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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. Published May 2012. 4 The International Pharmaceutical Excipients Council (IPEC). Published 2008.

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Top 20 RNAi Therapeutic Companies Based on 2022 R&D Expenditure

PharmaShots

Founded Year: 2012 Total Employees: ~190 Headquarters: California, United States Market Cap: $1.2B The company strives to discover and develop therapeutic products under its business segments, including General Medicines, Specialty Medicines, and Vaccines. Aligos is developing ALG‑125755 under its oligonucleotide platform.

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Contamination Trends & Proposed Solutions

ISPE

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

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Health literacy needs support, now more than ever

pharmaphorum

According to the 2012 European Health Literacy Survey , 29% to 62% of people across eight EU member states had inadequate or problematic health literacy. Those steps were followed in October with a new global policy that banned any adverts that would discourage people from getting vaccinated, whether for COVID, the flu or anything else. “We

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