European Biotechnology News Science & Industry
Personalised Healthcare: Medical and regulatory implications of companion Dx
Biotechnology: Biotechnica partner country Switzerland showcases its strengths
Bioservices: Recombinant glycosidases increase yields of active biological product
II Biotechnica 2013
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Nº 9 | Volume 12 | 2013
Biotechnica new processes developed by German researchers that use domestic waste as feedstock. There will of course also be a partnering forum. A third marketplace will deal with “Personalised Medicine”, a field in which pharma and diagnostics companies already generate revenues, but where many regulatory hurdles – like appropiate re imbursement for companion diagnostics – have yet to be cleared (see p. 39). Like at the other marketplaces, the personalised medicines space will offer a forum with speakers and panel discussions with players from biotechs, diagnostics developers and pharma giants.
Partner country Switzerland presents its strengths Intro
Meet the industry’s movers and shakers Some concepts are transforming the industrial biotech sector, and one of them is certainly the idea of the bio-based economy – or bioeconomy for short. The vision of using agricultural and forest biomass as well as biodegradable domestic wastes instead of oil for sustainably producing new chemicals, biomaterials and energy has already prompted industry and the European Commission to close a €3.8bn Public Private Partnership (see EuroBiotechNews 8/2013) aimed at bridging gaps in biobased processes. And there’s a lot of funding for the bioeconomy at the national level as well. Little wonder that the Hanover-based trade fair Biotechnica (8-10 October 2013) is placing special emphasis this year on innovations in the bio economy market, which is predicted to hit the a200bn mark by 2020. Now in its 20th year, the European life science event, which has up to now particularly attracted research tool providers and bio-regions as exhibitors, has launched a new approach aimed at bringing industry players in the emerging bioeconomy to Hanover. Two of its so-called ‘marketplaces’ – exhibition areas with lectures revolving around a specific research topic – have been dedicated to the bioeconomy.
The “Innovation in Food” marketplace will showcase innovations in food processing technologies and bioeconomy, whilst the “Industrial Biotechnology” marketplace will have a highlight on 8-9 October – a “Marketplace Forum” with lectures and a panel discussion featuring industry heavyweights such as Novozymes A/S and Clariant. An accompanying congress called “Biobased World” will present
For the first time in its history, Biotechnica has also named a ‘partner country’. Europe’s beating biopharma heart Switzerland will not only showcase its strengths in biotech and finance there (see p. 38), but will also for the first time present figures on its biotech sector that are based on the OECD definitions, thus providing international comparability.
Innovations and services at the forefront Besides new technologies like molecular imaging tests, next-generation sequencing and cell-based tests, the fair will also present the latest lab equipment innovations in proteomics, cell culture and other areas. Biotechnica is still a major showcase event for pharma industry-related services (see p. 34, p. 42), and singleuse equipment for up- and downstream processing will also be in the spotlight. After Biotechnica moved back in 2011 from an annual to a biannual cycle, a major question is whether the new concept implemented by board member Dr. Jochen Köckler will be more successful than that of his predecessor Stephan Kühne, who was responsible for past events. In 2011, Biotechnica profited from a tremendous upside trend, with 619 exhibitors (up from 500 in 2010) and 11,000 visitors (up from 9,500 in 2010). B
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Fight against protein micro-heterogeneity Assuring a correct post-translational protein glycosylation pattern is crucial when bio manufacturing monoclonal antibodies (mAbs), as it determines their biological function and stability in vivo. However, antibody yields of up to 10-15 g/l challenge the capacity of cellular systems, often causing microheterogeneities due to incomplete glycosylation. Industry has tried to address the issue by establishing cell lines that overexpress highly-specific sugar transferases in the Golgi apparatus, where the branched sugar scaffold is added to the protein. Roche Diagnostics has now come up with an approach that doesn’t require such licensed production cell lines. Adding glycosyltransferases to the final product yielded homogeneously glycosylated antibodies, improving the yield of active product. EuroBiotechNews spoke with Roche Diagnostics’ Operations Manager of Enzyme Production about the new approach, and what it could mean for antibody and biosimilar developers from the pharma and biotech industry.
Protein glycosylation is essential for functionality of most biologics and bio similars. How do producers today try to assure a correct glycosylation pat tern?
