Company

ABOUT US

Integrating the expertise and experience of BIOPHARM of more than 30 years in research and development, SYMBIOSIS provides analytical services for the pharmaceutical and biotechnological industries. An extensive range of analytical solutions enable us to meet your product development objectives.
Our longstanding employees drive the success of our clients. You will profit through the wealth of experience our employees have and the knowledge they share. SYMBIOSIS has created a end-to-end process system which enables us to ensure your requirements are achieved to exact specifications within expected timeframes.
Central to our company philosophy is our clients’ satisfaction. This is manifested in a proven track record of succesful projects and long term partnerships. You will profit from our expertise in analytical testing for more than 30 years combined with a customer-focused approach driven by excellence in process, communication and quality.

Quality

The highest level of quality is pivotal for our and your success. As a cornerstone of our business, quality manifests itself through our integrated quality assurance system, quality control procedures and testing methods. GMP and GLP certified and FDA approved with over 30 years analysis experience we offer the knowledge and techniques to support your exact requirements in accordance with European and FDA quality standards.

Statement of GMP compliance

QUALITY ASSURANCE SYSTEM

Defined by comprehensive, well-structured standard operating procedures, our Quality Assurance (QA) system guarantees that all analyses are traceable, from the sample receipt to the performance of the study and reporting of results. Incorporation of current FDA and EMA requirements ensure that our QA system is constantly updated. Regular inspections by the authorities and audits from our customers confirm the high level of compliance with the current GMP and GLP regulations. Current procedures for OOS results, deviation handling and CAPA management form an integral part of our QA system. Before changes are implemented, their impact on quality must be evaluated; corresponding measures are laid down and processed. The success of our Quality Assurance system rests on the knowledge and dedication of our highly trained, long-standing staff. Ongoing training and knowledge transfer between project leaders and laboratory staff is core communication tactics in helping to ensure that our QA system has the trust and respect of our clients. All work is performed with qualified instruments. Our documentation is comprehensive and thoroughly controlled. GMP/GLP documents are archived for at least 15 years. A Site Master File according to EU ‘Site Master File - Explanatory Notes’ is available on request.

INSPECTIONS AND AUDITS

To supervise the compliance of our quality assurance system, regular inspections and audits are performed at SYMBIOSIS. Operating within a GLP framework we are familiar with periodic self-inspections – experience gained over many years. Our policy for the performance and documentation of internal inspections is laid down in SOPs. In addition a yearly program defining time lines and inspection areas is followed by our QA personnel. Routine inspections by authorities monitor the compliance of our QA system with cGMP and GLP. Furthermore our QA system is regularly supervised by our national and international clients according to their requirements. Observations from audits and inspections result in corrective and preventive actions, continually improving our QA system.
SERVICES
STABILITY TESTING & STORAGE
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BIOLOGICALS & PHARMACEUTICALS
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N-TERMINAL SEQUENCING
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METHOD DEVELOPMENT & VALIDATION
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Methods

Identity

Protein sequencing
(N- and C-terminal)

Mass spectrometry
(MALDI-TOF-MS)

Peptide mapping

Amino acid analysis

Spectrometry
(UV-VIS,IR, Fluorescence)

Isoelectric focussing
(IEF)

Western blot

Purity

Size exclusion chromatography
(SEC)

Ion exchange chromatography
(IEX)

SDS-PAGE

Thin layer
chromatography

Content

RP-HPLC

Protein determination
(CBB, BCA, UV)

ELISA

Titrimetry

Sialic acid determination

Impurity

Size exclusion chromatography

Ion exchange chromatography

SDS-PAGE

Thin layer chromatography

Physicochemical

Colour

Clarity/Opalescence

Visible particles

Osmolality

Melting point

Optical rotation

pH

Residual moisture

Loss on drying

Resistance to crushing

Safety

Bioassay

Immunogenicity

Functionality/Potency

Bioassay

Dissolution testing

Contact
Handelsstraße 15 D-69214 Eppelheim
+49 6221 5383-0

Quality Service

Made in Germany

Rhine-Neckar Metropolitan Region