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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Tell us about Ocugen’s lead programme, OCU400. Unlike conventional methods…modifier gene therapy…emphasises the importance of the broader biological system, potentially leading to more effective treatments.” What are the top three challenges associated with gene therapy manufacturing?

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European authorities recognised for leading medicine regulatory oversight

European Pharmaceutical Review

The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.

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World-first medicine manufacturing regulatory framework to be implemented

European Pharmaceutical Review

The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA). Products manufactured at the point of care are eligible for the MHRA ILAP pathway.

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Hospitals and Medical Device Manufacturers Must Work Together on Cybersecurity

MedCity News

Greater collaboration among healthcare providers, medical device manufacturers, and lawmakers and regulators will lead to predictability and consistency in cybersecurity management. Together, we can make even greater strides toward patient safety and a more secure and sustainable healthcare system.

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Hetero Labs Limited-Walk-In Interviews for EHS- Process Safety Management/ Process Safety Lab On 24th Sept’ 2022

Pharma Pathway

Hetero Labs Limited-Walk-In Interviews for EHS- Process Safety Management/ Process Safety Lab On 24th Sept’ 2022. HETERO is one of the India’s leading generic pharmaceutical companies and is one of the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS. Job Description. Greetings from Hetero…!!

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Why is microbiological testing in medical device manufacturing important?

European Pharmaceutical Review

This approach can also help determine the appropriate manufacturing processes, sterilisation methods, and maintenance procedures. However, the safety and efficacy of these devices can be compromised if they are not appropriately designed, manufactured, and maintained, the authors wrote. Sharma et al. Sharma et al.

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Advancing environmental monitoring systems for CGT manufacturing

European Pharmaceutical Review

The introduction of rapid microbiological testing methods, such as biofluorescent particle counters for real time detection of microbial contamination, has had an important impact on cell and gene therapy manufacturing. Environmental Monitoring In-Depth Focus 2024 How is eXmoor navigating these advances in the sector? What were the solution?