Biopharmaceutical

Attention is widely focused on COVID-19 vaccine manufacturing and supply chains. The upswing in demand is expected to generate bottlenecks in areas such as filling and distribution. Other supply chains concerns include ultra-low temperature transport and storage, glass-vial shortages, and insufficient amounts of carbon dioxide to make dry ice. As for production, Adrian La Porta of Bryden Wood believes that global supply of vaccines may be delayed by lack of available personnel worldwide with the necessary expertise.

Pfizer manufactures its COVID-19 vaccine internally, with three separate US manufacturing sites focused on raw materials, mRNA drug substance production, and formulation, fill and finish. Outside the US, in Germany, BioNTech, Pfizer's partner, is manufacturing raw materials, with German contract manufacturing Rentschler providing purification and Pfizer's own site in Belgium performing formulation and vial filling. Additional European suppliers in Germany and Austria are providing lipids and excipients.

Moderna is utilizing contract manufacturers for its vaccine production, including Lonza facilities in the US and Switzerland, using a three-step process. CordenPharma is supplying lipids, drawing on facilities in France, Switzerland and the US. US-based Catalant and Spain-based ROVI are supplying fill and finish services.

Although AstraZeneca has not disclosed its manufacturing suppliers or partners, it has noted that it's using multiple supply chains and facilities encompassing over 20 partners across 15 countries.

As more is learned about the vaccine, it is likely that production volumes and processes will be further finetuned and greater efficiencies will take hold. Yet such changes may threaten the vaccine's regulatory status. But if a regular supply of vaccines is necessary, such as annual vaccination, greater efficiencies could be necessary.

Source: The Chemical Engineer (December 10)

Chemicals

Excluding pharmaceuticals, US chemical production is expected to bounce back next year following an estimated 3.6% decline in 2020, according to the American Chemistry Council's (ACC's) "Year-end 2020 Chemical Industry Situation and Outlook." In 2021, production should rise 3.9% with a 2.7% rise forecast for 2022. Production in all chemical segments fell this year, except plastic resins due to COVID-19-related demand.

Among the declines was production basic chemicals, which dropped 1.3% with all segments showing declines. However, in 2021 and 2022, basic chemicals production is expected to grow 5.0% and 3.2%, respectively, as the economy recovers and industrial production, such as automotive manufacturing and building and construction, returns to growth. In 2020 US industrial production fell 6.9% but should rise 3.7% next year and 3.5% in 2022.

US chemicals trade declined 7% in 2020 to $220.8 billion, with exports down 9% to $124.0 billion and imports down 5% to $96.8 billion. However, in 2021, they should recover to $134.5 billion and 105.5 billion, respectively.

Source: ACC (December 9)

Food

Amazon has announced that it will begin requiring vitamin and supplement manufactures test their products sold on its site that have no nutrition fact panel. Companies must provide a Certificate of Analysis (COA). Among the requirements are labels reflecting the actual potency and amount of active ingredient and that the products are produced using GMP.

Supplement maker NOW, which documents its product testing result, has publicized its potency test results of other companies' supplement products bought on Amazon. The findings showed the amounts of the active ingredient did not meet label claims in most cases. Although Dan Richard, vice president of sales at NOW, is glad about Amazon's new policy, he observes that COAs can still be manipulated and that Amazon personnel may not have to the expertise to properly analyze them.

Source: nutraingredients-usa.com (December 4)