Cleanroom Industry News Articles

New ISPE Guide Includes Updated Guidance for Controlled Temperature Chambers

ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition).

New ISPE Guide for Controlled Temperature Chambers

ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition).

SaniSure Announces the Acquisition of GL Engineering to Globally Expand its Drug Product Fill and Finish Solutions

SaniSure, a global developer and manufacturer of single-use technology for the biopharmaceutical industry, announced today it has acquired GL Engineering (GLE) of East Hanover, New Jersey.

Taiyo Pharma Tech to Establish Gene Therapy Manufacturing Using Cytiva’s FlexFactory™ Solution

Cytiva’s FlexFactory is a one-stop solution for equipment and services following single-use technology and a modular design tailored to the manufacturer’s needs.

Amcor to expand healthcare packaging cleanrooms in Ireland

Amcor to expand healthcare packaging cleanrooms in Ireland

Through this investment, the Sligo site will feature Class 7 cleanroom manufacturing environments and state-of-the art thermoforming operations, fully certified to ISO 13485 standards and meeting the highest regulatory requirements.

Northvolt to Build €4 Billion Battery Gigafactory in Northern Germany

Northvolt to Build €4 Billion Battery Gigafactory in Northern Germany

The Swedish electric vehicle battery manufacturer says it will construct a major new production facility in the city of Heide near Germany’s North Sea coastline.

Celerion Expands Early Phase Clinical Pharmacology Units

Celerion Expands Early Phase Clinical Pharmacology Units

Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, has announced completion of additions to its research capacity and services

Micron Launches World’s First 176-Layer NAND in Mobile Solutions to Power Lightning-Fast 5G Experiences

Micron Launches World’s First 176-Layer NAND in Mobile Solutions to Power Lightning-Fast 5G Experiences

Micron Technology, Inc., announced today it has begun volume shipments of the world’s first 176-layer NAND Universal Flash Storage (UFS) 3.1 mobile solution. Engineered for high-end and flagship phones, Micron’s discrete UFS 3.1 mobile NAND unlocks 5G’s potential with up to 75% faster sequential write and random read performance than prior generations,1 enabling downloads of two-hour 4K movies2 in as little as 9.6 seconds.

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Marker Therapeutics Announces Opening of New cGMP Manufacturing Facility

Marker Therapeutics Announces Opening of New cGMP Manufacturing Facility

Marker Therapeutics, Inc., a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications…

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Exyte Builds First ExyCell® Facility in Shanghai

Exyte Builds First ExyCell® Facility in Shanghai

Exyte has successfully completed the construction of the first ExyCell® facility in China, the CliniMACS Cell Factory® of Miltenyi Biotec, a global provider of integrated solutions for Advanced Therapy Medical Products (ATMPs). The patented ExyCell technology was developed by Exyte as an end-to-end, integrated facility solution with standardized and modularized elements. These pre-configured and pre-fabricated modules enable fast-track construction thereby shortening time-to-market for new therapeutics and vaccines. The ExyCell facility is installed on the fourth floor of the ATLATL building located in the Zhangjiang High-Tech Park, and Miltenyi Biotec is now transferring production technology from Germany to China with regular operations for ATMP production is expected by autumn 2021. The facility will soon be open to visitors by appointment.

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BrainStorm Increases Commercial Manufacturing Capacity

BrainStorm Increases Commercial Manufacturing Capacity

BrainStorm Cell Therapeutics Inc., a leading developer of cellular therapies for neurodegenerative diseases, announced today that is has received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health for three state-of-the-art cleanrooms…

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WuXi Biologics Received Commercial Manufacturing License from German Health Authorities for its German Drug Product Facility

WuXi Biologics Received Commercial Manufacturing License from German Health Authorities for its German Drug Product Facility

WuXi Biologics (“WuXi Bio”) (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has received the License of Manufacturing Permit from German health authorities for its drug product facility (DP7) in Leverkusen, Germany. The permit successfully demonstrates for the first time that Premier Quality together with Record Speed WuXi Biologics consistently delivered in China can also be applied in global countries.

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Covalent Metrology Partners with Digital Surf to Bring Cutting-Edge Analytical Solutions to Instrument Users

Covalent Metrology Partners with Digital Surf to Bring Cutting-Edge Analytical Solutions to Instrument Users

Covalent Metrology, a leading analytical services provider offering one of the largest portfolios of characterization techniques in North America, is working with Digital Surf, a global leader in analytical software development, to offer software tools for data processing and visualization to its range of clients. The collaboration will also allow both companies to pool customer insights in the aim of providing better services and more powerful analysis tools.

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