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What gene therapy manufacturers can gain from collaboration

European Pharmaceutical Review

In recent years, the biopharmaceutical industry has found itself at a crossroads – being able to offer advanced and truly innovative treatments, such as gene therapies, but facing the complex challenge of creating manufacturing standards for the biotechnology sector from the ground up.

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift.

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Forward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control with high-performance analytical instrumentation

European Pharmaceutical Review

API method development and testing at Polpharma API As a key player in the Polish pharmaceutical market and a prominent drug manufacturer in Central and Eastern Europe, Polpharma API exports medicinal products to 35 markets and active pharmaceutical ingredients (APIs) to over 60 countries.

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Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 1 Following in vitro production from T cells collected from a patient’s leukapheresis procedure, the CAR T cells are infused back into the patient’s blood, where they proliferate and expand.

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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

Additionally, the authors highlighted that a greater number of pharmaceutical and biotechnology contract manufacturing organisations (CMOs) has broadened the opportunities for providers of pyrogen testing services. This was attributed to their “highly sensitive and specific” testing capabilities.

Safety 94
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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” One case of drug contamination from 2021 was highlighted in the paper.

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Economics and risks of FDA’s Quality management maturity rating programme

European Pharmaceutical Review

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.