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10th of June 2024: Robotics and Automation for ATMPs
The integration of robotics and automation in the production of Advanced Therapy Medicinal Products (ATMPs) is revolutionizing the industry. Valicare offers innovative solutions to make processes more efficient and secure. Read more about it. >>>
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22th of May 2024: EU Commission adopts pharmaceutical reform package as an essential part of the planned EU pharmaceutical strategy
Find out more about the reforms of the EU regulatory framework for medicinal products adopted by the European Parliament. >>>
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07th of May 2024: Do your methods comply with the new ICH requirements?
Discover the latest developments in pharmaceutical analytics! Learn how the new ICH guidelines Q2(R2) and Q14 redefine the standards for method development and validation and drive quality assurance in the industry.>>>
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08th of December 2023: FDA approves Casgevy
The success story of CRISPR/Cas9 continues: The FDA approved Casgevy in the USA on December 8th 2023. This makes Casgevy the first FDA-approved therapy to use CRISPR/Cas9. This is a major step forward in the field of ATMPs. We are eager to see how the success story continues. >>>
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05th of December 2023: The first CRISPR/Cas9-based therapy has reached the market
The admission of Casgevy (Exagamglogene autotemcel) opens a new chapter in CRISPR/Cas9-based gene therapy and ATMP manufacture. >>>
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10th of November 2023: Successfully transferring ATMPs to patients and market
With the "cult.tainer®", Valicare offers a turnkey production concept for the GMP-compliant manufacturer of iATMPs/ATMPs. Further information also about the free cult.tainer® web session on 5th, 2023 and access further information here. >>>
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22th of August 2023: Prohibition of PFAS – Evaluate, assess risks, time to act
In the last years the restrictions of PFAS increased rapidly. Since early 2023 a complete prohibition of PFAS is discussed.
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2th of August 2023: Revision of Annex 1
New approaches are required soon! A challenge for your company? Get an overview about the most important upcoming changes
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13th of June 2023: ATMPs are high potentials in the treatment of previously incurable diseases
Their production remains a challenge. Read here how to coordinate planning, construction of the production plant and implementation of the production processes in parallel and efficiently.
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GMP for manufacturers in pharma, biotech, medical devices & ATMPs.
We have been offering a broad spectrum of classical and special GMP services for over 20 years now. Our GMP experts will advise and support you.
Learn moreATMP 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).
CGTLive®’s Weekly Rewind – June 28, 2024
28.06.2024 | CGTLiveReview top news and interview highlights from the week ending June 28, 2024.
Multiples Myelom: Aggressive Tumoren früh erkennen
28.06.2024 | Science-Online.orgTeilen: 28.06.2024 12:20 Forschungserfolg durch erste umfassende Untersuchung des Genoms und Proteoms ...
Novel Engineered Immunotherapy Improves Anti-Tumor Response
27.06.2024 | LabrootsCancer therapy is ever changing as technology improves to better understand our immune systems. Immunotherapy is a form of cancer treatment ...
Neue Therapieoption für ALS in Sicht
27.06.2024 | healthcare-in-europe.comDie Amyotrophe Lateralsklerose (ALS) ist eine unheilbare, schwere Erkrankung des Nervensystems. In ihrem Verlauf sammeln ...
RNA Vaccines For Cancer
27.06.2024 | Science.orgPeople have been trying for decades to get “vaccines” and “cancer” into the same sentence, and it’s no wonder. Vaccines can be tremendous ...
FDA Grants Accelerated Approval to Epcoritamab in R/R Follicular Lymphoma
26.06.2024 | Oncology - CancerNetworkFindings from the EPCORE NHL-1 trial support the FDA approval of epcoritamab in relapsed/refractory follicular lymphoma.
Advancing Wound Care with Electrospinning
26.06.2024 | Nanoscience InstrumentsWound care solutions are essential in medicine to protect injuries from infection, manage exudate, and create an optimal healing ...
Die Welt der Bakterien entschlüsseln
26.06.2024 | DeutschesGesundheitsPortalHIRI-Forschende entwickeln neuen Ansatz zur DNA-Transformation und Genmutation in Bakterien
FULL-LENGTH ARTICLEImmunotherapyAlternative target recognition elements for chimeric antigen receptor (CAR) T cells: beyond standard antibody fragments
26.06.2024 | ScienceDirectAuthor links open overlay panelMatthew A. Nix 1 2, Arun P. Wiita 1 3 4 5
CT-0525 Gains FDA Fast Track Designation in HER2-Overexpressing Solid Tumors
25.06.2024 | Targeted OncologyCT-0525 has received a fast track designation from the FDA for the treatment of solid tumors that overexpress HER2.
Sealed for Safety: Understanding Injectable Drug Container Closure Systems
25.06.2024 | WestA container closure system (CCS) is comprised of packaging components, such as a vial and stopper, that together, contain and protect the ...
Aufbau von Translationszentrum für Gentherapien und Zelltherapien in Berlin beginnt
25.06.2024 | CHEManagerDas Projekt wird maßgeblich von der Bundesregierung sowie dem Land Berlin finanziell gefördert und unterstützt. ...
06.25.24 -- Managing Change In Vaccine Production With All Stakeholders
25.06.2024 | BioProcess OnlineSPONSOR
CGTLive®’s Weekly Rewind – June 21, 2024
21.06.2024 | CGTLiveReview top news and interview highlights from the week ending June 21, 2024.
Erstmals am UKD: CAR-T Zellen zur Behandlung von Autoimmunerkrankungen
21.06.2024 | Cityblick 24An der Uniklinik Düsseldorf wurde der erste Sklerodermie-Patient unter Einsatz der CAR-T-Zell- ...
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