ANALYTICS MICROBIOLOGY MOLECULAR BIOLOGY

Transcription

1 ANALYTICS MICROBIOLOGY MOLECULAR BIOLOGY

2 FOCUS ON COMPETENCE 40 YEARS EXPERIENCE Founded in 1973, BioChem GmbH is an independent family-owned analytical contract laboratory, located in Karlsruhe, Germany, offering high quality laboratory services and competence in all areas of physico-chemical microbiological molecular biological testing for the pharmaceutical, chemical, medical and cosmetics industry. The area of expertise covers quality control release testing, analytical development activities, EU-reanalysis and ICH-stability testing of raw materials or finished products of all dosage forms and additionally allows BioChem GmbH to analyze cytostatics and narcotics. We provide analysis according to Ph. Eur., USP, JP, BP, HAB, DAB, AMG, MPG, ChemG, OECD and EC directives as well as other specific national, international or customer-specific requirements. As your business partner and internationally-oriented, modern full service provider BioChem GmbH continuously offer competent solutions for your projects. Our scientific and practical experience combined with technical competence of more than 60 highly trained experts on board guarantee a maximum of quality, safety and efficiency. BioChem GmbH is GMP-/GLP-certified as well as FDA-inspected and registered. OUR PERFORMANCE YOUR BENEFIT

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4 OUR ANALYTICAL SERVICES BioChem s analytical laboratory offers: quality control release testing EU reanalysis stability testing and storage photostability testing analytical method - development - optimization - validation cleaning validation elemental analysis physico-chemical analysis electrochemistry and titration dissolution testing (paddle/basket) water analysis particle testing spectroscopic testing microscopic analysis registration support / expert opinion for all pharmaceutical finished dosage forms intermediates excipients raw materials as well as chemical medical cosmetic products including cytostatics narcotics ANALYTICS MICROBIOLOGY MOLECULAR BIOLOGY

5 analytics ANALYTICAL INSTRUMENTS AND TECHNOLOGIES As a full service provider BioChem has a broad range of high-tech analytical instruments and technologies established including chromatography - HPLC (UV-VIS-D, DAD, FD, RID, ELSD) - GC direct/headspace (FID, WLD, ECD, PND) - TLC - IC (anion, cation) AAS - graphite tube, flame, cold vapor, hydrid - microwave, high pressure and acid digestion UV-VIS- / FT-IR-spectroscopy microscopy with video documentation electrochemistry and titration particle testing (visible / non-visible) dissolution testing (paddle / basket) water analysis (TOC, conductivity, etc.) physico-chemical analysis - osmometry - disintegration - hardness - surface tension - etc. No matter if you are interested in standard routine pharmacopoeial testing or looking for a partner who develops, optimizes and validates your method for identity, content (assay), purity, impurity, related substances or residuals testing our recognized experts are at your disposal. We constantly establish new technologies and frequently bring our analytical equipment up to date. Please contact us if the technology you require is not listed above. STABILITY TESTING We offer all kind of stability studies (longterm, intermediate, accelerated, ongoing, inuse and follow-up) according to ICH including stress- and photostability testing. Storage chambers are computer-monitored and a 24/7 alarm system is in place: 25 C/60% r. h. 30 C/65% r. h. 30 C/75% r. h. 40 C/75% r. h. refrigeration (2-8 C) and freezer ( -18 C) special climatic conditions (e.g. 25 C/40% r. h.) on request OUTSOURCING POTENTIAL Since BioChem concentrates to keep a multitude of physico-chemical, elemental or chromatographic techniques and procedures in-house, your advantage in using our services is obvious. Method development from scratch and optimization including validation or verification according to current GMP guidelines are some of our strengths. BioChem also supports you in your cleaning validation activities. DISSOLUTION BioChem uses apparatus 1 (basket) and apparatus 2 (paddle) according to Ph. Eur./USP for single point dissolution during QC-release testing, 1-tier-/2-tier-dissolution and dissolution curve profiling applying f 2 -calculation in all kinds of common media including surfactants or enzymes.

