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PHARMACEUTICAL SERVICES

cGMP Manufacturing

Introduction

Microbial custom 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 cGMP standards. Our teams operate on a 24-hour, 7-days/week schedule throughout the year.

Our site has production areas dedicated for pharmaceutical manufacturing. These areas (classified environments in downstream process area) comply with cGMP requirements (ISO). United States and European authorities (FDA, AIFA) as well as customers on routinely basis audit the site.

The main expertise of Capua BioServices in pharmaceutical services relates to technology transfer and the manufacture of small molecules, recombinant proteins (mainly oral usage) and enzymes.

 

"OUR EXPERIENCE IS YOUR SOLUTION"

ANALYTICAL SERVICES & QUALITY CONTROL

Quality, Reliability and Flexibility

Our QC team works closely with Manufacturing, Quality Assurance, and Process Development teams to ensure the success of the cGMP manufacturing operation according to our customer’s requests. Our QC technicians provide expertise based on extensive experience in cGMP production of clinical and commercial products.

QC tests all manufacturing processes at various points, including raw materials, in-process and release samples, and routine facility related samples (environmental monitoring, water systems, clean steam, clean gas, etc.). All quality related analyses are under strict cGMP requirements from raw material to final product release.

Method validation is performed according to ICH Q2 (R1) guidelines to satisfy the requirements of the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Close collaboration with the method development team and continuous monitoring ensure the efficency of validation protocols. Clients are assured of reproducible results and validation support, from development to approval to commercialization of their products. Quality is core to everything we do throughout the analytical support relevant to your project.

Capua BioServices offers stability testing according to ICH guidelines.

QUALITY ASSURANCE & REGULATORY AFFAIRS

Providing product support

Quality Assurance

Capua BioServices is committed to provide products and services with the highest possible quality, fulfilling your needs and expectations. We operate a local quality management system in compliance with local law, international standards and regulations (e.g. ICH, PIC, cGMP) as outlined by regulatory authorities such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Operating as a custom manufacturer we are committed to our customer success ensuring that project meets full regulatory compliance according to the customer scheduling.

Regulatory Affairs

Capua BioServices cGMP license covers both clinical and commercial supply of Active Pharmaceutical Ingredients. Capua BioServices facility is approved by the FDA since 1970 and is also inspected on a regular basis by the Italian regulatory authority (AIFA) in accordance with EMA regulations and FDA CFR21. Recent inspections (FDA: 2009, 2012, 2015 and 2017; AIFA: 2013 and 2016; Ministry of Health: 2014 and 2017) were successfully passed without any critical observation.

Capua BioServices provides regulatory support for Drug Substances with respect to manufacturing (CMC sections and IMPD) for clinical and commercial submissions (CTD). We work in close collaboration with our customers providing the required documentation for regulatory filings including Investigational New Drug (IND) applications, Biologic License Applications (BLA), New Drug Applications (NDA), and marketing authorization (ASMF).

 

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 and engineering campaign
Validation 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 step.

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.