Services

Process Development

Florida Biologix^® has unsurpassed technical capabilities to perform Process Development and technology transfer activities preceding full scale cGMP manufacturing. Our scientists will work closely with yours to seamlessly transfer and/or to develop a robust process.

These include:

Batch Record Development
Florida Biologix^® has highly experienced scientists who work closely with manufacturing personnel and Quality Assurance in the development of Production Batch Records (written instructions covering each stage of production, storage, packaging, and quality control of a biologic) and subsequent transfer of the process to cGMP manufacturing.
Process Design, Feasibility, Scale Up, and Process Optimization, Yield Enhancement
Our scientists will work with the client to design an efficient and economical process to produce the target biologic with the highest quality and yield.
Process Qualification and Critical Parameters Definition
Our scientists are well aware of the economic and regulatory impact of using a poorly defined process. Therefore, we work with you to evaluate the process and to define its critical parameters to ensure the process is sufficiently robust and reproducible to be transferred to Phase III cGMP production.
Viral Kill and Clearance Studies
Viral kill and clearance studies are essential components in the clinical development of biologics. Viral kill and clearance studies are conducted for RNA enveloped viruses, RNA non-enveloped viruses, DNA enveloped viruses, DNA non-enveloped viruses.

Infectivity plaque or foci assays are used to assess clearance of the virus
Cell Line Development and Media Optimization
We can engineer a new production cell line or optimize an existing one. Our process development scientists have technical expertise to help you select the best expression systems and host cells for a particular cloned gene.

Working with you to carefully select media, isolate producer clones, and optimize expression systems ensures that the desired biologic is produced at maximal yield and lowest cost.
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 mycoplasma.

Our scientists use a variety of techniques to rescue the contaminated cell line. These include differential centrifugation, recloning, subcloning, multiple drug cure, passage through immunocompetent allo(syn)geneic animals by forming and harvesting solid tumors or ascites, and a number of other techniques most appropriate for the cell line.
Subcloning and Serum-Free Adaptation of Tissue Culture Cell Lines
Our process development scientists will adapt cell lines (in suspension or adherent) to grow in serum-free or protein-free media if clients require.

This is a critical step prior to preparing certain cGMP Master Cell Banks. The adapted cells will be banked initially as a "PD Bank", tested for sterility and mycoplasma and subsequently released into the cGMP cell culture facility for the preparation of the MCB.
Molecular Biology: Vector Selection and Optimization, Subcloning, Transfection, and Expression Maximization in Mammalian Cells
Whether your product is a humanized monoclonal antibody or a recombinant protein produced by a host cell line, our scientists can work with the client to design and optimize the vector which would produce maximum yield of the active product in a reproducible and cost effective manner.