IBG-FARMA

DRUG ANALYSIS AND CONTROL LABORATORY

Drug development requires preclinical studies prior to IND application which should be performed in GLP certified laboratories. There is no GLP certified preclinical testing facility in Turkey, which constitutes a significant barrier for new molecular entity development. IBG has established Drug Analysis and Control Laboratories which are in compliance with GLP regulations and Quality Management System.

Good Laboratory Practice (GLP) in an internationally recognized indicator of technical competence in pre-clinical studies. By providing official recognition of the competence of laboratories, it ensures a convenient method for identifying and selecting reliable test and analysis services for institutions in need of preclinical work for their molecules.

In order to prove the compliance with OECD GLP regulations, İBG Drug Analysis and Control Laboratories have applied to TURKAK for an inspection, which is planned to be carried out in November 2019.

Activities listed below are planned to be carried out in compliance with GLP regulations in Characterization, Preclinical and Microbiology laboratories established under the Drug analysis and Control Laboratories.

Click here for contact procedure with sponsors.

Click here for the procedure including test material accepting criteria.

HUMAN RESOURCE AND EXPERIENCES

Soner GÜNDEMİR, PhD, MBA (Pharmacologist)
Received Bachelor’s degree from the Middle East Technical University, Department of Molecular Biology and Genetics in 2005. Completed PhD studies on Pharmacology at the University of Rochester School of Medicine in 2010. Worked on novel drug development in different laboratories in the USA and the UK during his postdoctoral studies,. Also received an MBA degree from Sabancı University. Expericed in pharmaceutical R&D, especially in biotechnological R&D.

Ayşegül DEMİRTAŞ, Pharm., M.S.  (Pharmacologist)
Received her Pharmacist degree from Hacettepe University and Master’s degree on pharmacology from the same University. Worked at the Turkish Medicines and Medical Devices Agency (TMMDA) for 13 years in different roles: 7 years as a quality control analyst, 5 years as a quality assurance manager and 1 year as a for quality control lab manager. Certified expert on several Quality Management Systems (GLP, ISO 9001, ISO 17025, OHSAS, etc.). Head of Microbiology Group for the Turkish Pharmacopoeia. BET group specialist for the European Pharmacopeia. Currently working as Quality Assurance Manager at Izmir Biomedicine & Genome Center.

Tuba Karaman, Pharm.
Received her Pharmacist degree from Ankara University. Worked as manufacturing specialist at İlko Pharma and as pharmacovigilance specialist at the Grand Medical Group. Currently working as a Quality Assurance Specialist at Izmir Biomedicine & Genome Center.

Irmak Tunakan
Received her Bachelor’s Degree on Mathematics from Ege University. Currently working as a Specialist for Test Material Acceptance and Archives at Izmir Biomedicine & Genome Center.

Preclinical Studies

EQUIPMENT INFRASTRUCTURE

Our preclinical laboratories, serving on more than 800 m2 area, have infrastructure and equipment that meets OECD GLP criteria. There are several speciality areas in our facility, including animal housing rooms for mouse, rat, guinea pig and rabbit; rooms for procedure and necropsy.

Equipments: IVC (individually ventilated cages), metabolic cage systems, imaging systems, flow cytometry and many equipments necessary for in vivo and in vitro tests.

METHODOLOGY

PHARMACOLOGY EFFICACY & POTENCY STUDIES

  • In vitro Potency Tests
  • In vivo Potency Tests
  • Pharmacodynamic Tests (in progress)
  • Pharmacokinetic Tests (in progress)

TOXICOLOGY TESTS

  • Acute Toxicity
  • Systemic Injection Test
  • Abnormal Toxicity Test
  • Repeated Dose Toxicity

HUMAN RESOURCES AND EXPERIENCES

Umur KELEŞ, DVM, M.S.
Received his Bachelor’s Degree in Veterinary Medicine Ankara University and served in obstetrics and gyneacology clinic. Graduated from Bilkent University Molecular Biology and Genetics Department, MSc program. Currently serving as the Head of Preclinical Laboratory and Head of Vivarium at İzmir Biomedicine & Genome Center.

Kerem ESMEN, DVM
Received his bachelor degree in Ankara University Veterinery Medicine. Worked as Responsible of Pharmacovigilancein company PHARMAQ. Currently working as veterinarian in İzmir Biomedicine and Genome Center.

Alkan GÖKÇEOĞLU, DVM
Received his bachelors degree in Ondokuz Mayıs University Veterinary Medicine. Worked as veterinarian in private Foks veterinary clinic. Also worked as consultant in private company optima nutrition. Currently working as veterinarian in İzmir Biomedicine and Genome Center.

