ABF Pharmaceutical Services GmbH

Transcription

1 ABF Pharmaceutical Services GmbH

2 Facts and Figures GBA is a European laboratory group with an annual turnover of +40 M. Founded in 1989, Hamburg Our business covers Pharma, Environmental, Foodstuff, Consumer Goods analysis and services 11 sites in Germany and 2 sites in Austria approx. 480 employees Hameln Herten Gelsenkirchen Saarbrücken Pinneberg Hamburg Hildesheim Freiberg Gräfelfing Neu-Ulm Martinsried Wien Environment Foodstuff Pharma Consumer Goods Leoben ABF Pharmaceutical Services GmbH 2

3 GBA Pharma Organisation Headquarter GBA Holding GmbH (Hamburg) GBA Pharma Division GBA Pharma GmbH Sites Martinsried, Gräfelfing, Ulm ABF Pharmaceutical Services GmbH Site Vienna Pharmacelsus GmbH Site Saarbrücken ABF Pharmaceutical Services GmbH 3

4 Sites of GBA PHARMA Vienna CTSM Martinsried Pharmaceutical Testing GMP Gräfelfing Pharmaceutical Testing GMP Neu-Ulm Pharmaceutical Testing GMP Saarbrücken Preclinical Research & GLP / GCP Bioanalysis Specialties: IMP packaging & labelling IMP storage & distribution QP Services Quality & regulatory support PBMC network management Clinical Trial supply management Specialties: Bioanalytical services, Method development and validation Elemental impurities Q3D Release and stability testing Stability management Elucidation & identification of impurities Specialties: Dissolution, method development & validation Amino acid analyzers Special lab for highly potent compounds Isolation & identification of impurities Extractables & Leachables Regulatory affairs Specialties: Method development & validation Microbiology Small molecules in biotech products Antibiotics Testing of packaging materials Herbal medicinal products Specialties: In vitro / in vivo PK/PD studies ADME(T) GCP/GLP bioanalysis & biomarkers (ELISA, Luminex, LC-MS) ABF Pharmaceutical Services GmbH 4

5 Your Challenges Require Smart Solutions In vitro and in vivo testing Bioanalysis of drugs, metabolites & biomarkers Non-GLP / GLP IMP handling, storage, global distribution & QP services Central lab services PBMC network access & management Pre-Clinic GMP Testing Clinical Trial Supply Regulatory Raw/starting materials & finished products Method development & validation Release & stability testing Microbiology GMP / GLP / GCP Market authorization ABF Pharmaceutical Services GmbH 5

6 We Support You Throughout the Entire Lifecycle API Research Preclinical Studies Clinical Phase I-IV Marketing Authorization Application FMP Production & Batch Release Product Lifecycle Management ABF Pharmaceutical Services GmbH 6

7 Capabilities IMP Handling IMP handling: Active trials: +120 Countries: +40 Cities: +200 Geographic Network: Vienna drug depot is Brexit protected! Global Shipping Further drug depots in North America, Eastern Europe, Middle East Region, Australia and Asia Specialities: Infrastructure & experience to handle biologicals / personalised Medicine Licensed to handle controlled drugs ABF Pharmaceutical Services GmbH 7

8 Global Distribution Management Global organization of import & export Just in Time shipment: planning, tracking & reporting Handling customs clearance Extensive expertise in controlled temperature supply chain management Network of qualified supplier (e.g. couriers & drug depots) Experience with the full integration of digital order management systems via IxRS ABF Pharmaceutical Services GmbH 8

9 IMP Handling Primary packaging, Outer Packaging, Blinding and comparator sourcing Customized labels: Country specific text design, translation & GMP printing of labels Single panel labels, Multi language labels, Booklet, Tear off labels, Wrap labels Authorized & controlled production facilities for primary & secondary packaging Labelling, relabelling & packaging according to GMP guidelines Labelling at ambient temperature, +2 C(35.6 F) to +8 C(46.4 F) and dry ice Recalls, Blinding, Randomization, Emergency envelopes Return for drug accountability and destruction (including certificate) ABF Pharmaceutical Services GmbH 9

10 IMP Storage & Conditions License for controlled drugs (narcotics) & BSL-2 requirements Quality check - Customs handling - Shipments Warehouses monitored 24 / 7 / 365 with emergency back-up GMP compliant +15(59 F) C (77 F) temperature / humidity controlled warehouse GMP compliant +2(35.6 F) - +8 C(46.4 F) temperature /humidity controlled warehouse Special GMP compliant temperature storage (-20 C = -4 F) and -80 C = -112 F) ABF Pharmaceutical Services GmbH 10

11 QP Qualified Person Services Austrian drug law does not allow external/freelancer QPs! Full time QP s (n = 3) ensure full operational overview in daily business Legal/Regulatory advice on local requirements Clinical Trial Consulting Services incl. preparation/revision batch records and SOPs CMO Audits: Drug substance & Drug Product License for IMP import & export incl. QP declaration & QP release Batch release (QP-Release) with CoC is issued by QP ABF Pharmaceutical Services GmbH 11

12 Drug & MedTech Experience Human Medicinal Products Veterinary Medicinal Products Small Molecules Biologicals Herbal Drugs and Herbal Medicinal Products Homeopathic Medicinal Products Non-active Medical Devices Cell Based Therapy / Advanced Therapy Medicinal Products ABF Pharmaceutical Services GmbH 12

13 Pharmaceutical Services Central Laboratory Supply Design of study-specific kits Compilation of lab manuals barcoded label print + pre-labeling Design of requisition forms Automated material (re-)supply World-wide sample pick-up and sample shipment (all temp. ranges) Sample storage (all temp. ranges) ABF Pharmaceutical Services GmbH 13

14 CENTRAL LABORATORY Establishment and validation of new assays with state-of-the-art equipment according to FDA, EMEA and ICH-guidelines Performance of studies compliant with FDA, EMEA, ICH, GLP- and GCLP-guidelines Safety profiles: hematology, coagulation, clinical chemistry and urinanalysis Pharmacodynamic parameters: hormones, biomarkers, metabolic parameters, coagulation factors, antigens Special safety studies, e.g. GFR/ERFP assessment through iohexol and paraaminohippuric acid PK Customized alert-lists for the notification of study centres in case of critical lab results Reporting via electronic data transfer, fax and mail and Web-access for test results Upload of test results in ecrfs ABF Pharmaceutical Services GmbH 14

15 Challenges of PBMC Opportunity: Peripheral Blood Mononuclear Cell (PBMC) are an essential part of the immune system It enables to evaluate immune modulation & the immunogenicity of drugs Requirements: Quality & Speediness in sampling and post processing (=> viability & selectivity) Majority of clinical sites is not able to handle technical & logistical challenges of PBMC preparations Solution: We provide dedicated labs in close proximity to your selected clinical sites ABF Pharmaceutical Services GmbH 15

16 ABF - PBMC NETWORK More than 40 audited and qualified labs for isolation in 15 countries Qualification and audit of new labs Training of labs Lab manual Requisition form Lab material (kits) supply to site and lab Blood sample logistics Equipment purchase Temperature monitoring ABF Pharmaceutical Services GmbH 16