ANALYTICS MICROBIOLOGY MOLECULAR BIOLOGY

FOCUS ON COMPETENCE – 40 YEARS EXPERIENCEFounded in 1973, BioChem GmbH is an independent family-owned analytical contract laboratory, located in Karlsruhe, Germany, off ering 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 fi nished 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 specifi c national, international or customer-specifi c requirements.

As your business partner and internationally-oriented, modern full service provider BioChem GmbH continuously off er competent solutions for your projects.

Our scientifi c and practical experience combined with technical competence of more than 60 highly trained experts on board guarantee a maximum of quality, safety and effi ciency.

BioChem GmbH is GMP-/GLP-certifi ed as well as FDA-inspected and registered.

OUR PERFORMANCE – YOUR BENEFIT

Our scientifi c and practical experience combined with technical competence of more than 60 highly trained experts on board guarantee a maximum of quality, safety and effi ciency.

BioChem GmbH is GMP-/GLP-certifi ed as well as FDA-inspected and registered.

OUR PERFORMANCE – YOUR BENEFIT

OUR ANALYTICAL SERVICES

BioChem´s analytical laboratory off ers:

· 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· fi nished dosage forms· intermediates· excipients· raw materials

as well as· chemical· medical· cosmetic products

including· cytostatics· narcotics

ANALYTICS MICROBIOLOGY MOLECULAR BIOLOGY

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 valida-tes your method for identity, content (assay), purity, impurity, related substances or residu-als 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 (long-term, intermediate, accelerated, ongoing, in-use 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 mul-titude of physico-chemical, elemental or chromatographic techniques and procedures in-house, your advantage in using our services is obvious.

Method development from scratch and opti-mization 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 ap-paratus 2 (paddle) according to Ph. Eur./USP for single point dissolution during QC-release testing, 1-tier-/2-tier-dissolution and dissolu- tion curve profiling applying f2-calculation in all kinds of common media including surfac-tants or enzymes.

MICROBIOLOGY

OUR ANALYTICAL SERVICES

BioChem´s microbiological laboratory off ers:

· quality control release testing· EU reanalysis· microbiological methods - development - optimization - validation / verifi cation· sterility testing· bacterial endotoxin testing· microbiological contamination testing· identifi cation of microorganisms· effi cacy of antimicrobial preservation· microbial assays of antibiotics· environmental monitoring· in use stability test· detergent and disinfectant effi cacy· testing of biological indicators· microbial container closure integrity· registration support / expert opinion

for all pharmaceutical· fi nished dosage forms· intermediates· excipients· raw materials

as well as· chemical· medical· cosmetic products

including· cytostatics· narcotics

ANALYTICS MOLECULAR BIOLOGY

·

microbiology MICROBIOLOGICAL EQUIPMENT AND TECHNOLOGIES

Within our Microbiological Department – en-tirely 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 technolo-gies 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 pharmacopoei-al and customer-specific methods we have gained an extensive knowledge in develop-ment, 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 Depart-ment which was modernized in 2005.

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 contai-ner 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, sedi-mentation or surface contact plates as well as swab tests.

Evaluation, biochemical or molecular biologi-cal typing up to species level and classification of potential isolates complete our services.

DETERGENT AND DISINFECTION

To verify the efficacy of cleaning and disin-fectants 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.

MOLECULAR BIOLOGY

OUR ANALYTICAL SERVICE

BioChem´s molecular biological laboratory off ers:

· quality control release testing· EU reanalysis· molecular biological method - development - optimization - validation / verifi cation· PCR analysis of MOs and viruses· DNA, DNAse, RNA, RNAse detection· DNA / ATP / Protein quantitation· molecular weight determination· protein analysis and immunochemistry· identifi cation of MOs, GMOs and plants· capillary electrophoretic analysis· registration support / expert opinion

for all pharmaceutical· fi nished dosage forms· intermediates· excipients· raw materials

as well as· chemical· medical· cosmetic products

including· cytostatics· narcotics

ANALYTICS MICROBIOLOGY

molecular biology MOLECULAR BIOLOGICAL EQUIPMENT AND TECHNOLOGIES

Our state-of-the-art equipped molecular bio-logical 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 solu-tions 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 pharma-copoeial requirements are common well esta-blished practises.

As specialists in (q)PCR / RT-(q)PCR techno-logies 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 tes-ting 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 requi-rements 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, develop-ment, production or marketing.

WHO ARE WE?

BioChem GmbH is an independent, family-owned analytical contract laboratory located in Karlsruhe, Germany which has off ered high-quality labora-tory services and competence in all areas of ana-lytical, 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 Mass-mann († 1998), a medical specialist in pharma-cology and microbiology and a well-acknow-ledged occupational medicine expert.

BioChem`s laboratory activities started with the analysis of biological and microbiological parame-ters. 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 com-pany (GmbH, HRB 103147).

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 2005.

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 know-ledge and expertise, demonstrated in more than 40 years of long-standing, successful collabora-tions with our customers in Europe, USA and Asia is the reason why we enjoy an excellent reputa-tion as a full-service analytical contract labora-tory 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 specia-lists such as microbiologists, chemists, molecu-lar 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 diff erent international requirements.

BioChem GmbH is GMP-/GLP-certifi ed as well as FDA-inspected and registered. WHAT DO WE STAND FOR?

Shortly spoken: a scientifi cally-based, customer-oriented, cost-eff ective, high-quality service!

That is what we stand for - That is what we live!

WHAT ARE OUR CORE COMPETENCIES?

BioChem`s strongest and fi rst core compe-tence 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, identifi cation of microorganisms, effi cacy of antimicrobial preservation, microbial assay of antibiotics, environmental monitoring, detergent and disinfectant effi cacy, testing of bio-logical 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 fi lls, 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.

BIOCHEM – YOUR FULL SERVICE ANALYTICAL CONTRACT LABORATORY

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 fi ni-shed products of all dosage forms.

Our four main areas of expertise within the Ana-lytical 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 spe-cial storage conditions as e.g. 25°C/40% r. h..For more information please visit our website www.biochem.de.

The youngest but most upcoming third strong core competence started in the late 90´s and be-longs in the Molecular Biological Department.

At BioChem, you will fi nd a wide-spread port-folio of diff erent molecular biological procedu-res and technologies such as PCR-analysis of microorganisms and viruses, DNA-, DNAse-, RNA-, RNAse-detection, DNA-, ATP-, protein-quantita-tion, molecular weight determination, protein analysis and immunochemistry, identifi cation of microorganisms and genetically modifi ed 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 fl exibly

- we take care about solving any situation

- you participate in our broad network of professionals

OUR CORPORATE PHILOSOPHY

The main element of our philosophy is to provide a scientifi cally-based, customer-oriented, cost-eff ective and high-quality service.

Organized in a fl at 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 authori-ties and other related associations ensure that we remain at the forefront of science.

BioChem GmbH Daimlerstraße 5b D-76185 Karlsruhe

Tel. + 49 (0) 721 9737 0Fax + 49 (0) 721 9737 222www.biochem.debiochem@biochem.de

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