Microbial fermentation continues to be an important upstream bioprocess for the production of conventional and next-generation biologics. Capua BioServices continues to invest in the latest laboratory and process-scale equipment and analytical capabilities to support modern fermentation.
Why Fermentation?
Biologic drug substances can be produced using cell-culture or microbial fermentation processes. For many larger biomolecules, cell culture is the method of choice. Microbial expression using bacteria, yeast or fungi is generally preferred for smaller biologics. The microbes used in pharmaceutical manufacturing are genetically engineered to produce large quantities of biologically active substances, including peptides, proteins, cytokines, growth factors, plasmid DNA, single-domain antibodies, peptibodies and antibody fragments. For these compounds, microbial fermentation offers several advantages over cell culture. The processes are typically much shorter, less complex and generally more economically attractive. Media components applied are often free from animal-derived components, and associated costs are much lower as compared to cell culture.
Fermentation Focus
Capua BioServices (formerly known as Patheon Capua and DSM BioSolutions) is an independent, global provider of microbial custom development and manufacturing services. Located in Capua, near Naples, Italy, we began operating as Capua BioServices in July 2015. We have more than 50 years of experience applying bacterial, yeast and fungal systems for the production of proteins, enzymes and small molecules at the lab, pilot and commercial scales.
We have an extensive track record of developing and optimizing robust, cost-effective, high-quality microbial fermentation processes for the pharmaceutical and food markets, as well other specialty applications. Some of the microbes with which we have expertise include Escherichia coli and Bacillus spp, Saccharomyces spp, Klyveromyces lactis, Pichia pastoris and Aspergillus spp. We also have the requisite permits and capability to work with GMO strains.
Microbial expression using bacteria, yeast or fungi is generally preferred for smaller biologics.
Laboratory Investments
Recently, Capua opened a new laboratory facility that further strengthens our ability to conduct lab and pilot-scale activities. The investment is intended to better support the onboarding of new projects and facilitate the development of processes from the start that will be practical for sustainable, large-scale manufacturing.
The addition of the new lab increases Capua’s flexibility and enables us to provide a more complete on-site offering and support seamless technology transfer. The new facility includes upstream, downstream and basic in-process control areas. Upstream equipment includes shaker-incubators, autoclave, biohazard hood, several autoclavable (2L) and in situ sterilizable (15L) fermenters with control system, while downstream includes large-capacity bench centrifuge, high-pressure homogenizer, multiple configurable automatic skids for microfiltration and ultrafiltration, GE AKTA pure chromatography system up to 150 mL/min with 16 to 100 mm diameter columns, and several process vessels and pumps. Basic in-process control is present directly inside the facility with UV-VIS, HPLC, pH, conductivity, refractometry, multiple scales, etc. The lab is served by HVAC, filtered industrial steam, deionized water, brine and oil-free compressed air.
Expanded Spray Drying Facility
In 2017, Capua BioServices opened a new spray drying facility to provide our customers with a technical and economically attractive alternative to lyophilization, crystallization and micronization. Spray drying allows the production of stable formulations of dry powder proteins, peptides, monoclonal antibodies and vaccines and can often enhance the bioavailability of poorly soluble compounds. It also enables precise engineering of particle size and the embedding of microencapsulation technology. The facility includes pilot-scale equipment and a cGMP spray drying suite with evaporation capacities of approximately 3-5kg and 100kg of water/hour, respectively. Our spray drying services include excipient and solvent screening, process parameter optimization, scale-up and cGMP spray drying, stability testing and QA release.
Capacity and Flexibility
In order to best support our customers, Capua BioServices has designed its facility
to be very flexible and developed expertise in a broad diversity of process types and processing technologies that can be applied at development to commercial scale. Our site in Capua contains dedicated manufacturing areas for pharmaceutical products and is regularly audited by the US FDA, EMA and specific European country authorities. With a total fermentation capacity of about 1400 m3 spread over two separate fermentation areas, it is one of the largest independent beta-lactam-free microbial contract manufacturing facilities in Western Europe. The site also houses comprehensive downstream processing, formulation and final product filling and packaging areas. Capua’s seven (soon to be eight) distinct recovery/purification plants include a large diversity of unit operations, which are designed to handle multiple projects in parallel from lab scale to pilot scale to commercial scale. Our development, optimization and commercial production activities are supported by an on-site GMP-qualified QC laboratory where biological and chemical assays are performed for raw material, in-process control and final product release testing.
Unique Position
Product development, applications and regulations in the pharmaceutical and food industries are getting closer and closer. More often, it may be unclear whether a particular product is a medicinal product, food product/supplement, cosmetic, medical device or biocide. With quality systems and certifications in place to manufacture medicinal products as well as food-grade products, we are perfectly experienced and set up to support clients navigating through the landscape of these so-called “borderline products.” Capua BioServices is GMP FDA approved since 1970 and FSSC 22.000 certified since 2016.