Newsletter. News from BSL BIOSERVICE. No. 2 - July 2014

Transcription

1 Newsletter No. 2 - July 2014 News from BSL BIOSERVICE we are pleased to announce our next newsletter in a new dress. Our ambition is presenting our future news in a more friendly manner. Many things have happened within the last months. We set new trends in genetic toxicology testing and in vitro alternative methods, we earned full AAALAC accreditation for our responsible animal care, we expanded our service portfolio by TOC analysis for production water, we hosted successfully our annual medical device seminar and we celebrated the official inauguration of our new bioassay laboratories. If you wish to read more about any topic just click on the related article below. We hope you enjoy reading this newsletter. Best regards, Your Team of BSL BIOSERVICE Current Trends in Genetic Toxicology Testing for existing and new chemicals The scientific discipline of genetic toxicology has played an important role in the safety assessment of existing and new chemicals during the past four decades. This field has undergone significant changes during this time, not only in its regulatory applications, but also in the tools and technologies employed to identify adverse effects. Now, the regulatory requirements are being harmonized globally, with emphasis on 3 Rs. For example, recent changes to ICH, ISO and OECD testing guidelines promote the integration of genetic toxicology endpoints (e.g., Comet, micronucleus, and gene mutation PigA) into 28 day-repeat-dose toxicology studies. A new guideline for the study of mutations in germ cells of transgenic animals (OECD 488) has been finalized. Finally, genetic toxicology is moving from a qualitative science to the quantitative assessment of dose-responses including the identification of point-of-departure to extrapolate effects to realistic human exposure levels.

2 BSL BIOSERVICE joined a network of research labs of the EU-NETVAL with a task to improve and create new guidance documents, training materials and tools to promote animal-free alternative methods. In order to develop our own strategy for 3R implementation the establishment and validation of alternative in vitro test methods are of key priority. The following tests are now under validation: comet assay in vitro and in vivo, transgenic animals assay, gene mutation PigA assay. However, also an improvement of existent in vitro test designs is an important issue at BSL BIOSERVICE. The implementations of aneugenicity determination in micronuclei with Fluorescence in situ Hybridization method (FISH) or high-through-put method with flow cytometer method are also under validation. A pioneer role in the in vitro alternative method and models development To address this, we offer a variety of cell-based alternative methods or models under GLP to examine the hazardous effects of chemicals, herbals, cosmetic and food ingredients or medical devices. The suitable test design is chosen depending on the material of the product and the aim of the study. We are establishing a method to assess the potential of a substance to cause a skin allergy in humans that incorporates a tissue model, a 3-dimensional human cell skin model that replicates key characteristics of normal human skin. RHE IL-18 potency test is a part of a validation project sponsored by industry (including BSL BIOSERVICE) and involving 9 partners and 4 skin models (Gibbs et al. 2014). It will replace the use of guinea pigs, rats or mice, which would have been injected with a substance or had it applied to their shaved skin to determine an allergic response. Skin or Eye models are also being used to replace rabbits that have traditionally been used to evaluate chemicals for their ability to corrode or irritate the skin or eye. Thus, in vitro 3D human tissue equivalents have made significant contributions to the reduction of animal use in industrial product development and regulatory testing, two of them are accepted from a regulatory standpoint as full replacement methods for testing dermal corrosion and irritation. Other models/methods are recommended as components of tiered testing strategies. Full AAALAC accreditation for responsible animal care and use The use of non-animal test methods, including in vitro studies, provides important tools to enhance our understanding of hazardous effects by chemicals and for predicting these effects on humans. The reduction of animals in toxicology research by encouragement of the development and validation of effective in vitro and alternative methods or models is one of the outmost concerns at BSL BIOSERVICE. BSL BIOSERVICE Scientific Laboratories GmbH have received full accreditation from the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International for their animal facility. AAALAC International is a private, nonprofit organization that promotes humane treatment of animals used for scientific purposes through voluntary accreditation and assessment programs. AAALAC stands for the Association for Assessment and Accreditation of Laboratory Animal Care. The accreditation confirms our strong commitment to a responsible animal care and use. The AAALAC council described BSL s animal facility as follows: Especially noteworthy were the very open atmosphere, making the site visit a joint effort to

