LAB EXPERTS AT YOUR SIDE Over twenty years of experience

Transcription

1 LAB EXPERTS AT YOUR SIDE Over twenty years of experience

2 About us SYNLAB Pharma offers a broad range of laboratory services to the biotechnology, pharmaceutical and cosmetic industries as well as to manufacturers of medical devices, novel foods and crop protecting agents. Our clients take advantage of our large spectrum of analytical methods for drug development and production including our global logistical capabilities; always working in accordance with the highest standards such as DIN/EN ISO/IEC 17025/15189, GMP, GLP, GCLP or GCP. The SYNLAB Group is the leading laboratory services provider in Europe. SYNLAB offers a full range of innovative and reliable medical diagnostics for patients, practising doctors, clinics and the pharmaceutical industry. SYNLAB operates in more than 35 countries across four continents and holds leading positions in most markets. Over 20,000 employees contribute every day to the Group s success across different geographies. SYNLAB carries out about 450 million laboratory tests per year, achieving sales revenue of circa 2 billion. Europe s largest laboratory service provider. 2

3 SYNLAB Pharma SYNLAB Pharma supports the whole life cycle from research and development, through preclinical and clinical studies to release and manufacturing of the final drug product. Our portfolio at SYNLAB Pharma includes: Central clinical laboratory services Bio-analytical services Biomarker testing Personalised medicine concepts Sample logistics Long-term sample storage services Stability and release testing Production monitoring and hygiene testing Take advantage of our extensive experience gained from supporting more than 3,000 clinical trials and projects. Over twenty years of analytical expertise. PHARMA BIOTECH MED DEVICES NOVEL FOODS COSMETICS R & D small & large molecules GLP/GCP central lab services biocompatibility biomarkers PD method development PK/immunogenicity raw material product release GMP surface/water/air microbiology residuals/impurities leachables and extractables stability studies manufacturing bioanalytics hygiene Successful Drug Develoment 3

4 What we offer Pharmaceuticals SYNLAB Pharma provides a wide range of analytical services supporting our customers from drug discovery through preclinical and clinical studies to release and manufacturing of the final drug product. We have over 20 years of experience in supporting the pharmaceutical industry, from the measurement of single assays to the execution of complex and demanding projects across the entire life cycle of a pharmaceutical product. Biopharmaceuticals SYNLAB Pharma develops and implements strategies for the analysis of innovative products, bio similars and biobetters. Only to name some areas of expertise: PK and PD, biomarkers and immunogenicity including assay development, optimization and validation. In addition, the drug production process is supported by our broad experience in running bioassays for release and stability testing. Release & Stability Another core service of SYNLAB Pharma is stability studies in accordance with ICH Q1A(R2), including consultancy, planning, storage and analysis. SYNLAB Pharma supports all stages of successful drug product registration: Long-term, intermediate and accelerated stability; ongoing and follow-up stability studies, stress testing (including photo-stability testing), and compatibility studies. 4

5 Medical Devices The development of medical devices requires specialized lab testing in order to cope with the increasing regulatory requirements. SYNLAB Pharma has the expertise in running biocompatibility testing (ISO 10993), leachable & extractable studies, toxicological and microbiological tests of medical devices for biological evaluation in development, registration and production. Novel Foods SYNLAB Pharma is the GLP, GMP and GCP lab expert during R&D and manufacturing of novel foods in accordance with the European guideline (1223/2009). Analytical services include: bioanalytical testing, hygiene, microbiology, toxicology and clinical trial services. Cosmetics SYNLAB Pharma supports all stages of the production process of cosmetics. We offer consultancy for analytics and quality control, physico-chemical methods, stability studies under defined climate conditions, microbiological and in-use stability tests. Quality controls are performed according to EP, USP or customer requirements. 5

6 Clinical Trial Services Early & Late phase SYNLAB Pharma provides real-time lab testing (24/7) of safety panels for several phase I units. In addition, PK/PD testing and a broad spectrum of biomarkers in various matrices (serum, plasma, urine, sputum, stool or CSF) is available. For phase II and phase III studies central routine lab testing for the evaluation of safety and patient in/exclusion criteria is provided as well as advanced analytical services for efficacy evaluation. Our portfolio includes: PK/PD testing Immunogenicity testing Wide range of established biomarkers Genetic testing (e.g. HLA, genotyping, mutation detection) Histopathology and cytology Additional services SYNLAB Pharma has implemented over the last 20+ years various customised services and solutions in order to cope with more and more demanding study protocols. Our clients benefit from this experience and a vast portfolio including: PBMC preparation Paediatric sample collection materials and adapted analytical solutions to reduce blood volumes to a minimum Visit-specific kit building Customized data management Secure online access to lab data Extended sample storage incl. storage in liquid nitrogen Global strengths SYNLAB Pharma has experience in supporting global trials for 20 years. During that period reliable worldwide shipping logistics have been established in cooperation with premium couriers. All lab data are pooled in one single database located in Germany and the lab reports show an identical layout worldwide including customised flagging and global reference ranges. All trials are overseen by our global Project Management teams and global quality assurance secures valid results. 6

