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NON-PHARMACEUTICAL SERVICES

Food grade manufacturing

Capua BioServices is set up as a multi-purpose facility, offering custom microbial development and manufacturing. We offer dedicated solutions for proteins, (high-value) small molecules and microorganisms for applications in pharmaceutical, food, feed and other bio-industrial markets. Capua BioServices can provide a fermentation capacity up to 1.400 m3 with associated recovery and purification equipment.

The site has an integrated wastewater treatment plant as well as a solvent recovery area. Our teams comprise a dedicated analytical group as well as all other service functions. The site can transfer and optimize process unit operations. We can operate under ISO standards and Food standards. Our teams operate on a 24-hour, 7-days/week schedule throughout the year.

Areas dedicated to food grade manufactoring comply with the highest hygiene industrial standards.
Strict HACCP programs are in place for controlling microbial, chemical, physical and allergen contamination.

The main expertise of Capua BioServices food grade manufactoring relates to technology transfer and the manufacture of small molecules, microorganisms and enzymes.

ANALYTICAL SERVICES & QUALITY CONTROL

Quality, Reliability and Flexibility

Quality is built into all products and services provided by Capua BioServices. Our technicians interact directly with clients to understand their specific requirements for product quality and consistent product performance. We have experience in working with quality requirements from industrial grade to food grade (infant formula, allergen-free, kosher and halal).

Method implementation is performed according to ICH Q2 (R1) guidelines. Close collaboration with the method development team and continuous monitoring ensures the efficiency of implementation protocols. Clients are assured of reproducible results, from development to approval to commercialization of their products. Quality is core to everything we do throughout the analytical support relevant to your project.

The experience and support provided by our team ensure that products are manufactured in the most cost-efficient manner, without compromising on quality and safety. We strongly believe that the right analytical support  is crucial during the different stages of your project. Therefore Capua BioServices offers a broad range of chemical and biological analytical techniques, to fit the needs and quality requirements of your project.

"OUR EXPERIENCE IS YOUR SOLUTION"

QUALITY ASSURANCE

Providing product support

Capua BioServices is committed to provide customers with products and services with the highest possible quality, fulfilling their needs and expectations.

This goal is achieved operating the quality management systems in compliance with local law, international standards and regulations (e.g. ICH, PIC FSSC GMP, HACCP).

Operating as a CMO we are committed to our client’s success ensuring that projects meet full regulatory compliance according to the customer scheduling. 

Capua Bioservices facility is regularly inspected by Orthodox Union and HFFIA organizations for Kosher and HALAL certifications and the site is FSSC 2200 certified.

Support to our clients is assured also in terms of equipment qualification, equipment cleaning procedures validation and processes qualification. High attention is also given to the production environment with development of strict environmental monitoring program.

PROJECT MANAGEMENT

Your project in our capable hands

Capua BioServices has extensive experience in working with customers on projects from all over the world. Between 2015 and 2018, more than 20 projects have been implemented by our highly-skilled project teams. These projects were executed within all different stages of the project/product life cycle in food and bio-industrial applications: from R&D, to pre-registration, to post-registration up to commercial supply.

We work with interdisciplinary project teams; linking our experts directly to your experts. Our projects are coordinated by a dedicated project manager and account manager; keeping track of the progress, while building trust and relations. 

Projects are managed by a joint agreed project plan, using a milestone-based, stage-gate approach. Open communication, setting joint objectives and managing mutual expectations are key to the success of a project.

PROCESS DEVELOPMENT

Scale-up & Scale-down

Capua BioServices offers process development services at lab and pilot scale to support seamless technology transfer, scale-up , scale-down and continuous improvements. Our complete large-scale capabilities are available at lab and pilot scale, including spray-drying.

Our process development laboratory offers upstream solutions from shake-flask, to 2L autoclavable fermenters, to 15L in-situ sterilizable fermenters with control systems, up to 3000L scale. The downstream processing equipment includes bench centrifuge, high-pressure homogenizer, multiple configurable automatic skids for microfiltration (MF) and ultrafiltration (UF), a GE AKTA pure chromatography system up to 150 ml/min with 16-100 mm diameter columns, several process vessels and pumps.

Basic in-process control is arranged within the process development laboratory with UV-VIS, HPLC, pH, conductivity, and refractometry. The lab is served by HVAC, filtered industrial steam, deionized water, brine and oil-free compressed air. Our highly-skilled people operate the lab set-up in the most flexible manner to adress the different needs of various projects throughout the different stages of process development.