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| News: Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency |
FDA is issuing this guidance to provide manufacturers of licensed and investigational cellular therapy and gene therapy (CGT) products with risk-based recommendations to minimize potential transmission of the novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This guidance is intended to supplement the recommendations to drug and biological product manufacturers provided in FDA’s “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing; Guidance for Industry” issued in June 2020 (Ref. 1) (June 2020 GMP Guidance). The recommendations in this guidance specifically consider the source material (cells and/or tissues) recovered from donors and how the CGT product will be manufactured (e.g., cell expansion in culture, viral reduction steps, formulation).
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| Conference: Cell & Gene Therapy Manufacturing & Commercialization Digital Week |
The Cell & Gene Therapy Manufacturing & Commercialization Digital Week is a complimentary webcast series that focuses on the hot topics in the cell & gene therapy industry today.
Taking place on February 16-19 2021, the web series focus is on pure play cell therapies, providing key case studies to help improve all things manufacturing, process development and more. Next week you will be able to watch live video presentations from the comfort of your home, lab, or office so sign up now and don't forget to invite your colleagues along to Cell & Gene Therapy Manufacturing & Commercialization Digital Week.
Register now... |
| Conference: ISBioTech 10th Spring Meeting Redux — Viral Vectors and Vaccines |
The International Society for BioProcess Technology (ISBioTech) is delighted to announce their fully virtual 10th Spring Meeting Redux, to convene March 15-17, 2021. Join them for this world renowned conference on the development and production of viruses needed for vaccines, plus gene and cell therapies. A reliable tool in the immunologist’s arsenal for centuries, viral vectors continue to play a vital role in inoculation around the world. Designed with professional development in mind, this virtual meeting will feature live presentations and Q&A, as well as a host of networking opportunities. You’ll learn and share with the industry’s leading organizations as you hear from the individuals actually doing the work in labs and production suites. Registration is currently open.
Register now... |
| Conference: Macrophage Therapy Symposium |
The Macrophage Therapy Symposium will outline the key approaches for macrophage stimulation to limit immune suppression, angiogenesis and the resultant resistance to immune therapy.
Join us on March 23 with key academics, innovative biotechs and pioneering pharmaceutical companies to meet and unpack the mechanisms and paradigms surrounding the key targets for macrophage modulation.
Register now... |
| Conference: Formulation & Delivery Europe: ONLINE |
Registration is now open for our Formulation & Drug Delivery Europe: Online, taking place 21-22nd of April 2021 on our virtual event platform. The two-day congress will explore the major challenges facing drug product development and advanced drug delivery, including new & novel therapeutic modalities, the latest formulation strategies as well as process development & continuous manufacturing.
Register now... |
| Conference: Neuroimmunology Drug Development Summit |
Returning on April 27-29, the 3rd Neuroimmunology Drug Development Summit will uncover how leading companies in this emerging field are discovering immune-modulating targets and deploying immuno-neurology across clinical case studies. We will put the spotlight on the latest learnings across microglia, astrocytes, STING, TREM2 and more to help pave the way to translating key technological and mechanistic insights towards the clinic.
Register now... |
| Conferences |
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16 - 18 February 2021, 28th Annual Molecular Med Tri-Con Virtual Conference & Expo, Online event |
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16 - 18 February 2021, CAR-TCR Digital Summit Europe, Online event |
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16 - 19 February 2021, Cell & Gene Therapy Manufacturing & Commercialization Digital Week, Online event |
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22 - 25 February 2021, 4th Annual Gene Therapy for Rare Disorders, Boston, MA |
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23 February 2021, Cell & Gene Therapy Day, Online event |
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23 - 25 February 2021, 9th Neurodegenerative Drug Development Summit, Online event |
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23 - 26 February 2021, IO360° Summit - Gene Therapies, Online event |
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9 - 11 March 2021, 2nd Gene Therapy for Blood Disorders meeting, Online event |
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15 - 17 March 2021, International Society for BioProcess Technology 10th Spring Meeting - Viral vectors and vaccines, Norfolk, Virginia |
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16 - 17 March 2021, 4th Annual Bioprocessing Summit Europe Virtual, Online event |
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23 March 2021, Macrophage Therapy Symposium, Online event |
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23 - 25 March 2021, Innate Killer Summit 2021, Online event |
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23 - 25 March 2021, Gene Therapy Patient Engagement, Online event |
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24 - 25 March 2021, Gene and Cell Therapies CMC & Vector Manufacturing Online Summit, Online event |
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30 March - 1 April 2021, Gene Therapy Comparability, Online event |
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5 - 8 April 2021, Cell Therapy Manufacturing Asia & BioProcess International Asia, Online even |
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20 - 21 April 2021, Formulation & Delivery Europe: Gene and Cell Therapies, Online event |
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27 - 29 April 2021, Neuroimmunology Drug Development Summit, Online event |
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28 April 2021, World Orphan Drug Congress USA Virtual, Online event |
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11 - 14 May 2021, American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting, Online event |
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18 - 20 May 2021, Genetic Vaccine Development for Infectious Diseases Summit, Online event |
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25 - 27 May 2021, Gene Therapy Analytical Development Europe, Online event |
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25 - 27 May 2021, Gene Therapy for Muscular Disorders, Online event |
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26 - 28 May 2021, International Society for Cell and Gene Therapy (ISCT) New Orleans virtual meeting, Online event |
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8 - 10 June 2021, Next Generation Gene Therapy Vectors, Online event |
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29 - 30 June 2021, Formulation & Delivery US: Gene and Cell Therapies, San Diego, CA |
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25 - 27 August 2021, World Orphan Drug Congress USA, Maryland, USA |
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31 August - 2 September 2021, CAR-TCR Summit USA, Boston, MA |
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1 - 3 September 2021, World Smart Bioprocessing: Pharma 4.0 Summit, Berlin, Germany |
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21 - 22 September 2021, Formulation & Delivery UK: Gene and Cell Therapies, London, UK |
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22 - 23 September 2021, Oligonucleotide Therapeutics and Delivery conference, London, UK |
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12 - 13 October 2021, Pharma Europe 2021 - Cell & Gene Therapies, Barcelona, Spain |
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18 - 20 October 2021, Advancing Gene Therapy 2021, Boston, MA |
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19 - 21 October 2021, XXVIII Congress of the European Society of Gene and Cell Therapy (ESGCT), Brussels, Belgium |
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10 - 11 November 2021, Pharma Manufacturing: Gene and Cell Therapies, Online event |
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22 - 23 November 2021, Ophthalmic Drugs Conference - Gene Therapies, London, UK |
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Read more... |
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Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines. Other information websites created and maintained by the owner of Gene Therapy Net are Dengue Virus Net, Influenza Virus Net, Ebola Virus Net, Chikungunya Virus Net, Zika Virus Net and Corona Virus Net.
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