7 Central Lab Services SYNLAB Pharma pairs the technology and the advantage of economies-ofscale of our reference laboratory with the flexibility and responsiveness of our clinical trials division to deliver the flexibility and high quality sponsors deserve. Global reach is available via our laboratory network with facilities in Europe, North and South America, South Africa, Near and Middle East, Australia, Asia and India. Periodic audits and cross-validations ensure data comparability through test correlations and evaluation of data accuracy and precision. Our dedicated project teams supervise and coordinate all global activities. This results in highly reliable shipping logistics and clean electronic data transfers. 7

8 Analytical services SYNLAB Pharma offers PK testing using HPLC-MS/MS and the analysis of a broad range of Biomarkers in various matrices (serum, plasma, urine, sputum, CSF or stool). Another main area focuses on analysing biopharma ceuticals (innovator products, biosimilars, and biobetters) in preclinical, clinical and post marketing studies as well as during the manufacturing process. In addition to this, SYNLAB Pharma serves stability and release studies, as well as comparability studies. Method Development Customized method development (identity, content, purity, and robustness) GMP- method validation and transfer for assay, purity & stability testing according to EMA/FDA guidelines Biochemical and functional cell based assays Small Molecules Quantification of drugs and metabolites in bodily fluids and tissues Toxicokinetic and pharmacokinetic analysis of samples from preclinical and clinical trials Analytical support in DDI and BE/BA studies Metabolite profiling and metabolite identification in studies using cold or 14C labelled drugs Analysis of biomarkers Large Molecules Quantification of biopharmaceuticals in bodily matrices Immunogenicity strategy including ADA and neutralising assays Analysis of biomarkers Bioassays for stability and release testing 8

9 Special Analytics Structure elucidation of unknown impurities & degradation products Determination of mutagenic impurities according to ICH M7 Supply and qualification of non-compendial reference standards for impurities for quality control (including GMP-CoA) Storage, packaging and shipping of reference Standards Preparative isolation and characterization of impurities GMP Analytics & Quality Control Testing Release testing according to Pharmacopeia (EP/USP) Testing of primary packaging materials including leachable & extractable testing Handling of controlled substances Stability studies Heavy metal determination according to ICH Q3D and USP Particle size distribution Stability Studies in accordance with ICH Q1A(R2) Long-term, intermediate and accelerated stability studies (25 C / 60 % RH; 30 C / 65 % RH; 40 C / 75 % RH) Ongoing and follow-up stability studies Inuse stability studies Stress testing (including photostability testing) Compatibility studies 9

10 Global Quality Management SYNLAB Pharma offers a unique range of laboratory services always working in accordance with the highest available standards such as DIN/EN ISO/ IEC 17025/15189, GMP, GLP, GCLP or GCP. Quality implementation In addition to our own comprehensive quality procedures, SYNLAB Pharma undergoes periodic audits from customers as well as from national and international regulatory authorities including DAkkS, FDA, Swissmedic and UKAS. This ensures an ongoing review of all methods, procedures and results with continuous improvement of all established processes. International quality system SYNLAB Pharma guarantees that all services rendered are provided by continuously trained professionals who know the importance of each individual sample received. Periodic audits of all laboratory facilities are performed by our QA team. Rigorous cross-validation ensures comparability of global lab results. Highest IT standards Our IT platforms enable the dispatch of lab reports all over the world to display identical layout, content and flagging criteria. Secure online access is standard. 10

11 Analytical Expertise GCP, GCLP, GLP & GMP for Pharma Biotech Medical Devices Novel Foods Cosmetics Crop Protection Agents Clinical Trial Services 24/7 lab service for Phase I trials Safety panels and hematology Full analytical spectrum Genetics and PCR Microbiology and bacteriology Histopathology and cytology Study-specific Services Visit-specific kit building Extended sample storage Worldwide shipping logistics Customized data management Secure online access to data Bio-Analytical Services PK/PD drug assays Structure elucidation Identification of metabolites Small/large molecules Bioassays Cell based assays Immunogenicity Customized Analytical Services Biomarker development PBMC cell separation Assay development Method validation Pharmacogenomics Rapid processing of larger batches GMP Analytical Services for Drug Products and Drug Substances Release testing according to Pharmacopeia (EP/USP) GMP storage Stability testing according to ICH guidelines Microbiological testing / bio burden Leachable & extractable testing Heavy metal determination to ICH Q3D Method development and validation for assay and impurity testing Handling of controlled substances Manufacturing Support Service Sterility testing Clean air/water analysis Hygiene & bacteriology Quality monitoring Global Strengths One single database Identical lab reports worldwide Customized flagging Global quality assurance One key contact eases communication 11

12 SYNLAB Analytics & Services Germany GmbH Gubener Straße Augsburg No liability for errors, mistakes and incorrect price data. Changes reserved. All texts, images and contents are under copyright of SYNLAB Analytics & Services Germany GmbH. SAS_IMA_SPI_INT_EN_122018