News
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)
6th of December 2018: Validation-from concept to implementation
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
4th of February 2021: Vaccinations with mRNA-based medicinal products
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: 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
14th of November 2017: Valicare GmbH celebrates its 15th anniversary
13th September 2017: Valicare advises start-ups and biotech companies on GMP compliance
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).
Adrián González-Brito and Mireia Uribe-Herranz* ...
Abstract Organoids bridge the gap between 2D cell lines and in vivo studies. With their 3D organization and cellular heterogeneity, adult ...
With the publication of EU GMP Annex 1: Manufacture of Sterile Medicinal Products on 25 August 2022, the long-awaited wording regarding the ...
Cancer is “the emperor of all maladies,” as Pulitzer Prize-winner Siddhartha Mukherjee put it. We have been walking, running, wearing ...
Tech workers will upgrade from big tech to biotech In recent months, over 120,000 workers have left the tech sector and are on the hunt ...
... https://doi.org/10.1016/j.prp.2022.154289Get rights and content ...
Getting more gene and cell therapy treatments to patients ...
Cellular adhesion remains a fundamental component to cell-cell communication GETTY Cells are the fundamental unit of life. The average ...
Nanomaterials such as nanotubes are increasingly used in medical devices, as their benefits are being recognized across the industry. This ...
Abstract We investigated a method for automatic skin tissue characterization based on optical coherence tomography (OCT) imaging. We ...
Avectas have launched its Solupore platform that addresses the limitations of current transfection technologies and aims to advance ...
LEUVEN, Belgium—Imec, a research center for nanoelectronics and digital technologies based here, is developing tools, modules and nanochips ...
... by Utkarsh Mankar ...
... https://doi.org/10.1016/j.biopha.2022.114061Get rights and content ...
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