DIATHEVA - Biomanufacturing of innovative diagnostics and reagents

GMP

DIATHEVA s.r.l. is committed to a system of quality management that will ensure our products and services exactly meet the requirements of our customers.
This is achieved by embracing the requirements of EN ISO 9001 Quality Management System and the principles of Good Manufacturing Practice (GMP). We will specify our quality requirements to our suppliers; and of our processes, to ensure that our products always conform to the specified standards and are produced in time to meet customer’s requirements.
We will continually strive to improve the quality of our products and services through a planned system of Quality Assurance Management that will cover every part of our business. Regular management reviews and quality system audits are essential part of this system.

The Quality Manual, Management Procedures and Standard Operating Procedures will comprise the core of our documented quality management system. All staff will understand that adherence to the documented procedures is a mandatory requirement. We will ensure that the education and training of all staff in quality matters is sufficient to maintain and improve quality and that every staff member recognises their own responsibility for quality improvement.

The role of the Quality Assurance Department is to co-ordinate the development and maintenance of the DIATHEVA s.r.l.’quality system. This is achieved by a combination of testing, validating, monitoring and auditing the materials, facilities, systems and procedures, which can influence product quality. The quality system is based on an integrated documentation framework of specifications, standard operating procedures and batch records supported by validated equipment, processes and trained operators. Management meets on a regular basis to review quality performance via quality indices e.g. customer complaints, rejected products, audit findings etc.
From this meetings quality improvement measures are agreed and implemented.

PROCESS DEVELOPMENT
Diatheva process development activities cover the full development cycle, from supporting early-stage discovery efforts through small-scale protein production to fully-integrated, comprehensive process development programs leading to cGMP manufacturing to process characterization and scale-down validation studies. Our Process Development group can screen production strains to select a cell line that will efficiently provide the best possible expression of your drug substance.  We develop processes to take advantage of methods, such as high cell density fermentation, to increase product yield and manufacture the best quality product in the most efficient way possible.  We have a deep knowledge and experience in the science and practice of biopharmaceutical drug development. Diatheva has extensive experience with microbial (E.coli) derived proteins. The Diatheva team has worked with protein production processes at all scales from laboratory and pilot to clinical scales.
SERVICES
Cell line development
Fermentation
Product recovery
Purification Technology
Transfer from PD to cGMP
Manufacturing and/or Scale Up
 
cGMP PROTEIN PRODUCTION
Diatheva has an high experience in producing recombinant proteins and antibody fragments for vaccines and diagnostics.  Our cGMP Manufacturing team specializes in the production of both protein and antibody fragments products for Phase 1-2 clinical studies.   The objective of upstream process development is to produce a robust and scalable process for the preculture and fermentation process fitting within Diatheva’s production facilities while maximizing productivity. Preferably a target product amount is agreed before development work is started to assess the practical and economic feasibility of the developed process. The development of the downstream process will start with the understanding of physicochemical properties of the product molecule. The process development team of Diatheva exploits these physicochemical properties to understand the feasibility of certain purification methods and consequently reducing the number of options to be investigated experimentally. Experimental works will be carried out to investigate the purification techniques that are highly likely to be efficient for this product molecule.
EXPERTISE
Recombinant Proteins
Fusion Proteins
Antibody and Antibody Fragments
Vaccines
EXPRESSION SYSTEM
Bacteria (Client-specified Strains)
 
QUALITY and REGULATORY
Quality is an integral part of Diatheva’s business practices. To achieve this end, quality management systems are implemented tocomply wiht internal policies as well as with national and international regulations and guidelines . Our scientists laboratory and manufacturing temas interact directly with clients to understand their specific requirements – ensuring products are manufactured to meet strict current Good Manufacturing Practice rrequirements and customer-defined specifications
EXPRESSION SYSTEM
Bacteria (Client-specified Strains)
Compliant with Applicable Regulatory Requirements
Dedicated project Team
Documented Quality System
Utility and Enviromental Monitoring
Preventative Mainteinance and Calibration Program
Materials Control
Production and process Control
Presonnel Training and Qualification
Continuous Evaluation and Improvement
Company certified
ISO9001
Certified N.
IT05/0576
info@diatheva.com
Phone (+39) 0721 830605
Fax (+39) 0721 837154
 
website netcompany
P.IVA.01403060427

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