3 improve the animal care and use program; the clean and well maintained facility; the state-of-the-art heating, ventilation and air conditioning (HVAC) system; the knowledgeable and motivated staff; the culture of care for the animals, evidenced by the general attitude of the staff and detailed score sheets to ensure careful use of humane endpoints. Animal welfare is a matter of great commitment for all BSL staff. Whilst some in vivo experiments cannot be replaced to date other experiments are accepted to get exchanged by alternative in vitro methods that BSL BIOSERVICE Scientific Laboratories GmbH is also offering. One of our declared objectives in terms of animal studies is to minimize the overall number of animals in use as well as their distress whilst guaranteeing high quality and validity of experiments. BSL BIOSERVICE have recently established and qualified TOC measurement using state-of-the-art equipment and are now able to offer TOC solutions to their clients in addition to other end points such as microbiological parameters to meet global regulatory requirements. TOC is the amount of carbon bound in an organic compound and is often used as a non-specific indicator of water quality or purity of pharmaceutical manufacturing equipment. A determined sensitivity limit, calibration and a system suitability test on a routine base are important to reassure quality. The test systems can be performed in compliance with GMP, GLP and ISO Microbiological Quality of Medical Devices - New ZLG Document recently published Water Testing Portfolio completed by TOC determination BSL BIOSERVICE provide analysis for compendial and production water. In the manufacturing process of pharmaceutical and medical devices water is a critical raw material under regular monitoring. Microbiological parameters, TOC (Total Organic Carbon), conductivity and chemical parameters according to the USP are enclosed into the overall testing program. Requirements of production water measurement have been drastically revised in the last decade. To improve global manufacturing efficiencies, the United States Pharmacopoeia developed new requirements for Water for Injection and for Purified Water, mandating Water Conductivity and Total Organic Carbon (TOC) tests to replace outdated wet chemical methods. ZLG have published a new document RDS 005 Anleitung für die Festlegung von Mindestkriterien zur mikrobiologischen Reinheit von Medizinprodukten in June This document had been prepared by the working group Microbiology of the HAK RDS (Horizontales Arbeitskomitee Reinigung, Desinfektion und Sterilisation) (BSL BIOSERVICE being a member of this working group). This document is a guidance for the procedure to establish the requirements for the microbiological quality for unsterile and sterile products. For medical devices being sold and used unsterile but may have a microbiological risk for the user the document suggests a (minimum) acceptance criteria for the final product. Depending on the usage of the medical device, e.g. contact to the body, acceptance criteria for the total aerobic microbial count and the test for specified microorganism are listed according to the recommendations of the European Pharmacopeia for pharmaceuticals.

4 In principal any medical device manufacturer has to evaluate the microbial risk of their product for the end-user within his risk assessment and has to define the requirements for the microbiological quality in his risk management. Open House Event for Bioassays Successful Medical Device Seminar In May 2014 BSL BIOSERVICE celebrated the official inauguration of its new laboratories for in vitro bioassays with more than 300m 2. From 21 to 22 May BSL BIOSERVICE successfully hosted its annual Medical Device seminar titled Biocompatibility - new trends and proven concepts in Munich. Around 40 customers attended the seminar and showed high interest in the presentations held by experts from BSL BIOSERVICE as well as by wellknown industry specialists. Existing and prospect customers were invited to an open house event with laboratory tours, poster presentations and an informal networking opportunity. Around 20 guests followed the invitation to celebrate with us and were impressed by the great opportunities our new laboratories offer. The first day covered interesting topics such as current information on the medical device directive, chemical characterization or suited in vivo and alternative in vitro test systems for biocompatibility examination. The second seminar day primarily dealt with topics about the biological safety and microbiological quality of raw material and semifinished products. All participants highlighted the profound praxis orientation of the seminar and enjoyed the associated networking event.

5 Upcoming Events Event Date & Place Further Information 9th World Congress on Alternatives and Animal Use in the Life Sciences August 2014, Prague, Czech Republic Eurotox 7 9 September 2014, Edinburgh, UK # 19 CIR 9 10 September, Barcelona, Spain Delegate BEBPA September 2014, Barcelona, Spain Aseptikon 30 September 1 October 2014, Frankfurt, Germany European Refinement Meeting October 2014, Munich, Germany Compamed November 2014, Düsseldorf, Germany Speaker Host Concept Heidelberg Seminar: Mikrobiologie für Nicht-Mikrobiologen 4-5 December 2014, Heidelberg, Germany Speaker Published by BSL BIOSERVICE Scientific Laboratories GmbH All rights reserved.