Company

ABOUT US

With an illustrious 30-year history in pioneering research and development, SYMBIOSIS is your dedicated partner in providing cutting-edge analytical services tailored exclusively for the pharmaceutical and biotechnological industries. What truly sets us apart is our seamless end-to-end process system, not just ensuring operational efficiency but guaranteeing the precise fulfillment of customer requirements within the expected timeframes.
At the heart of SYMBIOSIS is an unyielding commitment to customer satisfaction, evident in our established track record, nurtured by our experienced and dedicated team of long-serving professionals. Their wealth of knowledge and expertise is seamlessly integrated into every project, ensuring unparalleled service.
Our recent integration into the MEX-Group marks a transformative phase, amplifying SYMBIOSIS's capabilities and resources. This expansion translates into a broader service portfolio, offering clients not just opportunities but a multitude of enhanced benefits. Clients stand to gain from our 30+ years of analytical testing expertise, fortified by GMP, GLP certifications and FDA approval. What distinguishes us is our tailored approach, driven by excellence in processes, communication, and quality.
SYMBIOSIS is more than a service provider; we are your dedicated ally in success. Choose SYMBIOSIS, where commitment meets excellence, for a partnership that propels your goals to new heights.

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