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NON-PHARMACEUTICAL SERVICES

Non-cGMP 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.

Our site has production areas dedicated for Food grade manufacturing. These areas comply with the highest hygiene industrial standards and strict HACCP programs are in place for controlling microbial, chemical, physical and allergen contamination.

The main expertise of Capua BioServices in non-pharmaceutical services 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).

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. 

PROJECT MANAGEMENT

Your project in our capable hands

Capua BioServices has extensive experience in working with customers on projects from all over the world. We work with interdisciplinary project teams; linking our experts to your experts. Our projects are coordinated by a dedicated project manager and account manager; keeping track of the progress.

A project plan is part of our services. Projects are managed using a stage-gate approach; managing milestones and deliverables. Open communication and managing expectations are key to the success of a project.
A typical project comprises the following project stages:
- Technology transfer
- Lab-scale and/or pilot scale experimentation
- Scale-up
- Consistency campaign
- Commercial manufacturing

Together with our customers, we define the suited form and frequency of the project communication structure. Ideally, this involves presence of your team at our location and vice versa.  At the end of every project stage, we jointly evaluate how best to proceed to the next stage.

PROCESS DEVELOPMENT

Research & Development

Scientific support at your service

Capua BioServices performs process research & development of new projects (upstream and downstream) and can support laboratory and pilot scale experimentation from 2-2000 liters on site.

Our equipment is set-up in a flexible manner to support our projects throughout the different stages of development. This allows us to be agile and flexible throughout implementation of your process in our facility.