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Quality by design with a focus on biosimilars

Pharmaceutical Technology

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. There are many variabilities with biosimilars and the brand name protein drug.”

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Indian pharma manufacturing: rising investment in Andhra Pradesh

Pharmaceutical Technology

The southern states Andhra Pradesh and Telangana house almost a quarter of India’s contract manufacturing facilities; their sites supplying medicines to the US and EU have grown robustly over the last four years. US reliance on India for generic drugs could have supply chain security and quality implications for critical medicines.

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Scientists engineer safe, virus-resistant E coli for research

Drug Discovery World

The work promises to reduce the threats of viral contamination when harnessing bacteria to produce medicines such as insulin as well as other useful substances, such as biofuels. coli to make all their life-sustaining proteins from 61 sets of genetic building blocks, or codons, instead of the naturally occurring 64.

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HPAPIs – Current Interest of the Pharmaceutical Industry

Roots Analysis

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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Top tweets: Covid-19 headed towards seasonality – and more

Pharmaceutical Technology

Peter Hotez, a vaccine scientist and professor and dean at the National School of Tropical Medicine at the Baylor College of Medicine (BCM), shared an article on the Seattle biotech company, PAI Life Sciences having launched a trial for the tropical disease schistosomiasis.

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As FDA inspections return, upholding compliance and maintaining GMP readiness is more crucial than ever

pharmaphorum

If businesses have received a notice of inspection, they should focus on two key things: Adulteration: proof there is no chemical, microbial, viral, or other type of contamination in products. in structural characterization of medicinal products and an MBA in management. However, we understand that this is not always possible.

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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Recombinant therapeutic proteins. Fusion proteins. Gene and cellular therapies. Growth factors. Interferons.