Increase your supply chain’s flexibility.
Reduce the total cost of supply. Maintain your high standards
of quality control.
Patheon pharma services, offers continuous manufacturing as a new paradigm in the supply of oral solid dose products
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Why continuous manufacturing?
Simply put, it can deliver high quality oral solid dose products, with greater flexibility and at a reduced cost of supply.
Is continuous manufacturing the right fit for my product?
Development programs with one or more of the following characteristics are likely to benefit from the value of continuous manufacturing:
Continuous
From decreased costs to increased agility, see the results across all areas of your process
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Minimize API requirements during development
Shorten Development Timeline
Improve quality and consistency of products
Respond to changes in market demand
Reduce total cost of supply
Process development studies are smaller and require less API, and scale-up studies are not required.
Process development can be done quickly as multiple parameters can be tested at the commercial scale in a single run.
The state of control achieved by the automated process results in the production of a consistent, high-quality product.
The flexibility of the process allows for a quick reaction to an upsurge in product demand, reducing shortage risks.
Achieve total cost of
supply benefits as a result of increased speed to clinic or market, lower cost of quality, elimination of scale-up activities, reduction of API use, and reduction of inventory due to flexible batch sizes.
See how continuous manufacturing can streamline your process
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Manufacturing benefits
Learn more about how continuous manufacturing could change the way you process oral solid dose drugs
Frequently asked questions
Hover over cards to see answers
01
Why isn’t continuous manufacturing suitable for early phase products?
02
How have you been able to get the total cost of supply to be lower than batch produced products? I thought new technologies would be expensive.
03
How is quality assurance improved with continuous manufacturing?
04
Can QbD be used with continuous manufacturing?
05
How is the supply chain more flexible with continuous manufacturing?
06
How can we get to market quicker using continuous manufacturing?
07
Why is the FDA (and other regulatory authorities) in favor of continuous manufacturing?
It isn’t that continuous is not suitable for early phase — rather the small production volumes usually associated with early development means
small-batch development work is the most efficient approach.
Total cost of supply benefits come through multiple value drivers including increased speed to clinic or market, lower cost of quality, elimination of scale up activities reduces API use, and flexible batch sizes reduces inventory or shortage risk.
Continuous process feedback through the highly automated process allows for real-time monitoring, adjustment and feedback to assure quality.
Absolutely. In fact, the data-rich environment aligns very well with the FDA’s guidance on QbD and provides an array of tools for Continuous Process Validation, which are less common in the batch paradigm.
With continuous manufacturing,
drug product quantities are varied by changing the duration of the manufacturing process, rather than adding or removing batches in a busy schedule.
Time savings are achieved as there are no scale-up activities. Programs are developed, launched and commercially manufactured on the same equipment train with the process just being run at different lengths of time to meet volume requirements.
The data package and the improved assurance of supply have driven the FDA and EMA to support continuous manufacturing adoption.
High total API cost
$
Aggressive clinical timelines
Scalability risk in batch processes
High to medium annual volume (50M – 1B)
High forecast variability due to launch or generic competition
Lifecycle management
Supply chain risk within current manufacturing strategy
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Low volume products (<50M units per year) will have a similar total cost of supply as a batch process and will benefit from the consistently high-quality product output with a continuous process
08
Will it cost me a lot to determine if my product is suitable for continuous manufacturing?
09
What if the development studies show that my product isn’t suitable for continuous manufacturing? Have I just wasted money on these studies?
The cost of determining suitability is minimal and reduces the level of work required for a technology transfer or full blown development program.
No. The data created as part of the suitability work can be leveraged to better understand the material characteristics of your program and can be helpful in batch development and scale up.
