control of a biologic) when the process is transferred to cGMP manufacturing.

Cell Culture Development

Florida Biologix will optimize a cell line’s culture conditions and growth parameters for optimal protein production or growth. Our process development scientists can help you select the best expression systems and host cells for a particular cloned gene.

Florida Biologix can:

  • Work with all major mammalian cell lines (HEK, CHO, T-cells, lymphoblasts, stem cells etc.) to develop and scale-up processes
  • Characterize cell lines, assess cell line productivity and stability
  • Develop cell-based assays for cell therapies
  • Develop batch, fed-batch and perfusion processes using flasks, roller bottles, cell factories, disposable bioreactor systems
  • Optimize and/or screen various culture media
  • Adapt cells to serum-free or protein-free media
  • Develop cell feeding strategies
  • Evaluate various cell culture and bioreactor systems

Purification

Our scientists can develop a new purification process, verify and scale-up a transferred process, troubleshoot and optimize column and filtration conditions.

  • Column chromatography- affinity, HIC, IEX, SEC etc.
  • Filtration – TFF, ultrafiltration, diafiltration

Analytical Development

Our scientists develop assay methods that are transferrable to the Quality Control department for qualification and validation for cGMP production.

  • Chromatographic methods (HPLC) - affinity, IEX, SeC, reverse phase etc.
  • Electrophoretic methods - SDS-PAGE, IEF, Western blot etc.
  • Standard chemical, electrochemical and spectrophotometric methods
  • Assay to assess host cell protein contamination of final product

Troubleshooting, Product Formulation and Stability Studies

  • The "Lazarus" Processing Service for Cell Lines: This unique service aims to rescue our client's in-house cell lines infected with bacteria, fungi or mycoplasma4.
  • Conduct formulation studies to develop the best buffers and reagents
  • Develop and execute stability studies to determine storage temperature and time that the product can be held without losing potency

Please contact us for more information. Project specific proposals are provided upon request.


1Process development (PD) is an extension of the R&D activities which originally led to the discovery, characterization and isolation of a target biologic. PD is a prerequisite to cGMP manufacturing of the biologic destined to be used in human clinical trials. During the PD phase, methods and assays are developed and optimized to produce the target biologic in large scale and measure its activity, potency and other essential characteristics. In addition, the production, downstream purification methods, viral clearance approaches, and formulation are all developed and documented in preparation for the transfer of technology to full cGMP manufacturing.
 2"critical parameters" - written instructions covering each stage of production, storage, packaging, and quality control of a biologic
 3Production Batch Records - Although it is true that many details of processes will change between Phase I and Phase III, the fundamentals of the process have to be firmly in place during the production of the Phase I and II materials. A poorly defined process which has to be substantially changed in Phase III manufacturing is likely to yield products which may be significantly different in purity, activity, potency and quality from the lots used in earlier clinical phases.
 4"infected with bacteria, fungi or mycoplasma" - It is estimated that about 40% of all cell lines developed by universities and research foundations are contaminated with mycoplasma. Insidious bacterial and fungal contamination of cell lines is very common. In order to prepare a cGMP cell bank it is essential that the parent cell line be free of contamination by microorganisms.