India and China represent nearly 40 percent of the world’s population, so their domestic markets for biologics alone represent a remarkable opportunity. However, currently, the opportunities for sales of biological therapeutics remain in more developed countries.

In the ongoing battle to cut costs while delivering quality and technically sound product, the biotech industry has spent the past two decades gradually moving toward single-use pre-sterilized plastic equipment for both clinical batch and, where applicable, production scale manufacturing. Single-use process equipment can be used and then disposed of, eliminating the development time to validate the sterilization and in-facility sterilization downtime, as well as development time to qualify and verify the cleaning and commensurate cleaning downtime.

Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve.

Inadequate communication between the consultant and the client, especially at the initial engagement phase, is often not taken seriously enough or addressed sufficiently on both sides.

We need to teach people how to think again. Then, we need to encourage them to think on a day-to-day basis so that they’re comfortable with it when a problem arises that requires out-of-the-box, beyond-the-SOP thinking.