Pre-GMP Facility at ANA FUTURA Preliminary advanced equipment

Slides:



Advertisements
Similar presentations
Setting up a Molecular Lab in a Developing Country
Advertisements

MICS4 Survey Design Workshop Multiple Indicator Cluster Surveys Survey Design Workshop MICS4 Technical Assistance.
Supplementary Training modules on Good Manufacturing Practices
Cell Culture Facilities and Equipment Presenter: Dr. R. Rahbarghazi.
Page 1 Private & Confidential NextPharma Technologies Holding Limited Sterile Product Development Centre (SPDC) At Braine-lAlleud, Belgium.
Dock to Stock at Skyline Biotech A brief Outline of how we make our product at Skyline Biotech.
Course KLARA bar codes In English
The Early Phase (0-I-II) Clinical Drug Research Unit of Maastricht University Medical Center (MUMC) prof dr L. Van Bortel Drug Research Unit Maastricht.
Preparing an Overnight Culture of Escherichia coli
Focus on STEM Education Sierra College CACT is focused on STEM education & product development Need a supply of future STEM workers Students are not prepared.
Confocal Laser Microscopy at the MHH. Laser Microscopy Facility Zentrale Forschungseinrichtung Lasermikroskopie Location: Building I4, Level 01 Contact:
This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya). You can freely download, adapt, and distribute this.
Center for Biologics Evaluation and Research Applying Regulatory Science to Advance Development of Innovative, Safe and Effective Biologic Products Carolyn.
Center for Biologics Evaluation and Research FDA Overview Site Visit Carolyn A. Wilson, Ph.D. Associate Director for Research.
Agricultural Faculty Bd. of AGU - Concept Drawings Handong graduate school.
Biopharmaceutical Production Biopharmaceutical development and GMP manufacturing Professionally sound Reliable Innovative Open Respectful.
Clinical Research Center at a Glance Lynda Lane MS Administrative Director.
School of Medicine Shared Resource Facilities The School of Medicine provides direct support and oversight to 21 SOM shared resource facilities. Their.
Special School of Athens School Presentation/ Activities.
23 Au. Strategies for Developing Air Freight Transportation & Logistics System & Logistics Suvarnabhumi CHANCHAI SINGTOROJ Managing Director,
Biotechnology Program At Ivy Tech Community College, Lafayette Krishna K Mishra, Program Chair.
Clinical Laboratory equipment. Clinical laboratory is equipped with various biomedical instruments, equipments, materials and reagents for performing.
Laboratory Hardware Part 1 Bioscience, Equipment Unit 6 Centrifuge, Water Baths, and Incubators 8/29/
Chris Qualls Director, Engineering & Technology Boehringer-Ingelheim: Insight into Advanced Manufacturing.
Biosafety Recommendations for Laboratory Testing for TB
GMP on blood/plasma collection establishments Group 2.
生命科學院 科技共同空間 TechComm Technology Commons. TechComm: Organization TechComm (TC) is supervised directly by TC Committee, which is constituted by the Dean.
Raw Materials Disinfecting, autoclaving and discarding of waste material Cleaning of glassware, vessels and other small equipment/ material Chemical dispensary.
LIB site visit January 24, 2002 Jay E. Slater, MD Laboratory of Immunobiochemistry FDA/CBER/OVRR/DBPAP.
THE BIOTECHNOLOGY WORKPLACE. OVERVIEW Biotechnology workplaces Laboratories.
ISCT Lab Practices Committee Who are we & What do we do?
What do we need GMP compliant facility (R1 billion 2008) Flow, segregation, containment, environmental, statutory Modern technologies for raw material,
Hiring a Nurse Researcher/Scientist Nursing Research Field Advisory Committee (NRFAC) January 2015.
Tools and Procedures 1-4 Most scientists use the metric system when collecting data and performing experiments.
Regulatory Issues in Laboratory Management
Facilities for a Quality Child Development Program Child Services II.
Funded by the National Institutes of Health Science Education Partnership Award and the Howard Hughes Medical Institute.
Abstract To accomplish the legal national and international requirements for the elaboration of elements for advanced therapies, the Maimonides University.
Budget Presentation: Tuberculosis Control in Malawi Round 11 proposal to the Global Fund to Fight AIDS, Tuberculosis and Malaria Babatunde Adewoyin --
DIA ERS SIAC IND CMC eCTD Submissions Part II – IND to NDA
INOLINK The Leading French Science Park Is happy to welcome
Mission SUPPORT BASIC RESEARCH TO DEVELOP DRUGS, DIAGNOSTICS, AND VACCINES FOR EMERGING AND REEMERGING INFECTIONS AND BIODEFENSE. The Duke RBL supports.
New Approaches to Metabolomics Research
Ensuring Successful Technology Transfer for Clinical Manufacture
Author: Nurul Azyyati Sabri
Biomedicum – Research without boundaries
UTMB Laboratory Pre-analytical Time Improvement
Undergraduate Laboratories: Course Check-In List
VxP Pharma The Pharmaceutical Services Company
Multiplication table. x
Sponsors Fact Sheet For more information please
What the zebrafish core facility can offer you:
Synthetic Labs - Check In List
Biotechnology Objectives: At the end of this lecture we will be able to identify and describe the uses of biotechnology in society.
Nicholas P. Ambulos, PhD Director, CIBR October 24, 2017
Laboratory facilities
Eucaryotic Cell Bank Technology Transfer to the ‘BioMoBiL’ Centre 29 / 10 / 2004 Konrad Kleszczyński Jolanta Grzenkowicz – Wydra.
Specimen Processing and Analytical Nexus
Overview of the PAT Implementation Process Materials Developed by The IRIS Center at the University of Maryland.
The Department of Neurobiology, Care Sciences and Society (NVS)
The Department of Neurobiology, Care Sciences and Society (NVS)
PLASMID ISOLATION AND ANALYSIS Part I Overnight Culture Suspension
A new approach to delivery
Protein Expression and Proteomics (PEP) Core Update
General Chemistry Lab Class
Continuing challenges regarding previous “findings” :
MD Tech Council – Doing Biz w/ NIH
Laboratory Equipments
What the zebrafish core facility can offer you:
Presentation transcript:

