Manufacturing Solution

AnproTech performs in silico assessments to identify whether the potential sequence liabilities could lead to manufacturing challenges at a later stage.

The presence of any identified liability sites can be investigated with our extensive bioanalytical capabilities, or removed using our comprehensive protein engineering technologies.  

AnproTech can develop custom cell lines based on customers's need, expressing biologics ranging from antibodies to fusion proteins.  Multiple cell lines developed by AnproTech have progressed through to product manufacture and can be assessed in clinical trials. Combining cell line development with GMP manufacturing can save 4-5 months to IND. In addition, working with our partners, AnproTech offers cell line development services where we can develop cell lines from cDNA that you provide for your recombinant protein, antibody, or hybridoma and engineer a highly productive, stable cell line in CHO cells or BHK, NS0, HEK-293, SP2/0 cells.

Cell Banking Generation

AnproTech produces Master Cell Banks in its cGMP production area in 100, 200 and 300 vial configurations.

Cell Banking Characterization

The characterization will depend on the potential for endogenous and adventitious agents from the cell line, media and any prior manipulation before banking. AnproTech can manage the full testing requirements for cell lines before production of the clinical material.

Cell Banking Storage

AnproTech’s storage is in auto fill liquid nitrogen tank with 24/7 monitoring system. Back up cryostorage capacity is permanently available. Master cell banks are required to last the lifetime of the product and this is a sensible disaster recovery procedure.

Bench-scale fermentations are designed by AnproTech to identify the upper and lower limits for each parameter that will be suitable as a laboratory scale process for use in later phase development for retrospective validation of the upstream. 

Once bench-scale tests are completed, AnproTech produces a development cell bank ready for fermentations to assess cell line stability for protein productivity.

Clinical Considerations

• Ensuring from the earliest stage that any process developed is scalable, compliant, and economical for large-scale cGMP manufacturing 

• Producing a product that meets quality and regulatory requirements relative to safety, purity, potency, identity, and immunogenicity through rigorous characterization.

• Meeting these criteria requires both methods and processes must be developed as well as qualified and/or validated, as appropriate, during preclinical, early-stage clinical, and late stage clinical product development.

AnproTech produces robust, consistent and scalable processes with the goals of maintaining yield, purity and quality of the drug substance. AnproTech also has performed the manufacturing of mammalian cell culture derived biologics for use in toxicity and animal safety studies, and First in Humans (FIH) through to late Phase human clinical trials. 

Full Downstream Purification Capabilities

AnproTech has a broad range of experience with the following types of biologics: 

• Monoclonal antibodies, antibody fragments (IgG, IgA, and IgM subclasses)

• Complex biologics such as antibody fusion proteins and bispecific antibodies

• Recombinant proteins and fusion proteins

• Growth factors, cytokines, exosomes

• Enzymes

• Antibody erug conjugates

• Radiolabeled antibodies

• Other bioconjugates

Analytics

AnproTech has standard platform assays and the methods used for in-process testing and release of drug substance are qualified. The qualification is based on ICH guidance to show assay specificity, linearity and variability.

Quality

AnproTech has an established System of Quality to meet the quality and regulatory requirements of products manufactured for Phase I and II clinical trials meeting US regulatory standards.

Project Management

AnproTech manufacturing solutions are tailored for each project to ensure that the objectives are met or exceeded. Experienced project teams are assigned to each study focusing on progressing projects through to results.