Ahead of a special Continuous manufacturing session at CPHI Frankfurt, Bikash Chatterjee (BC), CEO at Pharmatech Associates speak exclusively to Chemicals Knowledge Hub (CKH) on how the sector will revolutionize pharma manufacturing – and what might be ahead, looking 10-years into the future. The session entitled “Broader Adoption of Continuous Manufacturing – Tackling the Difficult Problems” will explore the barriers we have to address, to enable the industry its full potential. Lawrence De Belder from Pharmatech Associates will discuss insights on aligning industry, academia, and regulators. The session will be held on Nov 2^nd 2022 from 4:05pm – 4:30pm.

CKH: Continuous manufacturing is still very limited, how many CDMOs do you see being invested in continuous manufacturing in 3, 5 or 10 years?  

BC: “While today there are a handful, I see CDMOs growing slowly and steadily as the pharma industry adopts continuous manufacturing. The challenge for CDMOs with continuous manufacturing is that the processing is somewhat tailored to the formulation. Hence CDMOs can invest in equipment for platform processes such as direct compression but must understand there is no true one size fits all. The cost-saving and efficiency advantages of continuous manufacturing are attractive so I would look for most major CDMOs in the major markets in the U.S. and EU to invest in basic capabilities in the next decade with smaller markets lagging in their adoption. If I were to speculate on the number of CDMOs investing in continuous manufacturing, I would see <1% in the next three years, 3-5% in the next five years, and 5-10% in 10 year’ time would have some continuous capability for the major markets.”

CKH: By when do you think CDMOs would have to be invested in continuous manufacturing  to not be left behind?

BC: Over the next five years, as the regulatory and operational benefits become more broadly known and realized in industry, CDMOs will have to build continuous manufacturing capability and expertise to remain competitive.

CKH: What do you see as a next development of continuous manufacturing, next steps?

BC: “The are several evolutionary stages ahead that will make continuous manufacturing more broadly adopted. Look for equipment designs to become more robust focusing on standardization of PAT technology (Process analytical Technology) and addressing the challenges with cleaning and change over. Look to PAT technology to become more robust and for comparability strategies become part of all vendors playbook. Look for more evolved data and control management software solutions to be available in the marketplace to address the basic compliance requirements as defined by ICH.”

CKH: Do you think FDA/EMA will move to disincentivising batch manufacturing in the next 3-5 years, i.e., slower approvals for batch? Or not?

BC: “I think both health authorities have invested in shifting to a regulatory review process based upon science. continuous manufacturing lends itself to this philosophy. I do see continuous manufacturing submissions having the advantage of greater characterization and control leading to fewer questions and faster approvals.”

CKH: Do you think continuous manufacturing will be used in API or Biologics or Finished products manufacturing? If so, can you put a timeline to that, for each?

BC: “Continuous manufacturing has a been used in API manufacturing for nearly 50 years. Still, there are some reactions that cannot be done safely with anything but a flow reactor.  To date, there have been 11 finished drug products approved that were based on continuous manufacturing and I would look for that number to increase. Biologics are considering continuous manufacturing but as a hybrid solution in which upstream or downstream may be operated independently applying continuous principles. As PAT sensor technology continues to improve look for the industry to leverage continuous manufacturing to maximum benefit.”

CKH: Can you give a geographical context to continuous manufacturing? Which region or countries do you think will invest in continuous manufacturing first?

BC: “In the U.S., large pharma and biotech are leading the continuous manufacturing charge with concentrations on both coasts. Europe, especially Germany, has the most advanced equipment vendors driving innovation to address the needs of continuous manufacturing.”

CKH: CPHI conducted a global survey among 400 pharma executives and over 93% think we will see an approval for either of these two drugs, with 70% predicting it inside the next 3-years. Looking 8-10 years out, the industry believes five therapies (average answer) will be approved.  Do you have any thoughts on the data?

BC: “I do not think the FDA will approve a psychedelic in the next decade because most of these are classified as schedule 1 drugs, which are drugs that have no therapeutic benefit. DEA is notoriously conservative in changing their designations unless there is an overwhelming need to address. We have seen this with marijuana and CBD-based therapies today. Getting two federal agencies to collaborate and coordinate their programs is not quick and easy.”