Pre-GMP Facility at ANA FUTURA Preliminary advanced equipment A new facility for safe translation of ATMPs from the lab to the clinic What can you do at the Pre-GMP facility? HQ plasmid production and purification Viral vector production and purification Cell expansion and formulation in automated, closed systems Gene transfer by flow electroporation in closed system Isolation and purification of extracellular vehicles What would you like to do? Purposes of the Pre-GMP facility Make research projects ready for transition to GMP production Develop and validate SOPs Test new equipment Education and staff training At the ANA FUTURA building at KI Campus Flemingsberg 10.000 m2 of newly rebuilt laboratory and office space with >300 world leading scientists, clinicians, and teachers Access to advanced facilities for: Bio Safety Level-3 laboratory for developing new viral vector systems Complete full service FACS facility for cells sorting and analysis Mass spectrometry for proteomics and metabolomics Confocal microscopy 5 fully equipped rooms for: cell expansion, vector and plasmid production and purification, multiple projects development Office space and archives Design 500 m2 5 clean rooms 3 locked offices Storage and – 80oC freezers In each clean room Class II LAF benches CO2 incubators Table top and high capacity centrifuges Bright field microscopes 2 Fridge/Freezer ANA FUTURA building Campus Flemingsberg Pre- GMP Facility Preliminary advanced equipment HQ plasmid production Fermentors TFF/ÄKTA Viral vector production Transduction/electroporation Virus/particle quantificantion TFF/ÄKTA (purification) Quantum (packaging cell culture) Cell culture and expansion Xuri Quantum Milteniy Prodigy Location: Karolinska Institutet Campus Flemingsberg ANA Futura Floor 7 Alfred Nobels Alle 8 141 52 Huddinge Contact Information: Anna Pasetto, PhD Managing Director Pre-GMP facility 08-52483857; 0702689758 anna.pasetto@ki.se