Wish List, Predictions for 2017

By Emil W. Ciurczak, Contributing Editor

A number of quite interesting events permeated the pharma world in 2016, leading me to make some predictions for the New Year.

Continuous Manufacturing (CM): This trend has been growing for several years, with some of the leaders submitting NDAs and some retrofitting batch processes to be continuous. I see a trend where contract manufacturing organizations (CMOs) will begin to add CM capabilities. Why? Simply stated, Big Pharma will outsource more and more functions and the core units are downsizing. This will be for a number of reasons, not the least being that the cost of goods sold is lower in developing countries than EU or U.S. locales (often a 4: or 5:1 ratio for salaries, alone).

Add to that the development time (to market) for CM is well over a year faster with as little as 10 percent of the cost of materials in a design of experiment. Throw in faster turnaround times of equipment and CM is looking quite attractive.

One predication is that long cleaning times will be reduced by “dry cleaning” the units. This could be accomplished (in a manner similar to cleaning a mortar and pestle with salt) by running a common excipient (e.g. lactose) through the system until the API cannot be detected, then beginning the following run and, possibly, discarding the first few tablets (determined by validation, of course).

THE RISE OF BIOSIMILARS
Biosimilars: For better or worse, there will be a spate of biosimilars introduced in the EU and U.S. While there will always be concerns about potential patent infringements and safety (possible long-term use of a “slightly” different molecule), the economic pressures in developed countries to lower the cost of medicines will, ultimately, win out over many other concerns. [Despite “difficulties” with generic manufacturers of small molecule drugs, the demand stays high for them.]

The Supreme Court is going to rule, assumedly, whether the 180-day delay on introducing a biosimilar copy of a “new biomaterial” will stand. Since each jurisdiction will need to balance science against cost burdens, many decisions are being awaited from the courts and agencies in 2017.

Counterfeiting of Drugs/Supply Chain Security: The cost (in money and safety) of counterfeit drug products is growing rapidly each year. If the products were simply generic “knock-offs,” the cost would merely be financial. Sadly, many are placebos (at best) and toxic (worst case) and adversely affect the health of the patient.

The “supply chain” element comes in when either the final product or a key ingredient is falsely sold as real. For example, a group from Leiden University and Coriolis Pharma found that sugars, used to stabilize large molecule APIs in formulation, can form nano and micro­scale particles. The sugars themselves contain nanometer sized particles, which can damage proteins and make drugs unsafe. These impurities could even trigger the immune system.

Newer and Smaller Instrumentation: If CM continues on pace, the instrument companies will do more than make current instruments “process-proof”; the designs will begin with CM in mind. That is, the hardware design will be performed with an eye to interfacing with controlling software packages and interfacing measurements with controllers. While PAT programs have done this for a decade, the impetus has mostly come from PAT programs at the pharma companies. Now, the instrument companies will take the lead and marketing to both generate their products and the concept of CM itself.

The “magic” combination of available hardware/software packages for CM will both legitimize and encourage the overall concept. As equipment becomes easily purchased, applications published and distributed, and instrument companies, themselves, become comfortable and proficient with the setting up of CM programs, they will become as commonplace as current manufacturing and analytical protocols… only the products will be made faster, better and for less money. A win-win-win scenario?