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12 Apr 2023

Bioformulators Should Consider 3D Printing

Researchers behind a novel, non-injectable version of infliximab say 3D printing could help biopharmaceutical manufacturers overcome the formulation challenges associated with large molecule drugs.In
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04 Apr 2023

Bioprocesses at risk from proposed ‘forever chemicals’ regulations

Experts are calling on industry to respond to proposed rules restricting perfluoropolymers – commonly considered ‘forever chemicals’ – which are used in virtually all biomanufacturing processes.The Eu
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30 Mar 2023

EMA’s quality innovation group helps to propel regulatory path for novel technologies

BASEL, Switzerland – The European Medicines Agency’s (EMA) newly formed Quality Innovation Group (QIG) aims to clarify regulatory expectations for innovative manufacturing technologies to help bring t
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22 Mar 2023

Drug shortages are rising and pose a national security risk, new report warns

WASHINGTON — Children's medication, antibiotics and treatment for ADHD are among a number of drugs that have been in short supply in recent months — and the shortages of critical medications are only
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10 Mar 2023

GAO to FDA: Do more to encourage drug manufacturing innovation

The Government Accountability Office on Friday released a report calling on the FDA to better encourage the adoption of advanced drug manufacturing practices, particularly as interviews with 15 stakeh
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02 Mar 2023

FDA issues continuous manufacturing advice to build an agile pharma industry

On 1 March, the FDA issued the International Council for Harmonisation (ICH) final guidance on the use of continuous manufacturing in drug production. This publication marks the FDA’s proactive
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21 Feb 2023

Asia-Pacific Roundup: Pakistan finalizes GMP guidelines

The Drug Regulatory Authority of Pakistan (DRAP) has finalized its first set of consolidated guidelines on good manufacturing practices (GMP), overhauling a section on quality control since releasing
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08 Feb 2023

USP Proposes to Add Flexibility in the Selection of Parenteral Packaging

To help address concerns about the supply of glass vials, the USP intends to revise the packaging and storage statements in several USP monographs for parenteral products which currently prescribe a s
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21 Nov 2015

Aseptic Packaging Market Worth $62.46 Billion by 2020

The global aseptic packaging market is projected to be valued at around $62.46 Billion by 2020, growing at a CAGR of 10.66% from 2015. Availability of improved equipment & technologies and emergen
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