
News from GMP Market and about Valicare
-
Valicare
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
-
GMP Market
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
23th of June 2017: GMP audits & inspections in the pharmaceutical industry
-
ATMP
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
News from around the world
Our international press review shows a selection of news and latest articles on Advanced Therapy Medicinal Products (ATMP), Chimeric Antigen Receptor (CAR) T-Cell Therapy, Tumor Infiltrating Lymphocytes (TIL) and tissue engineerd products (TEP).
Pfizer and BioNTech confirm high efficacy and no serious safety concerns through up to six months following second dose in updated topline analysis of landmark COVID-19 vaccine study
02.04.2021 | World Pharma News
April 2: The Week in Cancer News
02.04.2021 | Cancer TodayA study indicates that people are delaying medical care until they are eligible for Medicare, leading to missed cancers, and the Food and ...
PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021)
02.04.2021 | PharmaShotsPfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19
Choosing the Right Viral Vector for a Gene Therapy - Global Genes
02.04.2021 | Global GenesGene therapy is promising to provide treatments and potential cures for a long list of rare, genetic diseases. A key element of these ...
Stem cell transplants prevent relapses of most common childhood cancer
02.04.2021 | Science CodexChildren and young adults who receive CAR T-cell therapy for the most common childhood cancer - acute lymphoblastic leukemia - suffer ...
Role of Epigenetic Regulation in Plasticity of Tumor Immune Microenvironment
02.04.2021 | FrontiersThe tumor immune microenvironment (TIME), an immunosuppressive niche, plays a pivotal role in contributing to the development, progression ...
The evolution of commercial drug delivery technologies
01.04.2021 | NatureThis Review Article discusses how delivery challenges associated with small molecules, nucleic acids, peptides, proteins and cells led to ...
IQWiG soll Konzept für anwendungsbegleitende Datenerhebung...
01.04.2021 | Arzteblatt.de
Celltrion Healthcare receives positive CHMP opinion for subcutaneous formulation of infliximab, Remsima® SC, for direct use of subcutaneous therapy without IV loading in adults with rheumatoid arthritis
31.03.2021 | Le Lezard (EN)
A T-cell independent universal cellular therapy strategy through antigen depletion
30.03.2021 | bioRxivCD19-targeting chimeric antigen receptor (CAR) T-cell therapeutics is a revolutionary, novel and successful treatment for B-cell ...
Celonic will manufacture over 100 million doses of Curevac’s COVID-19 Vaccine Candid...
30.03.2021 | BioPharmAnalysesCureVac and Celonic Group have conclud a partnership for the production of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV. ...
Systematic analysis of CD39, CD103, CD137 and PD-1 as biomarkers for naturally occurring tumor antigen-specific TILs
30.03.2021 | bioRxivThe detection of tumor-specific T cells in solid tumors is integral to the interrogation of endogenous antitumor responses and to the ...
FDA Approves Bristol Myers Squibb and bluebird bio’s CAR T Cell Therapy for Refractory Multiple Myeloma
29.03.2021 | BioPharm InternationalAbecma is the first B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy for the treatment of adult patients ...
Bristol Myers Squibb Expands Devens Facility for Cancer Research
29.03.2021 | The New England CouncilNEC member Bristol Myers Squibb, a New York-based biopharmaceutical company, recently added a 244,000 square-foot expansion to their Devens ...
Rocket Pharmaceuticals Receives EMA Priority Medicines (PRIME) Designation for RP-L201 Gene Therapy for Treatment of Leukocyte Adhesion Deficiency-I
29.03.2021 | Le Lezard (EN)
We are there for you
Contact us if you have any questions. We will gladly answer and advise you.