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Pharmaceutical Freeze Drying Technology
13 June - 14 June 2018
Pharmaceutical Freeze Drying Technology

** MANAGER'S SPECIAL RATE ** - REGISTER TODAY FOR ONLY £999! **

  • Check out our exclusive content in the download centredownload centre, from the breakdown of attendees, full attendee list and speaker interviews from Janssen, NIBSC-MHRA and Genzyme Ireland.

Although an old process, Pharmaceutical Freeze Drying is ever evolving with new trends and approaches being used for pharmaceutical formulation. The 6th Annual Pharmaceutical Freeze Drying Technology conference will cover the most recent advances in Freeze drying technology and discuss the latest ideas in the industry. Join us in June, to explore new approaches to prediction and analysis, alternative freeze drying technologies and overcome the challenges of freeze drying technology.
 

 

FEATURED SPEAKERS

Daryl Williams

Daryl Williams

Director of Development, Chem. Eng. Discovery, Imperial College London
Miguela Vieru

Miguela Vieru

Research & Development, PDMS - Parenterals & Liquids, Janssen Pharmaceutica NV
Paul Matejtschuk

Paul Matejtschuk

Principal Scientist, NIBSC
Sune Klint  Andersen

Sune Klint Andersen

Principal Scientist Spray Drying , Janssen Pharmaceutica NV

Daryl Williams

Director of Development, Chem. Eng. Discovery, Imperial College London
Daryl Williams

Dikshitkumar Khamar

Senior Scientist, Genzyme Ireland Ltd
Dikshitkumar Khamar

Eric Munson

Professor, Pharmaceutical Sciences, University of Kentucky
Eric Munson

Erwan Bourles

Expert Scientist, Head Filling Drying Device, GSK
Erwan Bourles

Geoff Smith

Professor of Pharmaceutical Process Analytical Technology, DeMontford University
Geoff Smith

Kevin Ward

Director of R&D , BioPharma Technology
Kevin Ward

Maryam Hussain

Research Assistant/ PhD Student, University Of Strathclyde
Maryam Hussain

Miguela Vieru

Research & Development, PDMS - Parenterals & Liquids, Janssen Pharmaceutica NV
Miguela Vieru

Mire Zloh

Emeritus Professor of Medicinal Chemistry, University of Hertfordshire
Mire  Zloh

Patrick Garidel

Process Sciences Department, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim
Patrick  Garidel

Paul Matejtschuk

Principal Scientist, NIBSC
Paul Matejtschuk

Robert Forbes

Professor of Clinical Pharmaceutics, University Of Central Lancashire
Robert Forbes

Sune Klint Andersen

Principal Scientist Spray Drying , Janssen Pharmaceutica NV
Sune Klint  Andersen

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Opening Remarks and Introductions

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9:10

Session 1: Principles of formulation and freeze

Paul Matejtschuk

Paul Matejtschuk, Principal Scientist, NIBSC

  • Basic principles of freeze drying
  • What makes a good formulation?
  • Designing a freeze drying cycle
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    9:50

    Session 2: Principles of DoE in pharmaceutics

    Robert Forbes

    Robert Forbes, Professor of Clinical Pharmaceutics, University Of Central Lancashire

  • What is Design of Experiments and how can it be applied in formulation?
  • DoE in formulation – screening and optimisation
  • Impact of DoE over classical approaches
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    10:30

    Morning Coffee

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    11:00

    Session 3: Examples of formulation optimisation by

    Robert Forbes

    Robert Forbes, Professor of Clinical Pharmaceutics, University Of Central Lancashire

  • Example of One Factor At Time formulation
  • Example of DoE in Vaccine formulation (published study)
  • Cost effective use of DoE
  • clock

    11:40

    Session 4: From trial to scale-up

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

  • Principles of scale up in freeze drying
  • Hardware considerations
  • Examples
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    12:20

    Closing Remarks

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    13:30

    Registration & Coffee

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    14:00

    Opening Remarks and Introductions

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    14:10

    Session 1: Overview of Critical Quality Attributes (CQAs) of Lyophilised Products and Analytical Methods

  • What are the typical CQAs?
  • Analytical approaches and methods for reconstituted and dry state analysis- using techniques including DSC, DVS, Raman, IR, XRD, DLS.

