News from GMP Market and about Valicare
13th of April 2023: SMEPAC Test to Measure the Tightness of Containment Systems
29th of August 2022: Computerized System Validation (CSV) – GAMP 5 Second Edition
1th of June: New ICH Q14 Guideline: Analytical procedure development
18th of February: Revision of ICH Q9 (R1) Guideline on Quality Risk Management
15th of April 2021: WHO publishes decision on setting acceptance criteria for cleaning validation
8th of January 2021: Integrated Qualification and Validation Guide
2th of December 2020: Good Manufacturing Practice (GMP)
26th of October 2020: Nitrosamines in active substances and finished medicinal products
15th of June 2020: Current trends and outlook on cleanroom requirements
12th of June 2020: Pharmaceutical procurement & supplier qualification
28th of November 2019: Risk management: must-have for any pharmaceutical company
30th of July 2019: Medical cannabis is a medicinal product
23th of April 2019: Ensure your Compliance of Good Distribution Practice (GDP)
27th of February 2019: Requalification – GMP-requirements for the pharmaceutical industry are valid worldwide
6th of December 2018: Validation-from concept to implementation
20th of September 2018: Risk based qualification in the gmp-area is both an opportunity and a challenge.
28th of February 2018: End of transition period for EN ISO 13485:2016
28th of February 2018: The new draft of Annex 1 of the EU GMP guideline
28th of February 2018: New Aide memoire of ZLG for process validation
22th of February 2018: Filling of sterile injectables – validation of high-tech equipment
18th of December 2017: Iran/IFDA, Turkey/TMMDA and Mexico/COFEPRIS are new members of PIC/S
27th of May 2021: Updated guideline for medicinal products containing modified cells provides innovations, recommendations and improvements to be implemented
10th of February 2021: FDA approves Breyanzi®, a new CAR-T cell therapy drug.Fourth approved CAR-T cell therapy soon to be available in Europe?
4th of February 2021: Vaccinations with mRNA-based medicinal products
12th of October 2020: Live Online Conference-Quality, Safety and GMP for Advanced Therapy Medicinal Products (ATMPs)
9th of October 2020: 2nd APV Interactive Workshop on ATMP
24th of September 2020: MSC & Covid-19
24th of August 2020: FDA opens up approval process for RYONCYL™
4th of August 2020: FDA approves CAR T-cell therapy Tecartus™
17th of January 2020: BioNTech SE acquires Neon Therapeutics
9th of January 2020: New legal regulations governing the application of ATMPs
24th of September 2019: Complex manufacturing processes are a main challenge for the GMP-compliant production of CAR T cells
24th of September 2019: How to handle Out-of-Specification (OOS) batches of ATMPs?
17th of September 2019: Valicare expresses its support for the RESTORE Consortium
20th of March 2019: Patient free of HIV after stem-cell therapy
13th of March 2019: The crux of penicillin application in cell culture for ATMP manufacturing
18th of February 2019: ATMP-GMP production – innovative patient-specific therapies are exceptional
31th of January 2019: Draft guideline on the requirements for ATIMPs in clinical trials, EMA
22th of November 2017: European Commission, EC, adopts GMP for ATMP Guideline
30th of October 2017: New action plan to foster development of advanced therapies
18th of September 2017: ATMPs – patient-specific drugs on their way to market
1st of September 2017: Response to ATMP GMP Guideline
2th of July 2017: Cell-based gene therapy for the ALL treatment receives FDA approval
19th of June 2017: “Annual Report 2016” of EMA indicates a positive trend for ATMP
25th of July: Valicare becomes 20 years old
23th of October 2020: Valicare Extends GxP Expertise
12th of October 2020: Valicare expands GxP Consulting-Team
22th of July 2020: Use public funding for consulting services!
16th of January 2020: Bosch Packaging Technology becomes Syntegon Technology
30th of July 2019: ECA certified API Production Manager & certified APIC Auditor
27-29th of June 2019: Strategy meeting of Slovak Valicare s.r.o. in Turna
24th of June 2019: Valicare Slovakia opens new location in Turná
12th of June 2019: J.P. Morgan Corporate Challenge in Frankfurt
5-6th of June 2019: Infomeeting der Valicare GmbH in Würzburg
19th of March 2019: ZellTherQC-Workshop at EBM in Lübeck
1th of October 2018: Valicare GmbH welcomes five new employee at Frankfurt am Main
7th of September 2018: Valicare GmbH supports Therabionic a German/American medical device manufacturer
14th of November 2017: Valicare GmbH celebrates its 15th anniversary
13th September 2017: Valicare advises start-ups and biotech companies on GMP compliance
News from around the world
Our international press review contains a selection of news and recent articles on advanced therapy medicinal products (ATMPs), chimeric antigen receptor T-cell therapy (CAR), tumor infiltrating lymphocytes (TILs) and bioengineered tissue products (TEPs).
FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa19.05.2023 | FDA
For Immediate Release: May 19, 2023 ...
A Guide to Mesenchymal Stem Cell (MSC) Markers19.05.2023 | Biocompare
Mesenchymal stem cells are non-hematopoietic multipotent precursor cells that can differentiate into a variety of cell types, including ...
“Untargeting” autoantibodies using genome editing, a proof-of-concept study19.05.2023 | Science Direct
... https://doi.org/10.1016/j.clim.2023.109343 ...
Imugene receives FDA approval to start human trial of CAR-T cell therapy for solid tumours19.05.2023 | Small Caps
Cancer immunotherapy house Imugene (ASX: IMU) has received US Food and Drug Administration (FDA) approval to start a human trial targeting ...
Rescued from the rubbish bin: How the thymus could stop organ transplant rejection18.05.2023 | BC Children's Hospital Research Institute
Polymeric nanoparticles containing babassu oil: A proposed drug delivery system for controlled release of hydrophilic compounds18.05.2023 | Science Direct
... https://doi.org/10.1016/j.chemphyslip.2023.105304 ...
Around the Helix: Cell and Gene Therapy Company Updates – May 17, 202317.05.2023 | CGTLive
Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.
EMA Publishes Annual Report for 202217.05.2023 | Pharmaceutical Technology
The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.
Spinnenseide für Gewebe und Implantat17.05.2023 | medizin & technik
Evolving Tools and Perspectives for the Development of Cell and Gene Therapies16.05.2023 | Applied Clinical Trials
This year marks the first time multiple gene therapies for the same non-oncology rare disease may be market authorized in the United States ...
FDA Awards FTD of IMPT-314 for B-Cell Mediated Malignancies16.05.2023 | Targeted Oncology
The fast track designation to IMPT-314 is for the treatment of multiple types of B-cell lymphoma in patients who previously received 2 or ...
ReviewViral Vectors, Exosomes, and Vexosomes: Potential armamentarium for delivering CRISPR/Cas to cancer cells16.05.2023 | Science Direct
... https://doi.org/10.1016/j.bcp.2023.115555 ...
Advanced flexible materials made from nanocellulose16.05.2023 | Nanowerk
May 16, 2023 Advanced flexible materials made from nanocellulose ( Nanowerk Spotlight ) Nanocellulose, a specialized type of cellulose ...
Researchers map RNA to inform selection of stem cells for therapeutic applications12.05.2023 | The Science Advisory Board
By Nick Paul Taylor, The Science Advisory Board contributing writer ...
What is the Best Lymphoma Treatment After CAR T Therapy Fails?12.05.2023 | Cancer Health
... iStock/Catalin Rusnac CU Cancer Center member Ajay Major published research showing that checkpoint inhibitor therapies are not ...
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