6 OUR ANALYTICAL SERVICES BioChem s microbiological laboratory offers: quality control release testing EU reanalysis microbiological methods - development - optimization - validation / verification sterility testing bacterial endotoxin testing microbiological contamination testing identification of microorganisms efficacy of antimicrobial preservation microbial assays of antibiotics environmental monitoring in use stability test detergent and disinfectant efficacy testing of biological indicators microbial container closure integrity registration support / expert opinion for all pharmaceutical finished dosage forms intermediates excipients raw materials as well as chemical medical cosmetic products including cytostatics narcotics ANALYTICS MICROBIOLOGY MOLECULAR BIOLOGY

7 microbiology Microbiological equipment and technologies Within our Microbiological Department entirely classified as safety class 1 we are able to handle microorganisms of risk-groups 1 and 2. All activities are supported by a broad range of high-tech equipment and technologies including sterility testing with isolator technology - membrane filtration method - direct inoculation method bacterial endotoxin testing (LAL) applying - gelclot method - kinetic-turbidimetric method - kinetic chromogenic method microbial examination of non-sterile products - total viable aerobic count (TAMC/TYMC) - test for specified microorganisms identification of microorganism based on - colony morphology and growth - biochemical characteristics (e.g. API system) - molecular biological parameters (e.g. 16S-rDNA) microbial assays of antibiotics by - agar-diffusion method - turbidimetric method comparative release studies of antibiotics efficacy of antimicrobial preservation in use stability - by repetitive challenge test - by application-oriented simulation model experiments and assessments for a multitude of microbiological questions With more than 40 years of experience in applying different kinds of pharmacopoeial and customer-specific methods we have gained an extensive knowledge in development, optimization, verification and validation of microbiological methods. State-of-the-art laboratory Fully air-conditioned separate lab units, each dedicated to specific analytical procedures, are available in the Microbiological Department which was modernized in The best product safety environment is at your disposal. Equipment and production line qualification We offer the incubation and evaluation of media-fills and biological indicators as well as a specifically designed microbiological container closure integrity test (CCIT) applying e.g. Brevundimonas diminuta as well-proven test species. Additionally, our qualified staff performs on-site environmental monitoring at client facilities using air sampling techniques, sedimentation or surface contact plates as well as swab tests. Evaluation, biochemical or molecular biological typing up to species level and classification of potential isolates complete our services. Detergent and disinfection To verify the efficacy of cleaning and disinfectants on specific manufacturing surfaces used in the GMP environment we established a solid scientifically approved microbiological approach. We support you in optimizing and validating your cleaning and disinfectant procedures by microbial challenge tests.

8 OUR ANALYTICAL SERVICE BioChem s molecular biological laboratory offers: quality control release testing EU reanalysis molecular biological method - development - optimization - validation / verification PCR analysis of MOs and viruses DNA, DNAse, RNA, RNAse detection DNA / ATP / Protein quantitation molecular weight determination protein analysis and immunochemistry identification of MOs, GMOs and plants capillary electrophoretic analysis registration support / expert opinion for all pharmaceutical finished dosage forms intermediates excipients raw materials as well as chemical medical cosmetic products including cytostatics narcotics ANALYTICS MICROBIOLOGY MOLECULAR BIOLOGY

9 Molecular Biology Molecular biological equipment and technologies Our state-of-the-art equipped molecular biological department offers a variety of modern technologies supported by a broad range of high-tech instruments including (q)pcr Cycler micro plate reader - photometer - fluorometer - luminometer electrophoresis - capillary electrophoresis - isoelectric focusing - SDS-page - gel-electrophoresis gel documentation system (CCD) Within our molecular biological laboratory premises safety class S1 - our highly qualified and motivated experts can handle GMOs or other organism belonging to risk class 1 or 2. Pharmacopoeial techniques For years we have been successfully using several pharmacopoeial techniques such as enzymatic assays for activity determination immunological assays protein / DNA / RNA identification and quantitation using isoelectric focusing SDS-page Bradford / Lowry ELISA / EIA, nucleic acid amplification technique (NAT) Microorganisms, viruses and DNA-fragments We offer customer-specific individual solutions for identification and quantitation of microorganisms including GMOs or pathogenic germs human, animal and plant relevant viruses customer-specific DNA fragments Detection of mycoplasmas out of cell cultures and validation according to current pharmacopoeial requirements are common well established practises. As specialists in (q)pcr / RT-(q)PCR technologies we are able to perform highly specific analysis with a minimum of sample amounts. Medical device and lab device testing One of our core competence focuses on testing of medical devices and lab supplies e.g. pipette tips, microwell plates, reaction or PCR tubes as well as stents for absence of DNA / DNAse / RNA or RNAse as it is required by several directives and guidelines. Start-up or global player Depending on your project-specific requirements and irrespective of the life-cycle status of your product, BioChem and its highly experienced staff accompany and guide you through tasks related to research, development, production or marketing.