     

  • Andrew Bright

    Andrew Bright, Senior Scientist, Biopharma Process Systems Ltd

    Edmond Ekenlebie

    Edmond Ekenlebie, Principal Scientist, Biopharma Process Systems Ltd

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    15:10

    Session 2: Case studies

  • Sample case studies and discussion on how to use these techniques to answer specific questions
  • Andrew Bright

    Andrew Bright, Senior Scientist, Biopharma Process Systems Ltd

    Edmond Ekenlebie

    Edmond Ekenlebie, Principal Scientist, Biopharma Process Systems Ltd

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    15:40

    Afternoon Tea

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    16:00

    Session 3: Assessing structural properties of lyophilised materials

  • Visual and quantitative methods, including in situ vial quantification of mechanical properties
  • Practical exercise assessing typical structural patterns in freeze dried products
  • Andrew Bright

    Andrew Bright, Senior Scientist, Biopharma Process Systems Ltd

    Edmond Ekenlebie

    Edmond Ekenlebie, Principal Scientist, Biopharma Process Systems Ltd

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    17:00

    Closing Remarks

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Sune Klint  Andersen

    Sune Klint Andersen, Principal Scientist Spray Drying , Janssen Pharmaceutica NV

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    9:10

    Freeze drying of biologics: The essentials

    Patrick  Garidel

    Patrick Garidel, Process Sciences Department, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim

  • Short introduction to the freeze-drying process
  • Freeze-dried market products
  • Biologics in the dry state: what to consider?
  • Formulation principles for freeze-dried products
  • Process development of freeze-dried products
  • Primary packaging for freeze-dried products
  • Analytics for the characterisation of lyophilizates
  • Stability issues
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    9:50

    Use of old and new methods in optimising freeze drying cycles

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

  • Illustrate how existing technologies can be used
  • New and experimental methods are adding to our capabilities.
  • Off- line dynamic mechanical analysis
  • On-line impedance analysis
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    10:30

    Morning Coffee

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    11:00

    Scrutinizing the optimisation and scale up of freeze dried formulations and processes

    Robert Forbes

    Robert Forbes, Professor of Clinical Pharmaceutics, University Of Central Lancashire

  • What’s different at scale
  • Building and establishing robustness
  • New tools to deal with complex molecules and environments
     

     

  • clock

    11:40

    Freeze-Dried Product appearance: Looking at the material and the immaterial

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

  • Macroscopic parameters: shape, uniformity, skin formation, shrinkage, defects in gross morphology and root causes
  • Micro-collapse: is it acceptable?
  • What effects might micro-collapse have on the product?
  • How can it be detected and predicted?
     
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    12:20

    Networking Lunch

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    13:30

    Long term storage stability of FD biologics: Effects of storage temperature

    Daryl Williams

    Daryl Williams, Director of Development, Chem. Eng. Discovery, Imperial College London

  • Challenge of drying high protein content materials
  • Stress thermal stability studies on model IgG formulation
  • Physicochemical and bioactivity analysis
  • Novel mechanical/ structural analytical methods
  • clock

    14:10

    Predicting stability of freeze dried pharmaceuticals

    Eric Munson

    Eric Munson, Professor, Pharmaceutical Sciences, University of Kentucky

  • Tools currently used to predict stability
  • Challenges associated and errors
  • Reducing errors in the predicted stability value
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    14:50

    Afternoon Tea

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    15:20

    Formulation considerations in the development of liposomes in a freeze-dried format

    Maryam Hussain

    Maryam Hussain, Research Assistant/ PhD Student, University Of Strathclyde

  • Considerations of the advantages and challenges to freeze-drying of liposomes and nanomedicines
  • Strategies to formulate these systems as stable freeze-dried products
  • Methods to rapidly screen and identify suitable freeze-dried formats
  • clock

    16:00

    How to use water activity measurement and mathematical modelling to evaluate the stability of freeze-dried vaccines

    Erwan Bourles

    Erwan Bourles, Expert Scientist, Head Filling Drying Device, GSK

  • Definition of water activity
  • Examples of stability evaluation using Water activity measurement
  • Case Study on a vaccine formulation
  • clock

    16:40

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Sune Klint  Andersen

    Sune Klint Andersen, Principal Scientist Spray Drying , Janssen Pharmaceutica NV

    clock

    9:10

    QbD in spray drying vs lyophilisation

    Sune Klint  Andersen

    Sune Klint Andersen, Principal Scientist Spray Drying , Janssen Pharmaceutica NV

  • Quality-by-Design strategies for drying processes
  • Typical sources of variation for lyophilization and spray drying processes
  • Timing/conditions for initiating QbD for drying processes
  • Applying PAT in drying process QbD
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    9:50

    PAT technologies for moisture and temperature monitoring for lyophilisation process

    Dikshitkumar Khamar

    Dikshitkumar Khamar, Senior Scientist, Genzyme Ireland Ltd

  • Development of non-invasive moisture monitoring methods and examples
  • Using head space moisture analyzer
  • Using NIR probe
  • Temperature monitoring systems for pilot scale as well as commercial scale freeze-dryers
  • Pros and cons of such measurements and feasibility of using these techniques at commercial scale and sterile fill operations
  • clock

    10:30

    Morning Coffee

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    11:00

    Lyophilization of a synthetic small molecule with antiviral activity for oral delivery (case study)

    Miguela Vieru

    Miguela Vieru, Research & Development, PDMS - Parenterals & Liquids, Janssen Pharmaceutica NV

  • Formulation development for an antiviral agent with low aqueous solubility
  • Lyophilization of a formulation containing cyclodextrin
  • Freeze dried product characterization
  • Spray drying as alternative technique to stabilize the drug product formulation
  • clock