! Sobek: Two factors are important: the choice of a suitable production cell line, and optimisation of the reaction parame ters. Euro|BioTech|News
So where are the challenges?
! Sobek: Manufacture of recombinant proteins today delivers products with so-called microheterogeneities – a mixture of ful ly and only partially glycosylated pro teins. That implies two questions: How can I achieve the desired glycosylation, and how reproducible is the process? From our customers, we hear that re producibility in particular is critical. If you transfer the same cell line and re action conditions to another facility,
you often get a different glycosylation pattern.
What causes these microheterogenei ties?
! Sobek: The sequential attachment of sugars to the branched sugar chain takes place in the Golgi apparatus. Our customers be lieve that saturation effects there could contribute to microheterogeneities. That means the more protein is expressed, the more pressure is on the cell’s glycosyla tion system. This can lead to incomplete glycosylation of the protein due to a lack of activated sugars or insufficient enzy matic capacity of the sugar transferas es in the Golgi. Euro|BioTech|News
What does that mean for product yield?
! Sobek: If you have 5 to 15 different sugar struc tures, this has of course an impact on the yield of active protein. Everyone is
Harald Sobek is Manager of Enzyme Production at Roche Diagnostics Operations in Penzberg (Germany). Before starting his industry career at Roche, the microbiologist worked at the Gesellschaft für Biotechnologische Forschung (Society for Biotechnological research, GBF) in Braunschweig. He is an expert on the development and manufacture of enzymes.
therefore tr ying to push the process in the desired direction. This approach is being pursued by Roche Glycart and other companies that use cell lines overexpressing sugar transferases to increase the yield of fully glycosylat ed active proteins. It’s difficult to sepa rate heterogeneously glycosylated pro teins by chromatographic methods in the following downstream process. There fore, the final batch often contains a low concentration of active target pro tein.
Roche recently launched an initiative to solve the problem …
! Sobek: Another approach was originally requested by pharmaceutical manu facturers in the US: to optimise protein glycosylation in-vitro on the final prod uct. Customers asked if Roche could deliver sufficient amounts of glycosyl transferases for that purpose. That strategy is independent of the Glycart patents.
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Which markets is Roche focussing on? α 2,6
β 1,2 α 1,6
α 1,6 β 1,4
β 1,4 α 1,3 α 2,3
Structure of a bifurcated glycan with the enzymes involved
What does the process look like?
! SOBEK: That depends on the state of microheterogeneity. Sugar transferases have one advantage: they recognise the sugar structure where the sugar donor has to be attached. It’s a highly speciﬁc process. This translates into high selectivity and regiospeciﬁcity. As a consequence, you have very good control of the appropriate batch reaction. In experiments involving a galactosyltransferase reaction, we were able to couple 100% of the galactose involved to the protein. Euro|BioTech|News
tions in the terminal sugars. While the sugar core is usually in place, microheterogeneity occurs in the terminal branches. This is why the enzymes for the terminal bifurcations have to be launched first. The reaction gives a product homogeneity of 90%-100%. Subsequently, the customer has to carry out an antibody capture step. The whole process is economical and can yield a better product – one that is more active. I expect that will also be acknowledged by regulatory authorities.
! SOBEK: Currently we see two target markets: Big Pharma companies that produce biologics and in-house research. There are also requests from groups that want to use the enzymes at the analytical scale. These are completely new customers who have never thought of using sugar transferases before, even though they’ve been available for about 20 years. That’s because up to now glyosyltransferases were expensive due to the fact that they were produced in insect cells, which is really no easy task. At Roche Diagnostics Operations, we’ve developed a process to produce them in human HEK or CHO cells. The yielded amount of enzyme allows economical use for pilot and production scale. ?
Euro|BioTech|News So what are the next steps?
! SOBEK: Launch the ﬁrst wave of enzymes and watch the market. We’ve already identiﬁed our second wave.
When do you add the enzymes, and is it necessary to do it sequentially?