Biopharmaceutical Characterization

EQUIPMENT INFRASTRUCTURE

Our Characterization Laboratory is equipped with state-of-the-art instruments and offers a wide range of analyses including structural characterization, physicochemical properties, purity/impurity tests, which are performed in compliance with ICH quidelines.
Characterization Laboratory owns UPLC-QTOF MS, UV-Vis Spectrophotometer, Gel Electrophoresis, Isoelectric Focusing and Osmometer instruments.

METHODOLOGY

STRUCTURAL CHARACTERIZATION ANALYSES

  • Peptide Mapping (LC/LC-MS)
  • Amino Acid Sequence, Composition (LC/LC-MS)
  • Terminal Amino Acid Sequence (LC-MS)
  • Glycan Analysis (LC-MS)
  • Disulfide Bond, Sulfhydryl Group Analysis (LC-MS/Spectrophotometer)

PHYSICOCHEMICAL PROPERTIES

  • Molecular Weight/Size (LC-MS/Gel Electrophoresis)
  • Isoform Pattern (Gel Electrophoresis)
  • Extinction Coefficient (LC/Spectrophotometer)
  • Electrophoretic Pattern (Gel Electrophoresis)
  • Chromatographic Pattern (LC)

PURITY/ IMPURITY ANALYSES

  • Process-Related Impurities (LC /ELISA/PCR)
  • Product-Related Impurities (LC/LC-MS/Gel Electrophoresis)

GENERAL PROPERTIES

  • Amount (LC/Spectrophotometer)
  • pH
  • Osmolality
  • Appearance
  • Volume

HUMAN RESOURCES AND EXPERIENCES

Melda Zeynep GÜRAY, PhD
Received Bachelor’s degree in biochemistry from Ege University; Master’s degree in Biotechnology and PhD degree in Chemistry from Izmir Institute of Technology. Worked as research assistant at Izmir Institute of Technology for 6 years. Currently working at Izmir Biomedicine & Genome Center as the Head of Characterization Laboratory.

Idil TİLMENSAĞIR
Received Bachelor’s Degree in Chemistry from Izmir Institute of Technology with a minor in Molecular Biology and Genetics. Currently working at the Izmir Biomedicine & Genome Center as a chemist in Characterization Laboratory.

Microbiology and Sterility

EQUIPMENT INFRASTRUCTURE

The following tests are planned to be conducted in the Microbiology Lab in accordance with European Pharmacopoeia and American Pharmacopoeia.

All the necessary equipment are available in our laboratory for the specified tests.

METHODOLOGY

MICROBIAL LIMIT TESTS (MLT)

  • Pour-Plate Method (in progress)
  • Membrane Filtration Method (in progress)

BACTERIAL ENDOTOXIN TESTS

  • Gel-clot Method
  • Kinetic-turbidimetric Method (in progress)

STERILITY TEST

  • Direct Method (in progress)
  • Membrane Filtration Method (in progress)

MYCOPLASMA CONTROL TEST

  • Culture Method (in progress)
  • Indicator Cell Culture Method (in progress)
  • PCR Method (in progress)

HUMAN RESOURCES AND EXPERIENCES

Selin YEŞİL, M.S.
Received Bachelor’s degree on Molecular Biology and Genetics from Ege Universtiy and Master's degree at Istanbul University Forensic Medicine Institute. Worked at Radix Izmir Analysis Laboratory as the Head of Molecular Biology and Genetics Laboratory for 3 years. Worked as the Head of the Microbiology Laboratory of Akre Water Analysis Laboratory for 1 year. Currently working as the Head of Microbiology Laboratory at İzmir Biomedicine & Genome Center.

Personnel

AYŞEGÜL DEMİRTAŞ Quality Assurance Unit Manager  aysegul.demirtas@ibg.edu.tr
+90 232 299 41 00 (2401)
02322994144

AYÇA ZEYBEK KUYUCU Researcher  ayca.zeybekkuyucu@ibg.edu.tr


DOĞU SAYILI Molecular Cell Biologist  dogu.sayili@ibg.edu.tr


MELDA ZEYNEP GÜRAY Biopharmaceutical Characterization Lab. Principal  melda.guray@ibg.edu.tr
+90 232 299 41 00 (2901)

İDIL TİLMENSAĞIR Drug Analysis and Control Technician  idil.tilmensagir@ibg.edu.tr


IRMAK TUNAKAN Sample Admission and Archive Personnel  irmak.tunakan@ibg.edu.tr
+90 232 299 41 00 (3801)

OLCAY MERT Senior Bioprocess Engineer  olcay.mert@ibg.edu.tr


RIDVAN ÖRKÜT Senior Bioprocess Engineer  ridvan.orkut@ibg.edu.tr
+90 232 299 41 00 (4001)

SELIN YEŞİL Microbiology Specialist  selin.yesil@ibg.edu.tr


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