Continuous Manufacturing: Solution to Pharmaceutical Manufacturing Industry’s COVID-19 Concerns

The ongoing COVID-19 crisis has put the pharmaceutical manufacturing supply chain under close scrutiny. The overdependence of the US on China and India to meet its API demand has been the talk of the town. However, with the number of infected cases in the US surpassing that of China, the focus has shifted from discussing region-specific issues in the supply chain to, identifying technological solutions that can help address the challenges. According to the US FDA, advanced manufacturing technologies could help US-based drug production make up ground against China and other countries. One such technology that has been put forward as a potential solution is the adoption of continuous manufacturing.

What is Continuous Manufacturing

Continuous manufacturing, also known as continuous flow chemistry, is an advanced manufacturing technology, which drives operations in a continuous manner (24×7) in one facility, without hold times.  It is relatively cheaper to build and operate when compared to the traditional batch processes. Some of the key advantages are highlighted below:

1. Reduction in manufacturing cost (by 15-30%)
2. Reduction in manpower (by 50-70%)
3. Lower product deviation (by 50%)
4. Smaller footprint requirement (by 50-70%)
5. Reduction in power consumption (by 40%)
6. Faster scale up.

Moreover, the continuous processes use advanced sensors and in-process analytics that enable the measurement of critical parameters and processing conditions in real-time.

Adoption of Continuous Manufacturing

As per the interviews conducted with industry stakeholders, the industry is currently in the initial stages of adopting continuous manufacturing. However, the ongoing COVID-19 crisis is likely to accelerate the industry’s shift to these systems. In fact, a number of established big pharma players have already adopted these systems.

Since 2015, five orally administrable drugs, manufactured using the continuous technique, have been approved by the FDA; these are DAURISMO™ (Pfizer, 2018), SYMDEKO® (Vertex Pharmaceuticals, 2018), VERZENIO® (Eli Lilly, 2017), PREZISTA® (Johnson & Johnson, 2016) and ORKAMBI® (Vertex Pharmaceuticals, 2015).

Companies Offering Continuous Manufacturing

Presently, over 60 companies across the globe claim to offer manufacturing services using continuous manufacturing techniques. Over 60% of these companies offer services for API manufacturing, while only 37% offer drug product manufacturing services.

The majority of the companies that offer continuous manufacturing are currently based in the US and Europe. According to experts, academic research in this space is relatively stronger in the European region. In addition, Asia-Pacific is also witnessing some developments at the academic level.

Impact of COVID-19 on Pharmaceutical Manufacturing

Roots Analysis has put together a proprietary model taking into consideration several parameters to evaluate the impact of COVID-19 on the pharmaceutical manufacturing market. The parameters considered for the analysis include:

1. The breadth of the impact
2. Length of the impact
3. The capability of developers (in terms of cash flow and financial well-being)
4. Regulatory environment
5. Attitude towards outsourcing
6. Adoption of novel manufacturing technologies (such as continuous manufacturing)

To know more about the impact of COVID-19 on pharmaceutical manufacturing drop a note at rohit.kumar@rootsanalysis.com. Also, check out our report on continuous manufacturing to get a list of key players.

To identify the impact of COVID-19 on the gene therapy market, check out the blog here.