Tech and Regulatory Issues? Biotech/Manufacturing Firms Discuss

In-Pharmatechnologist.com spoke to several companies at this year’s show in New York in order to assess the situation in the biotech industry at present. Companies including Pall Corporation, Baxter and Sartorius all gave their opinion on what the biggest technical problem was facing their industry today and whether any specific regulations were needed to address this.

There was some common ground amongst the companies, especially with regards to single-use technology. Vicas Gupta, from GE Healthcare told us that customers are looking “for complete single-use offerings from start to finish and most of the competitors in this space are striving to offer that complete portfolio.”​

This was backed by Helene Pora – VP of Single-Use Systems at Pall – who also described the issues of incorporating new single-use technologies when clients are looking at multiple products.

As for regulations, biomanufacturer Baxter spoke of its concerns that there were actually too many at present. Mico Holguin said:

“If anything we’re trying to find a way to work with the appropriate agencies to minimize the amount of regulations, especially the documentation required and the oversight.”​

ASI Life Science, however, was concerned that regulations did not currently cover standardisation in testing, whilst Sartorius focused on the present economic situation which had invited a number of smaller companies into the market, and thus regulatory bodies needed to check their materials, processes and documentation and “not look so much at the dollar sign.”​