BioPharm International-12-01-2019

The innovative spirit of biotech startups is a driving force behind the development of new therapeutic products, but building a successful biopharmaceutical company from the ground up has its risks and challenges.

Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting materials, and they must ensure a steady supply.

Nearly four decades after the first diagnosis, the fight to treat HIV/AIDs continues.

Ensuring that viral vectors are free of viral contaminants requires a focus on prevention and control.

Investigating deviations or failures of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished

Problems in assuring reliable drug quality and supply dampens progress in bringing lifesaving therapies to market.

Downstream process development and manufacturing play a crucial role to ensure safety, quality, identity, purity, and efficacy.

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