BioUETIKON can help companies scale up to clinical trial and small-scale commercial supplies. “BioUETIKON has the facilities as well as qualified and experienced personnel to convert scientific discovery into commercial supply of drugs, thus taking advantage of the growing multimillion-dollar global market in the pharmaceutical industry,” says Mike Mulcahy, managing director.
The company offers GMP-compliant mammalian cell cultures and downstream processing for development or manufacture of APIs. All of the cGMP manufacturing processes are fully validated and controlled using a comprehensive documentation system to ensure regulatory compliance.
Typical application areas would be recombinant proteins, cell therapy products, and mAbs. BioUETIKON also provides services for scale-up of mammalian or insect cell culture, purification processes, and joint R&D. The company will offer help in technology transfer of processes using dedicated project managers.
The cell culture team has expertise in cell banking and storage and in suspension and adherent mammalian cell culture and insect cell culture systems in batch, fed-batch, or perfusion modes in a range of bioreactors: two 10 L, a 130 L, a 20L SUB with larger capacity SUBs planned for later this year. They also have a track record in optimizing, scaling up, and validating cell-culture processing.
BioUETIKON also specializes in the design and scale up of protein purification to optimize yield and purity of the product. Robust and reproducible purification processes are developed while adhering to strict quality standards and regulatory guidelines.
The firm offers liquid chromatography techniques such as ion exchange, hydrophobic interaction, affinity, multimodal, and size exclusion, with associated filtration unit operations.
BioUETIKON’s facility comprises 12,500 square feet of total space. It has fully independent ambient and 4°C Grade C production environments. There are three separate cell culture suites to accommodate multiproduct projects with multiple air-handling systems.
There are also three downstream processing suites, two of which have a temperature range from 2–8°C. Added to this are distinct media prep, support, and cold storage areas. Utilities include a purified water system, centralized distributed gas, a central process alarm system, backup generators, and the full range of ancillary equipment. The company is currently investing in disposable technology, including single-use bioreactors.
Meanwhile, BioUETIKON’s analytical labs specialize in protein and peptide analysis including method development. Services include total protein-content estimation, immunoanalysis, endotoxin/bioburden, mass spectrometry, and cell-based assay. The latter two services are offered in collaboration with partners.
BioUETIKON’s latest contract is with Orthomimetics to help develop a process and produce a regenerative scaffold to reduce the need for joint replacements. The product is being designed to help surgeons treat joint injuries more effectively without the need for open surgery. It has already undergone preclinical testing and enter clinical trials later this year, aided by BioUETIKON’s input to process development and manufacture.