Continuous Processing: Is The Pharma Industry Finally Coming Round To The Idea? - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Continuous Processing: Is The Pharma Industry Finally Coming Round To The Idea?


Pharmaceutical Technology Europe
Volume 22, Issue 9

Q. PTE: From your experience, which areas of pharmaceutical processing have manufacturers chosen to convert to continuous processes as a priority? Why do you feel these processes have been prioritised and do you believe industry should readdress their priorities?

Nepveux (Pfizer): High volume, common unit operations — roller compaction, high-shear wet granulation, tablet coating, etc. — have been prioritised by manufacturers for continuous processing. I think the opportunity is in identifying unit operations where continuous processing is inherently better than batch in terms of product quality or functionality.

Schoeters (GEA): As we are a manufacturer of granulation, drying and tabletting equipment, we have of course seen the most activity in this field. Continuous processing technologies have proven popular for either new products or products that are suffering from batch-to-batch variability (quality issues), scale up-issues, manufacturing problems, all leading to high risks and cost implications. Having read literature and online discussions on the topic, it is clear that there are also big changes ahead in favour of continuous processing for primary pharmaceutical production.

Weiler (SAFC): Continuous flow chemistry is growing in favour amongst pharmaceutical manufacturers, particularly in more challenging manufacturing cases, such as:
  • Synthesis with changing product profiles – continuous processing allows much better control of reaction parameters, such as temperature, often achieving a more consistent product profile.
  • Processes with safety issues – the small reaction volume in continuous processes allows the running and scale-up of exothermic reactions that could not be run without special equipment or precautions in a batch process.
  • Thermally unstable intermediates – reactions can be scaled-up where thermally unstable intermediates are formed and continuously get converted into product.
  • Cryogenic reactions – Because of the excellent surface to volume ratio and the short reaction time, many continuous reactions can be performed with a better temperature control and higher reaction temperatures than in batch mode. There are several continuous reactions which can be continuously performed at 0 to 15 C where very low temperatures (-40 to -78 C) are required in batch mode.

Whitfield (Inprotech): Many pharma and chemical intermediates companies have seriously considered continuous processing for the manufacture of small molecule APIs and several have successfully implemented such technologies for certain unit operations, including mixing, reaction and crystallisation. However, a fully integrated continuous processing system, for all the typically required unit operations, has yet to be industrialised, as far as I am able to ascertain. More recently several pharma (ethical and generic) companies have invested in dry or wet granulation and drying continuous processing systems. However, secondary manufacturing is playing catch-up, as drug product continuous processing is not as exploited as it is for drug substance manufacturing.

There are tremendous benefits that can be realised through the adoption of continuous processing for APIs, including greatly improved mixing and chemistry; increased yields, efficiencies and process safety, which are largely born out of the vastly superior process control capabilities. Moving to micro or meso scale systems hugely impacts on the factory footprint requirements, delivering significant capital savings for new build projects but not so beneficial for retrofits, which are more common in the industry right now.

Similarly for secondary continuous processing applications, improved process control, greater utilisation of equipment, floor space and resources, delivers unquestionable operational cost benefits. There is clearly now a move more towards the application of continuous processing for drug product manufacturing and some companies are even developing a fully integrated primary and secondary manufacturing capability. I believe this is ultimately the right approach to maximise the holistic benefits of continuous processing.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology Europe,
Click here