OEB Level-5 is the highest occupational safety classification in pharmaceutical manufacturing. It is required for cytotoxic oncology APIs and HPAPI compounds where airborne worker exposure must stay below 1 microgram per cubic metre of air. A genuinely certified facility needs ...

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For most pharma companies, a CDMO partnership is significantly cheaper than building in-house. An in-house oncology manufacturing facility costs USD 150M–500M+ to build, takes 3–5 years to reach the first commercial batch, and carries full utilisation risk on your balance ...

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To select the right oncology CDMO, evaluate seven criteria in this order: regulatory approvals (USFDA, MHRA, EU-GMP, ANVISA), OEB Level-5 containment certification, end-to-end oncology services, technology transfer track record, manufacturing capacity, BIOSECURE Act supply chain compliance, and quality culture. Always ...

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There is a question every pharma company building an oncology pipeline eventually has to answer honestly: do we build this manufacturing capability ourselves, or do we find someone who already has it? Building it yourself means years of facility construction, ...

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Walk into a hospital pharmacy in Nairobi, São Paulo, or Warsaw and pick up a generic oncology drug. Odds are better than most people realize that it was made in India. Not because India got lucky in the pharmaceutical race, ...

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There is a question that comes up on almost every procurement call in the pharmaceutical industry, particularly when a company is entering a new market or scaling an oncology program: are we looking for a CMO or a CDMO? The ...

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Keeping the quality high and adhering to standards that are safe for patients isn't a goal but a responsibility in the pharmaceutical industry. As medicines and health supplements are used by millions of people every day, even the smallest error ...

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Among many challenges in the pharmaceutical world, the biggest is ensuring the maintenance of medication quality and availability for patients whenever they need them. Drug shortages, delays in supply, and manufacturing disruptions can impact patients' health. Addressing these challenges, many ...

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The developments in modern medicine and the pharma sector have made great progress in treating complex and chronic diseases. Although many treatments still come with challenges such as strong side effects, complicated dosing schedules, and difficulty in maintaining consistent drug ...

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The rapid evolution in the pharmaceutical sector has made drug development more complex, with shorter timelines and high-end regulatory expectations worldwide. In that strict environment, many pharma companies are increasing their reliance on external partners for drug manufacturing. This is ...

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