Talking to investors on a first quarter results conference call in mid-April, Joachim Kreuzburg, CEO of Sartorius, discussed whether COVID-19-related demand was at its peak. Kreuzburg estimated that the annual run rate was up to 5bn vaccines a year, leading him to argue that demand is at least close to its peak.
“I do not believe it would be realistic to assume much more demand going forward,” said Kreuzburg. Second-generation vaccines and booster shots will create continued demand but the period in which billions of people need two doses will be finite.
Providers of bioprocessing equipment are now preparing for the potential tailing off of demand for products used in the production of COVID-19 vaccines and therapeutics. Even so, the expectation of continued growth in the capacity requirements for monoclonal antibodies and other biologics used against diseases beyond COVID-19 is spurring bioprocessing businesses to keep investing.
Avantor, for example, is investing in its ability to make single-use bioprocessing equipment. Demand for Avantor’s single-use products, which has grown at upward of 20% in recent years, accelerated as COVID-19 vaccine production ramped up.
Faced with the effect of COVID-19 on demand, Avantor accelerated its investment plan, expanding its existing facilities and adding a second site in Europe. Avantor is confident there is demand to sustain its expanded footprint.
“It really is necessary to keep up with the growth as well as establish more normal lead times for our base business and for our offerings to put the capacity in place. So the capacity will be realised pretty much instantaneously,” said Avantor CEO Michael Stubblefield on a quarterly results conference call at the end of April.
Bioprocessing investment activity currently skews toward batch production, reflecting the market. While a handful of small molecule products are now made using continuous processes, the batch approach retains a tight grip on the biologics sector.
Work to support the application of continuous processes to commercial biologics is underway. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use is this year set to hold a public consultation on ICH Q13, its planned guidance on the continuous manufacturing of drug substances and drug products.
The guideline will cover both small molecules and therapeutic proteins. As it stands, antibodies are the focus of research into the application of continuous approaches to biologics but the ICH is using the term “therapeutic proteins” to avoid excluding other modalities.
