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How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?
The pharmaceutical industry’s future will be driven, for all intents and purposes, by the technological evolution emerging now. But with a reputation for being slow to adopt any type of change to the industry, how quickly or slowly will pharma embrace these emerging technologies? These are questions posed by Emil Ciurczak, Doramaxx Consulting and CPhI expert panel member, in the CPhI Annual Industry Report 2017.
Because any concept or production technology/monitoring process that was “new” was typically time-consuming and costly to implement, pharma manufacturers historically opted for the conservative route, which meant retaining decades-old manufacturing technology and ideas over adopting the new. This is one reason for the industry’s general resistance to the idea of process analytical technology (PAT), for which FDA published a guidance in 2004, Ciurczak noted in the report, using PAT as a current example of the industry’s slowness in accepting and implementing new concepts and technologies.
“If PAT is used to merely assay the old-fashioned method of production, its main outcome will be discovering all the weak points and outliers [in the production process]. But can/should PAT (and QbD [quality by design]) be used to speed up AND improve the quality of the product?,” he said in the report.
Among the technologies and concepts that Ciurczak sees as being game changers in pharma are PAT and QbD, continuous manufacturing, and 3-D printing.
The idea of PAT is not actually new, going back 15 or so years, according to Ciurczak. It is still an idea worth adopting, however, even if a company is heavily invested in traditional batch-type manufacturing. PAT can help in several ways, he noted in the report.
Adopting PAT into QbD can promote qualitative examination of incoming raw materials, both excipients and APIs. By having the parameters of the raw materials measured, operators will be allowed to estimate mixing times as well as validate the quality of raw materials early in the process, which can save time in the long run when validating downstream drug substance in the quality control lab.
Another aspect of PAT-putting in an in-line, real-time blend uniformity unit-would allow for optimal mixing time and can eliminate overmixing, which can then shave off minutes in processing each lot of product. This would be an example of adding equipment without adding cost, according to Ciurczak. Furthermore, having active monitors at each production step fulfills a GMP requirement that calls for having “meaningful in-process tests.” “Not only will these data be meaningful, but obtained in a timely fashion, potentially avoiding lot failure,” said Ciurczak in the report.
In the report, Ciurczak also advocates the use of continuous manufacturing (CM), noting that there are already several large pharmaceutical companies, including Pfizer and Vertex Pharmaceuticals, that are engaging in CM as well as several more companies that are working on the technology needed for CM.
There are several advantages in using CM in lieu of batch production, he asserted in the report. These advantages include: the ability to run full-sized batches in a shorter amount of time and having all the analytical data available at the end of the run; no wait time for lay results, as the whole batch would have been monitored and analyzed in real-time; easier and efficient cleaning that can cut downtime between products; and a smaller footprint because an entire CM suite may be housed in a two-story room.
3-D printing (3-DP) is another revolutionary technology that can benefit the pharmaceutical industry. Although it is not likely to immediately replace products that are either easily produced or are made in large numbers, this methodology answers a number of complicated questions, Ciurczak stated. Special delivery systems-such as osmotic pumps-and even long-duration (i.e., controlled-release) dosage forms benefit from 3-DP, which gives a more reproducible dosage form than any other system, he said in the report.
Other benefits that can be realized with 3-DP include simpler cleaning; the ability to produce smaller experimental units, which can be important when the unit is complex and/or the API is rare or expensive; and the potential for lower-priced units.
Source: CPhI Annual Report 2017