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CDSCO issues draft revised guidance on quality & safety documents for post approval changes in biological products

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) (..)

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Genezen to license CSL’s lentiviral vector production system

Pharmaceutical Technology

Contract development and manufacturing organisation Genezen has announced plans to license CSL’s Cytegrity lentivirus production system.

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Laurus Labs and IIT Kanpur partner for new gene therapy products

Pharmaceutical Technology

Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. Laurus Labs will be responsible for launching these products in India and emerging markets.

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How to successfully bring your drug product to launch

Bio Pharma Dive

Vetter brings a proven launch management process that combines extensive experience with in-depth product knowledge.

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Making the Case for Case Management for Cell and Gene Therapies

As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements.

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Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa

Pharmaceutical Technology

The now expanded agreement will enable Rubic to explore other therapeutic avenues in both the human and animal health product markets. The extension of the agreement beyond its original Covid-19 focus will accelerate development timelines, increase productivity, and lower manufacturing costs, according to Dyadic’s CEO Mark Emalfarb.

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Quality versus quantity in T-cell production: Why it doesn’t have to be a trade-off

Pharmaceutical Technology

In T-cell manufacturing, the historical issue of maintaining the quality of materials when scaling up production is changing.

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Commercial Drug Sourcing for Clinical Trials

Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight.