The continuous method is greatly impacting the solid dosage drug industry, L.B. Bohle’s manager of scientific operations Robin Meier told us in the lead up to his talk at Interphex this week.
Continuous manufacturing (CM) offers a variety of benefits to drugmakers he told us, such as improved product quality and reduced costs.
Some companies focus on the reduced outlays assocatied with the continuous – as opposed to batch – method, such as reducing good manufacturing practice (GMP) areas, transport, storage, and active pharmaceutical ingredients (APIs) during R&D phases, said Meier.
“Others see the huge flexibility as an important point, which may facilitate a shorter time to market and the possibility to flexibly respond to changing market demands during the lifecycle of a product,” he told us.
CM can also reduce the amount of contact operators have with intermediate products, which can reduce health and safety risks in the facility, he added.
The right mindset?
When making the switch from batch manufacturing to CM, Meier highlighted the need for companies to adopt a unified approach.
“There is not only the production department involved [when adopting CM technologies], but R&D, QA/QC, regulatory affairs, management…almost all departments are involved.
“For all players, the adoption of CM processes [involves] changes in work – and mindsets,” he told us.
Accordingly, employers and staff must learn quality-by-design principles and increase knowledge in specific processing fields.
“Managers and investors must also be convinced [of the CM method] in order to approve payment for continuous technologies,” he said.
Initial costs are higher than batch technology, but the return on investment will come at a later date, both in terms of cost and quality, he added.
Who is on board?
Meier told us every company L.B. Bohle deals with is talking and thinking about CM.
Most larger players have already adopted continuous manufacturing technology, while others might be in early stage discussions, or have at least created dedicated departments charged with implementing the method, he explained.
L.B. Bohle offers CM equipment, including continuous direct compression, continuous roll-compaction and continuous wet granulation/drying technology.
The vendor will be presenting a new machine for continuous granulation at Interphex, which it says is the first ‘truly continuous’ drying technology for R&D on the market.