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  1. The Asia Pacific Region / Part 3: CMC Requirements during New Drug Application and Post-Approval Life-Cycle Management in China / Beitrag aus Pharm. Ind. 81, Nr. 9, 1226-1231 (2019)

    17.10.2019
    As the second-largest pharmaceutical market in the world, China becomes more and more important for the global pharmaceutical industry. Although the Chinese regulatory agency’s intent is the harmonization with the ICH regulations, the requirements for the submission of a clinical trial application (CTA), new drug application (NDA) and post-approval changes in China still differ from the global standards. This article provides an overview of the regulatory landscape in China and gives detailed information on harmonization aspects, contract manufacturing organization, the so-called master file bundling review and post-approval change management. The upcoming revision of the Chinese Pharmacopoeia in 2020 is also considered. (...)
  2. NOXXON Enrolls First Patient in the Phase 1/2 Clinical Trial Combining NOX-A12 With Radiotherapy in Newly Diagnosed Brain Cancer

    17.10.2019
    NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today the enrollment and first treatment of a patient with newly diagnosed brain cancer in a phase 1/2 clinical trial. The study investigates a combined therapy of increasing doses of the CXCL12 inhibitor, NOX-A12, and external-beam radiotherapy. Within this study, NOX-A12 administration in planned for up to six months. The anticipated mode of action of NOX-A12 is the inhibition of the unwanted influx of bone marrow-derived “repair cells” to the tumor following radiotherapy-induced breakdown of the vasculature in the tumor. These “repair cells” act by replacing the tumor’s blood vessels that were destroyed by the irradiation, which ultimately results in disease recurrence. (...)
  3. Healx Secures $56M in Series B Financing, Launches Global Accelerator Programme for Rare Diseases

    17.10.2019
    Healx, the AI-powered and patient-inspired technology company specialising in treatments for rare diseases, today announces that it has raised $56 million in a Series B financing round, led by one of Europe’s largest VC firms Atomico and joined by Intel Capital, Global Brain and btov Partners. All previous investors, including Balderton Capital, Amadeus Capital Partners, and Jonathan Milner also participated in the round. The financing will be used to develop the company’s therapeutic pipeline and to launch its global Rare Treatment Accelerator programme. / Where the traditional drug discovery model takes more than a decade and can run into the billions of dollars, Healx’s AI-driven approach makes the process faster, more efficient and more cost-effective. With the launch of the Rare Treatment (...)
  4. Romaco and Huhtamaki at the CPhI in Frankfurt

    17.10.2019
    First recyclable strip packaging / At the upcoming CPhI Worldwide in Frankfurt (Germany), Romaco and Huhtamaki will show the first recyclable strip packaging for pharmaceutical solids. An HM 1-230 heat-sealing machine from Romaco Siebler will be used to manufacture the Push Packs. / Pharmaceutical manufacturer Romaco Siebler and foil specialist Huhtamaki are about to launch the market's first ever recyclable unit dose packaging for solid pharmaceutical products. The newest Push Pack model is made from recyclable polyolefin laminate. The unique structure of the strip packaging foil enables it to be recycled back into the material loop. More than 90 percent of the components which are used to make the packaging belong to the same (...)

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  1. Robin Dietrich

    Beitrag aus der Ausgabe 8/2019 der Zeitschrift pharmind

    Anforderungen der DIN EN ISO 19011:2018 für die Pharma- und Medizintechnikindustrie

    Dr. Thomas Behnisch und Robin Dietrich · auceris GbR, Mellingen

    Im Bereich der Pharmaindustrie und Medizintechnik ist die Lieferantenqualifizierung ein wesentlicher Bestandteil der gesetzlichen Forderungen. Die Bewertung von Lieferanten und Dienstleistern auf Übereinstimmung (Compliance) mit „spezifischen Kriterien und anzuwendenden regulatorischen Anforderungen ist ein elementarer Beitrag zur Sicherung der Produktqualität, Risikominimierung für den Patienten sowie für die Wettbewerbsfähigkeit und (...)

  2. Beitrag aus der Ausgabe 8/2019 der Zeitschrift pharmind

    Koch • Temperaturmapping von Heiz- und Kühlgeräten

    Patrick Koch · CSL Behring Lengnau AG, Lengnau (Switzerland)

    In der vorliegenden Leistungsqualifizierung (Performance Qualification, PQ) mittels Temperaturmapping wird anhand eines Beispiels von einem Tiefkühlschrank gezeigt, wie ein solches Mapping in einem Pharmaunternehmen durchgeführt werden kann. Zuerst wird die leere Kammer über mindestens 24 h gemessen, um die Homogenität des Geräts zu überprüfen, sowie die Worst-Case-Position zu ermitteln. An dieser Position (Hot- oder Cold-Spot) wird die (...)

  3. Dr. Norbert Waldöfner

    Beitrag aus der Ausgabe 9/2019 der Zeitschrift pharmind

    Waldöfner • Qualitätssicherung durch Outsourcing

    Dr. Norbert Waldöfner · blue inspection body GmbH, Münster

    Der Artikel befasst sich mit dem Thema, wie Arzneimittelhersteller die Qualität von GMP-Audits sicherstellen können, wenn sie diese durch externe Audit-Dienstleister durchführen lassen. Dabei werden die gesetzlichen Grundlagen einerseits sowie die spezifischen Anforderungen zur Einhaltung der relevanten Guidelines für GMP-Audits bei Wirkstoffherstellern andererseits detailliert beleuchtet. Insbesondere wird dabei der Frage nachgegangen, welche (...)

Top Themen

  1. Beitrag aus der Ausgabe 9/2019 der Zeitschrift pharmind

    Microbial integrity test for preservative-free multidose eyedroppers or nasal spray pumps

    Marx et al. • Microbial integrity

    Degenhard Marx1, Thorsten Bartsch2, Reinhold Wohnhas2, Walter Zwisler3 · 1Aptar Radolfzell GmbH, Radolfzell 2 · Labor Dr. Merk & Kollegen GmbH, Ochsenhausen 3 · Zwisler Laboratorium GmbH, Konstanz

    Preservative-free multi dose dispensers are now well established on the market, e.g., for nasal spray or eye drop products. The technology behind such container closures systems ensures that the container content remains sterile during storage within shelf life and the in use period which lasts often at least for 28 days. For historically used standard multidose devices, the sterility of the formulation had to be maintained by the added (...)

Vorschau (Änderungen vorbehalten)

  1. Primary Packaging Solutions for Wearable Injectors
    Beitrag aus der nächsten Ausgabe 10/2019 der Zeitschrift pharmind
    (erscheint am 29. Okt. 2019)

    Primary Packaging Solutions for Wearable Injectors

    Biopharmaceutical drugs are a fast-growing business segment in the pharmaceutical industry. Due to their high dosage and protein concentration, they have usually been injected intravenously in hospitals. The trend towards subcutaneous injection and self-administration is driving the development of wearable injectors to reduce costs, improve the patient experience, achieve differentiation and shorten time to market. The primary packaging used in such wearable injectors plays a key role in protecting the drug from contamination and ensuring optimal functionality. This article provides an overview of the pharmaceutical container solutions available for wearable injectors.