JHL Biotech provides cell line cloning, process development, and manufacturing capabilities and services to emerging and established biopharmaceutical companies seeking to collaboratively develop, manufacture and commercialize new, high-quality, affordable biologics.
Beginning as early as antibody cloning or as late as commercial manufacturing, JHL will work with your team.
During this stage, a pair of cDNA sequences is identified: one heavy chain and one light chain each of an antibody that is either humanized or fully human, that binds the target of interest, that contains the ideal biological characteristics agreed upon by the Client and JHL.
Monoclonal Antibody Manufacturability and Protein Engineering
In this stage, the manufacturability of the cloned antibody is assessed and residues with undesirable features are corrected so that cloning and production CHO cell line will not become a problem.
Cell Line Development
During Cell Line Development, a production CHO cell line (as well as back up production CHO cell lines) with good expression level and growth characteristics is generated. The production CHO cell line is then used for the subsequent steps.
Master and Working Cell Banks
Master Cell Bank (MCB) and Working Cell Bank (WCB) are prepared for the selected cell line. Banks are prepared under cGMP manufacturing controls and tested according to ICH guidelines for viability, identity, and purity.
Cell Culture Process Development
Beginning with the assessment of the top clones from cell line development, the production culture process is developed using a combination of shake flask and controlled bioreactor studies. Samples from the cultures are evaluated for cell density, media/metabolite concentrations, and product titer and key product quality characteristics.
Purification Process Development
The goal of this stage is to develop a purification process capable of meeting the purity and process goals to enable the manufacture of cGMP Phase I material.
As the cell culture process is developed feedstock from cell culture studies is used to develop the purification process. In general, the purification process consists of harvest by depth filtration/normal flow filtration, Protein A affinity chromatography, ion exchange chromatography, virus filtration, and formulation by tangential flow filtration.
In the design and development of a protein formulation to achieve the goal of delivering biologically active drug product to the target site of action, the clinical indication(s), route of administration, and physicochemical properties of the drug are considered. The degradation pathways and their impact on stability are systematically analyzed for the selection of formulation excipients to stabilize the protein drug product during long-term, real time storage.
Beginning during Cell Line Development and continuing through process and formulation development, analytical methods, including those methods to be used as Quality Control assays, are developed.
Manufacturing, packaging and labeling of material for Phase I/II clinical trials must be done in accordance with applicable laws, regulations and guidances for those countries in which the clinical trials are conducted.
For Phase III clinical trials, materials will be manufactured, packaged, and labeled at our commercial manufacturing facility under cGMP.
Manufacturing, packaging and labeling of commercial supplies are done in accordance with the applicable laws, regulations and guidances and must follow the approved manufacturing process and attributes defined in your marketing application.