! SOBEK: We recommend adding the enzymes in a one-pot reaction after chromatographic puriﬁcation of the target protein. Euro|BioTech|News
You recently launched your first enzyme …
! SOBEK: Yes, we launched the alpha 2,6 sialyl transferase in June and we are going to bring the 2,3 sialyl transferase and the 1,4 galactosyl transferase to market together with the appropriate activated sugars. We selected these enzymes because microheterogeneities are most often related to varia-
Structure of the human alpha 2,6 sialyl transferase with bound CMP (cyan) in the active centre (yellow: glycane substrate (from Kuhn et al., Acta Cryst Sect D, 2013, in press). Analytical data suggest Roche’s enzyme catalyses full sialydation of bifurcated glycans.
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biotechnica partner country switzerland
A marriage made in biotech heaven
Letter to the editors
© Deutsche Messe
The Biotechnica – one of the most important biotechnology fairs in Europe – will take place for the 20th time this October in Hanover (Germany). Its organisers are using the anniversary to set a new course, and for the first time ever, the fair has chosen a partner country.
Switzerland is the first partner country ever at the Biotechnica fair.
Deutsche Messe Board of Management member Dr. Jochen Köckler explained the rationale behind the choice: “Switzerland is one of the strongest and most innova tive biotech centers in the world. We are confident the partnership will be a boon to economic relations between Germany and Switzerland, as well as the international biotechnology sector in general.” Switz erland has been one of the strongest ex hibiting nations at the fair for many years, and will use the chance to showcase the innovative power of its biotech industry, according to the Director of the Swiss Bio tech Association (SBA) Domenico Alexakis. The sector in the confederation is set up like that in many other countries, with re gional clusters and industry associations. There are four major clusters in Switzer land: the Basel Area, the greater Zurich Area, the region around Lake Geneva and Ticino (Bio Polo). They account for 80% of all biotech activity in the country. As in oth er parts of the world, most companies in these clusters are SMEs or start-ups. But
unlike most others, they benefit from the input of major pharmaceutical groups and first-rate public institutions. Swiss biotech can also count on very active participation in the medtech industry and the healthcare sector (with medical research conducted at both public and private hospitals and clin ics). At this year’s Biotechnica, apart from the companies that are the biggest testi monial of a functioning industry, Switzer land is promoting posters from academia and an ‘innovation wall’ to explain how pub lic and private research works in conjunc tion with applied technology transfer and start-up initiatives. The finance sector will also be repre sented adequarely by the Swiss Stock Ex change (SIX), which has seized a command ing position in Europe in the life sciences sector. At the communal, cantonal, region al and national levels, Swiss stakeholders have a reputation for working together to further biotechnology, not least because the field continues to be viewed as a cor nerstone of the Swiss economy. B
Article: “Striking a fair deal in orphan drugs”, EuroBiotechNews No. 6-7, Volume 12, 2013 “The article “Striking a fair deal in orphan drugs” is widely informative, yet the over view on so-called orphan blockbusters (ta ble 2) is partly misleading. First of all, it should be made clear that these are global sales figures. Most notably however, three of the eight listed drugs – rituximab, ranibi zumab and filgrastim – are orphan drugs in the US but not in the EU. Bortezomib has nei ther in the US nor in the EU orphan drug sta tus. While it is true that some orphan drugs are economically successful, the vast ma jority of these drugs realise rather low sales figures. Orphan sales statistics should not be pushed up artificially with non-orphan drugs. Orphan drugs are industry’s answer to medical needs of patients with rare dis eases and are often developed despite of their limited commercial potential. Inaccu rate statistics about orphan drugs will con fuse readers about this!” Dr. Sabine Sydow, Head of vfa bio
Table contents were taken from the Thom son Reuters report “The economic power of orphan drugs” (Oct. 2012). For more in formation on the former US orphan drug status of bortezomib, see: www.accessda ta.fda.gov/scripts/opdlisting/oopd/OOPD_ Results_2.cfm?Index_Number=163002. Table: Predicted total sales (1999-2030) of current orphan blockbusters Generic Name (Company)
A Rituximab (Roche)
A Ranibizumab (Novartis)
A Somatropin (off-patent)
A Imatinib mesylate (Novartis)
A Filgrastim (off-patent)
A Rec. Factor VIII/Octogog alfa
A Bosentan (Actelion)
A Bortezomib (Janssen-Cilag)
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Nº 9 | Volume 12 | 2013
BIOTECHNICA COMPANION DIAGNOSTICS
Medical & regulatory considerations Dr. Tobias Ostler, Dr. Detlef Niese; Dr. Regenold GmbH International Regulatory Affairs; Badenweiler, Germany
