Challenging the economies of scale in mAB production

Demand for vaccines and biosimilars is increasing all the time*. So how come biomanufacturing is talking about overcapacity instead of struggling to keep up? Answer: As upstream titer yields are now so high, there's no need for all that capacity in purification; in fact, many plants are already running well below full throughput. And since the trend towards personalized medicines means a larger number of smaller batches, there will be even fewer lucrative production runs in future too.

So how do you make downstream processing smarter, faster and more cost-effective? Firstly, by adapting and streamlining existing plants and processes. On the hardware side that means smaller plants, smaller reactors, inline dilution, and widespread use of dispos- ables; on the process side, many manufacturers are trying to reduce the total number of purification steps – and are placing even greater emphasis on quality from the outset.

The second way to reduce purification costs is by switching to products that cost less than conventional chromatographic media, yet perform far better. Since the latest high-tech resins can boost the binding capacity for target biomolecules by up to fifty percent, they're ideal for downstream processors who want their budgets to be smaller and smarter too.

*Sales development 2009–2010: Vaccines: India + 39%, Japan + 31%, China + 20%. Biosimilars: USA + 50%

In This Same Issue:

• Our all-round approach to high-productivity downstream purification
• Growing together: Merck and the Chinese market leader for cell culture media
• Why does Merck have more than one EMPROVE® portfolio?
• Merck hosts the first Rx-360 Consortium global open day meeting