    11:40

    Through Vial Impedance Spectroscopy – A new PAT for freeze-drying cycle development

    Geoff Smith

    Geoff Smith, Professor of Pharmaceutical Process Analytical Technology, DeMontford University

  • Description of the system and the measurement principles
  • Characterization of ice and the unfrozen fraction
  • Determination of single vial product temperature and drying rates
  • Applications for process parameter determination (Kv, Rp)
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    12:20

    Networking Lunch

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    13:30

    Novel approaches to reducing subjectivity and enhancing quantification in characterisation methods pre- and postlyophilisation

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

  • Applications of Thermal Analysis by Structural Characterisation (TASC) in freeze-drying microscopy (FDM)
  • Training operators to recognise the onset of collapse and reducing operator-to-operator variation
  • Quantification of the effect and impact of annealing at different temperatures
  • The use of quantitative Young’s Modulus (elasticity) measurements to provide a better understanding of:
  • The significance of temperature gradients across shelves in freezing and drying for different formulations
  • The robustness of different formulations to different lyophilisation conditions
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    14:10

    In silico approaches to aid rational design of freeze dried formulations

    Mire  Zloh

    Mire Zloh, Emeritus Professor of Medicinal Chemistry, University of Hertfordshire

  • Importance of intermolecular interactions between excipients and actives for their stability and/or solubility
  • In silico freeze drying of pharmaceutical formulations
  • Case studies: from a small molecule to protein therapeutics
  • Perspectives on applications of in silico tools in rational design of formulations
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    14:50

    Afternoon Tea

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    15:20

    PANEL - The future of novel technology for predicting cycles within the lyophilisation field

  • The current novel technologies which have been recently introduced into the market
  • The benefits of these technologies over existing technologies
  • Barriers to entry into implementation e.g. regulations, pricing etc
  • How can technologies be further developed?
  • Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

    Sune Klint  Andersen

    Sune Klint Andersen, Principal Scientist Spray Drying , Janssen Pharmaceutica NV

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    clock

    16:00

    Chairman’s Closing Remarks and Close of Day Two


    Director of Development, Chem. Eng. Discovery
    Imperial College London
    Senior Scientist
    Genzyme Ireland Ltd
    Professor, Pharmaceutical Sciences
    University of Kentucky
    Expert Scientist, Head Filling Drying Device
    GSK
    Professor of Pharmaceutical Process Analytical Technology
    DeMontford University
    Director of R&D
    BioPharma Technology
    Research Assistant/ PhD Student
    University Of Strathclyde
    Research & Development, PDMS - Parenterals & Liquids
    Janssen Pharmaceutica NV
    Emeritus Professor of Medicinal Chemistry
    University of Hertfordshire
    Process Sciences Department, Head of Pharmaceutical Basic Development
    Boehringer-Ingelheim
    Principal Scientist
    NIBSC
    Professor of Clinical Pharmaceutics
    University Of Central Lancashire
    Principal Scientist Spray Drying
    Janssen Pharmaceutica NV

    Sponsors and Exhibitors

    Supporters

    [2018 ATTENDEE LIST] - UPDATED

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    [SPONSOR] - NEXTARO'S PRODUCT LINE

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    [SPEAKER INTERVIEW] - CHAIRMAN: Sune Klint Andersen - Janssen

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    [2016 ATTENDEE LIST]

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    [2017 ATTENDEE LIST]

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    [PAST ATTENDEE BREAKDOWN] - INFOGRAPHIC OF LAST YEAR

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    [WORKSHOP A] - FULL DETAILS, OVERVIEW & BIO

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    [WORKSHOP B] - FULL DETAILS, OVERVIEW & BIO

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    [2017 PRESENTATION] - Pfizer

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    [DAY 1 | 13TH JUNE 2018] - FULL PROGRAMME

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    [DAY 2 | 14TH JUNE 2018] - FULL PROGRAMME

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    [2018 BROCHURE] - PHARMA FREEZE DRYING TECH

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    [LIST OF 2018 SPEAKERS] - THIS YEAR'S LINE-UP

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    [SPEAKER INTERVIEW] - Dikshitkumar Khamar, Senior Scientist, Genzyme Ireland

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    [SPEAKER INTERVIEW] - Paul Matejtschuk, Principle Scientist, NIBSC-MHRA

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    Sponsors and Exhibitors


    Nextaro

    Sponsors and Exhibitors
    http://www.nextaro.com

    nextaro® is the quality benchmark for reconstitution of lyophilized pharmaceutical components. With its key advantages being the patented screw system and the optimized handling through the use of two component plastic, nextaro provides the market's best stability, and is suitable for people with ailments or those who are in a hurry. The modular design makes nextaro® customizable to meet the individual requirements of each drug. Contact us today and top off your high quality application set with the device it deserves.

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    Technology Networks

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    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


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    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


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    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.


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    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


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    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


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    Biocompare

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    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


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    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


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    GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.


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    IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.


    Inderscience Publishers

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    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.


    Gate2Biotech

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    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.

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