An exponentially expanding knowledge base on the molecular mechanisms that underlie disease has fundamentally changed the ﬁelds of disease taxonomy, clinical diagnostics and processes in medicines development. Here we look at how the new class of in-vitro diagnostics commonly called “companion diagnostics” inﬂuences the diagnostic process, and examine the regulatory considerations that seek to ensure they are used safely. The discovery of fundamental molecular disease pathways has allowed the
diagnosis of disease based on underlying mechanisms, as well as the devel-
opment of medicines targeting speciﬁc pathways. These developments are not only changing our understanding of disease overall, but are also resulting in a new disease taxonomy based on molecular disease mechanisms rather than affected organs and organ systems. The new approach to the classiﬁcation and diagnosis of disease has inspired a new generation of diagnostic tools based on mechanism-specific biomarkers. The approach of selecting a medicine speciﬁc for a disease mechanism based on the outcome of a diagnostic test (companion diagnostics) that is speciﬁc to the same process is now changing both the drug development process and patient
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Figure 1: Companion diagnostics complement rather than replace the classic process for finding a diagnosis and deciding on a treatment care signiﬁcantly. This approach is now widely known as “personalised” or “targeted” healthcare.
Medical diagnosis and treatment decisions But do companion diagnostics change the principle processes of diagnosis or the treatment of diseases? The objective of diagnostic procedures is to identify which disease/condition is causing a particular patient’s suffering, to assess the prognosis and to decide on the most promising therapeutic strategy. Throughout this process, the physician needs to collect, analyse and interpret a range of information for summary in a potential diagnosis that is weighed against alternative options. Then the physician decides on a deﬁnitive diagnosis that guides the treatment decision. Unfortunately, a varying number of patients diagnosed with the same disease will respond well to prescribed treatment. What on the surface appears to be the same disease (e.g. a particular type of breast cancer) can be quite heterogeneous when it comes to underlying molecular disease mechanisms. Companion diagnostics change this situation by identifying the molecular mechanisms responsible for disease in a particular patient, and determining a treatment regime targeting this mechanism. (See Fig. 1) Companion diagnostics therefore identify an optimal treatment option for a particular patient. But while including molecular
(companion) diagnostic tests in the standard process of differential diagnosis provides physicians with a powerful tool for prediction of potential outcomes, a number of caveats need to be taken into consideration: – Companion diagnostics are speciﬁc for a particular molecular pathway, target or disease mechanism – not necessarily for a particular medicinal product. – The same disease mechanisms can cause disease in multiple organs (e.g. breast cancer and colon cancer). – There may be more than one test or technology for the same biomarker. – It cannot be expected that for every disease mechanism or pathway a single diagnostic procedure or device will be sufﬁcient.
Regulatory considerations A companion diagnostic combines a validated biomarker that predicts patient response to a particular therapy with a robust test system (such as molecular imaging) for correctly quantifying or otherwise determining the biomarker in biological samples or in-vivo. False-negative or false-positive results of such a test system may be harmful for the patient. This raises a couple of regulatory concerns: – If a companion diagnostic was used during the development of a new medicine – either for selection of patients or for assignment to treatment – the companion diagnostic test may significantly influ-
ence the overall beneﬁt-risk ratio of this medicine as demonstrated during development. – The quality and clinical utility of a companion diagnostic test may affect the safety of the medicinal product for which it is used. Several regulatory authorities have issued guidance covering the co-development of a medicinal product and a companion diagnostic.[3,4,5] The label for a medicinal product could consequently restrict its use in patients with a particular test result – whether positive, negative, or above or below a particular level. If the safe and effective use of a medicinal product depends on the results of a companion diagnostic, authorities could assess the quality of an invitro diagnostic test according to regulatory standards for medicinal products. From a regulatory point of view, a companion diagnostics test should fulﬁll qualiﬁcation and validation criteria, which include demonstration of accuracy, precision and reproducibility of test results demonstrating the safety of the test procedure. Furthermore, clinical utility needs to be proven by demonstrating that in a typical clinical setting, the test effectively identiﬁes patient populations with superior safety and efﬁcacy for a particular treatment.