10 BIOCHEM YOUR FULL SERVICE ANALYTICAL CONTRACT LABORATORY WHO ARE WE? BioChem GmbH is an independent, family-owned analytical contract laboratory located in Karlsruhe, Germany which has offered high-quality laboratory services and competence in all areas of analytical, microbiological and molecular biological testing for the pharmaceutical, chemical, medical and cosmetics industry for more than 40 years. WHERE DO WE COME FROM? BioChem was founded in 1973 by Dr. Walter Massmann ( 1998), a medical specialist in pharmacology and microbiology and a well-acknowledged occupational medicine expert. BioChem`s laboratory activities started with the analysis of biological and microbiological parameters. Over the years, our analytical service portfolio was extended step-by-step: a variety of chemical and molecular biological testing procedures were added during the 80 s and 90 s. In 1981, BioChem was registered as a limited company (GmbH, HRB ). As the company kept growing, a new facility was set up and BioChem moved into a state-of-the-art laboratory in 1988 which was partly modernized and renewed in Nowadays, under the direction of BioChem s principal shareholder Dr. Ludwig Massmann, we are part of several internationally established business units which are consolidated within the BioChem Holding GmbH. WHAT ARE OUR ACHIEVEMENTS? Our extensive and continuously improving knowledge and expertise, demonstrated in more than 40 years of long-standing, successful collaborations with our customers in Europe, USA and Asia is the reason why we enjoy an excellent reputation as a full-service analytical contract laboratory that handles all kinds of products including cytostatics and narcotics which originate from the pharmaceutical, chemical, medical and cosmetics industry. The expertise of more than 60 in-house specialists such as microbiologists, chemists, molecular biologists, biotechnologists combined with a comprehensive network of high professionals allows us to serve all of your needs as a competent reliable and trustworthy partner. BioChem established already in its early years the highest quality standard which follows current GMP- / GLP-regulations and is set up according to different international requirements. BioChem GmbH is GMP-/GLP-certified as well as FDA-inspected and registered. WHAT DO WE STAND FOR? Shortly spoken: a scientifically-based, customeroriented, cost-effective, high-quality service! That is what we stand for - That is what we live! WHAT ARE OUR CORE COMPETENCIES? BioChem`s strongest and first core competence can be traced back to the early days in the 70 s the Microbiological Testing of a variety of samples. Sterility, bacterial endotoxin, microbiological contamination, identification of microorganisms, efficacy of antimicrobial preservation, microbial assay of antibiotics, environmental monitoring, detergent and disinfectant efficacy, testing of biological indicators or microbial container closure integrity testing are the main well established standard applications and are complemented by hygiene testing of client facilities or evaluation of media fills, just to mention some. Our clients also appreciate BioChem`s extensive experience in competent advisory service in all kinds of microbiological relevant topics regardless in which phase of product life cycle their project stays. The second strong core competence with more than 30 years of history can be found within the Analytical Department. Starting in the 80 s, BioChem took over more and more quality control release testing and analytical development activities as well as EU-reanalysis and ICH-stability testing of raw materials or finished products of all dosage forms. Our four main areas of expertise within the Analytical Department are physico-chemical testing, elemental analysis as e.g. AAS, chromatographic analysis by HPLC, GC, HS-GC, TLC or IC and stability testing according to ICH guidelines including special storage conditions as e.g. 25 C/40% r. h.. For more information please visit our website The youngest but most upcoming third strong core competence started in the late 90 s and belongs in the Molecular Biological Department. At BioChem, you will find a wide-spread portfolio of different molecular biological procedures and technologies such as PCR-analysis of microorganisms and viruses, DNA-, DNAse-, RNA-, RNAse-detection, DNA-, ATP-, protein-quantitation, molecular weight determination, protein analysis and immunochemistry, identification of microorganisms and genetically modified microorganisms and plants as well as capillary electrophoretic analysis. WHAT IS YOUR ADVANTAGE IN USING OUR SERVICE? Simply spoken: You will succeed with your project because - you will be in direct contact with our respective experts - our huge expertise gained over years by a multitude of similar challenges is available to you - if timelines are short, we support you overnight and weekends - we act and react flexibly - we take care about solving any situation - you participate in our broad network of professionals

11 OUR CORPORATE PHILOSOPHY The main element of our philosophy is to provide a scientifically-based, customer-oriented, cost-effective and high-quality service. Organized in a flat hierarchy, our well-experienced employees are our greatest asset. They keep our pronounced team spirit up and form the basis of our future development. Most of our staff have been with the company for many years. Continuous further education, participation in professional bodies, close liaison with authorities and other related associations ensure that we remain at the forefront of science.

12 BioChem GmbH Daimlerstraße 5b D Karlsruhe Tel (0) Fax + 49 (0) biochem@biochem.de DESIGN & PHOTOGRAPHY: