Sustainably Manufactured Biopharmaceuticals

Biopharmaceuticals accounted for eight out of the top thirteen blockbuster drugs of 2021 by sales volume, accounting for 126.6B USD out 182.3B USD in global sales.  However, the sustainability of biopharmaceutical manufacturing is poor.  The cost of manufacture is high, with weak economic sustainability leading to increasing offshoring of manufacturing capacity.  Further, the complexity of current manufacturing processes, which drives these costs, makes biopharmaceuticals highly vulnerable to supply chain disruption.  The raw materials mass intensity of manufacture is high.  For example, monoclonal antibodies, a key class of biopharmaceutical, typically require more than 10,000 kg of raw materials to produce 1 kg of drug substance.  The vast majority of the raw materials need is accounted for by high-purity water, which is expensive to produce and whose sourcing in raw form may be a challenge for biotech hubs located in extreme drought areas such as California.  Directly associated with raw materials usage is waste generation, with waste mass intensities mirroring raw material waste intensities.  This leads to poor environmental sustainability.  The costs of biopharmaceuticals are high, leading to poor social sustainability, limiting both domestic and global access.  While manufacturing costs account for a small fraction of sales prices for biotherapeutics, e.g. for monoclonal antibodies the cost-of-goods for a drug product is typically 10-15% of the sales price, even selling a drug at cost puts these drugs out of reach for all but First World countries.  As the COVID-19 pandemic has painfully demonstrated for highly communicable diseases, it is not sufficient to manage domestic access alone.  And, of course, countries struggle to afford increasing drug costs.  Recognizing fundamental differences in purity requirements and scale, biopharmaceutical manufacturers can draw on technologies developed for industrial biomanufacturing to improve sustainability.