Companion diagnostics and targeted medicines When planning the development of a targeted medicine, a sponsor should consider whether it is likely that a particular companion diagnostic may have to be included in the product label. A diagnostic test will often have to be developed in parallel to a medicine’s clinical development. Though exceptions may be possible, the diagnostic test should be planned for launch when the medicine is launched. This co-development necessity raises several issues:[2, 3, 5] – In Europe, in-vitro diagnostics are medical devices, and as such follow a very speciﬁc regulatory process. This may involve authorities other than those responsible for medicinal products. – The development of the companion diagnostic should begin as early in the devel-
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BIOTECHNICA opment process as possible. However, risks for failure are high at this time. – During development of the target medicine, sponsors should not expect that a biomarker/companion diagnostic test fully separates responders and non responders. The same applies to biomarkers for safety (e.g. liver toxicity). – Speciﬁcity, sensitivity and positive predictive value for the outcome of a particular targeted therapy will never be 100%. Consequently, a companion diagnostics test is not able to predict success or failure of treatment in all cases.
The best of all worlds The success of targeted therapies depends on the availability, quality, and clinical utility of diagnostic tests that are speciﬁc for relevant disease mechanisms or drug targets. Like all other diagnostics, companion diagnostics conﬁrm the likelihood of the presence or absence of a
particular disease, and support optimal treatment decisions for a patient. However, the diseases diagnosed by companion diagnostics are deﬁned based on biomarkers that are related to molecular disease mechanisms and pathways. Such molecular diagnoses may include subsets of several diseases as currently deﬁned by pathology or clinical signs (e.g. HER2 expressing tumours affecting breasts and other organs). The overall beneﬁt-risk ratio of targeted medicines used in combination with companion diagnostics depends on several factors. These include: – Efﬁcacy, safety and quality of the medicinal product itself. – Quality of all steps and components of the diagnostic procedure, including but not restricted to the companion diagnostic. – Continued improvement and refinement of the diagnostic procedures and devices.
– Effective and continuously ongoing internal and external quality assurance of the diagnostic tools. References (1) EU Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices (2) European Commission Proposal for a Regulation of the European Parliament and the Council on in vitro diagnostic medical devices, 26 September 2012 (3) EMA Reﬂection Paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development (2010) (4) EMA Reﬂection paper on methodological issues with pharmacogenomic biomarkers in relation to clinical development and patient selection (2011) (5) FDA concept paper Drug-Diagnostic CoDevelopment; April 2005 Contact: Tobias Ostler & Detlef Niese Dr. Regenold GmbH Am Berg 4, 79410 Badenweiler, Germany e-mail: firstname.lastname@example.org
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CROs and the art of listening Big Pharma and biotech companies are increasingly outsourcing services to contract research organizations (CROs). Although market growth of preclinical services has remained relatively flat, 7% more toxicology testing services were outsourced in 2013 than in 2012. Because of this, WIL Research, one of the major global players in the preclinical CRO space, expanded services in Europe in June with the acquisition of the Lyon facility of Ricerca Biosciences. EuroBiotechNews spoke with the company’s CEO David Spaight about its acquisition, expansion strategy and capabilities.
What direction is the current CRO market taking?
! Spaight WIL Research is focused on the preclinical market. While the clinical market has shown double-digit growth in the last few years, the preclinical market can be described as fairly flat. We are coming off our third year of consecutive growth at WIL Research, which we believe has been at the expense of market share for a number of other companies operating in this space. Most R&D funding is still focused on late-stage products, but I think more research dollars are starting to shift to early-stage development. This will translate into segment growth in the market. Euro|BioTech|News
How is your company positioned in the CRO market, both in Europe and globally?
! Spaight: We are among the top three or four companies worldwide in the preclinical CRO market, and an industry leader in terms of customer satisfaction. WIL Research has multiple sites in the US, with facilities in Ohio, Illinois, North Carolina, and Penn-
sylvania.Looking at Europe, we currently have two facilities – one in The Netherlands, and a recently acquired facility in Lyon (France). We have complementary capabilities across all those sites, with many of them specialised in particular areas. If you take a look at Lyon, nearly 50% of the studies there are focused on work and activity involving biologics. We’ve also picked up on special capabilities. The facility in Illinois is a large molecule site focused on immunochemistry. We landed a group of pathologists through the North Carolina acquisition, and CMC activity is headquartered in Pennsylvania. All sites are now integrated under the WIL Research umbrella, so we have a footprint that can serve clients in both Europe and the US.
What’s your growth strategy in Europe?
! Spaight: From a growth perspective, we’ve had several strategic acquisitions over the last decade in both the US and Europe that strengthened our ability to offer an integrated safety assessment service to clients on a worldwide basis. We’ve also invested millions in expanding our capabilities. At the Netherlands site, we invested in doubling capacity back in 2008,
An expert on business integration, operational improvement and client relationship development, David Spaight joined the privately held global CRO, WIL Research, as CEO in April 2010. Spaight has more than 25 years of experience in the life sciences and analytical sciences industry. He was president of MDS Pharma Services, served as Senior VP at Fisher Scientific and put in 20 years at PerkinElmer Life and Analytical Sciences. In 2008, Spaight was elected as Chairman of the Board of the Association of Clinical Research Organizations (ACRO). At WIL Research, he was responsible for integrating five businesses – WIL Research Laboratories, LLC, NOTOX, Midwest BioResearch, Biotechnics, and QS Pharma – to provide greater value and full services to WIL Research clients.
and last year we expanded our chemistry capabilities there. So there’s been a lot of capital investment in the business to drive organic growth.
Which factors triggered your decision to acquire the Ricerca Biosciences facility in Lyon?
! Spaight: We spend a lot of time listening to our clients’ needs and analyzing the emerging trends within the pharmaceutical and biotechnology marketplace. One of those trends is the growth of biologics. After taking all that into consideration, we decided that we needed to expand our biologics capacity in Europe. Since closing the deal in June, the Lyon scientific team has helped fortify our biologics service offerings in Europe, strengthen our nonclinical safety
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Biotechnica assessment capability, and expand our portfolio of new specialty service projects.
What are the most important services you now offer as a result of this acquisition?
! Spaight: Many are complementary to services we provide in the Netherlands and the United States. For example, we have a very solid reputation for developmental and reproductive toxicology (DART) studies at WIL. Lyon strengthens our position as the market leader with many clients describing the site as the “go-to” lab in Europe for pharma DART studies. We’ll
also leverage Lyon’s ample strengths in safety pharmacology and infusion technologies.
In which fields will WIL Research expand in Europe?
! Spaight: We’ve built a broad array of capabilities across our sites that serve not only the needs of our European customers, but also those worldwide. As we move forward, we’ll focus on developing or acquiring innovative new platforms that bring value to our clients in the drug discovery and safety assessment markets. D
WIL Research services at its different sites in Europe, Japan and the US Site
A WIL Research – Ohio (US)
General toxicology Developmental and reproductive toxicology Safety pharmacology Neurotoxicology Juvenile toxicology ADME/DMPK services Formulations Analytical chemistry & Bioanalytical chemistry Pathology Infusion toxicology/Inhalation toxicology Large molecule bioanalysis
A WIL Research – Illinois (US)
Genetic toxicology Clinical and nonclinical immunoassay services – Ligand binding – Immunogenicity – Neutralizing antibody assays – Biomarkers – Potency
A WIL Research – North Carolina (US)
Pathology services Histology/Histopathology Immunohistochemistry Stereology
A WIL Research - Japan
In partnership with Three S Japan, pharmaceutical and agrochemical support for safety assessment services in the Japanese market.
A WIL Research – The Netherlands
General toxicology Developmental and reproductive toxicology Genetic and in-vitro toxicology Environmental toxicology and environmental fate Metabolism Regulatory support for registration of compounds Small and large molecule chemistry support Pharmacokinetics and metabolism Safety pharmacology Pathology Physical-chemical properties
A WIL Research – France
General toxicology Safety pharmacology Development and reproductive toxicology Juvenile toxicology Infusion toxicology
Join the European Biotechnology Network! The European Biotechnology Network is dedicated to facilitating co-operation between professionals in biotechnology and the life sciences all over Europe. This non-profit organisation brings research groups, universities, SMEs, large companies and indeed all actors in biotechnology together to build and deliver partnerships. Do you want to know more about the advantages of a (free) membership? Just have a look at our website: www.european-biotechnology.net
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