In his final act as Director of Pharma Solids Sales at GEA Pharma and Healthcare, Richard Steiner, reflects on another record-breaking year for the company’s ConsiGma® 4.0 continuous manufacturing product line for the pharmaceutical industry.  

GEA’s flagship CDC (continuous direct compression) series gained further ground in the market this year as many top-tier pharmaceutical companies adopt and implement continuous manufacturing (CM) lines. Benefits such as high levels of overall equipment effectiveness (OEE), containment, ergonomics and, most importantly, easy product transfer are driving the uptake of CM solutions amongst both ethical and generic oral solid dosage form producers, as well as CDMOs. Whether it’s for new chemical entities (NCEs) or established products, low volume/high value and/or high volume/lower cost drugs, #GoingConti is paving the way to a sustainable future in pharmaceutical manufacturing.

In the CDMO space, it’s becoming increasingly well recognized that tier two and three organizations also need a continuous processing platform to roll out their NCEs — from early stage development to clinical supply and into the market. It’s an even faster process — with less financial burden — for those who don’t actually own any manufacturing equipment in the first place.

It’s the same story for generics manufacturers who are also looking for lean applications and higher efficiencies. Chinoin from Mexico, for example, recently discussed the advantages of applying CM technologies to drive operational excellence and, even more importantly, ensure higher levels of quality for patients at ACHEMA 2022 (click here to see the recording of this event).

Regulatory Affairs
More than ever, owing to the current macro-economic situation, more scalable and reliable process technologies are gaining regulatory oversight … and approval. In the bow wave of this success, the GEA Coater — as well as ConsiGma® 4.0 material handling solutions — have found a niche as both integrated solutions and standalone units.

Linked to a GEA compression machine, the coater product line is also being used in small-volume oncology applications as a “step-by-step” route to implementing CM. The precision coating aspect with containment and “scale-out” potential was a deal breaker in this so-called “mini batch regime.”

Other interested parties include raw material suppliers such as BASF, Colorcon, DFE, Dow and Evonik — to name just a few — who are contributing to the adoption of CM by bringing new excipients and ingredients to the pharmaceutical market that have been specifically developed for continuous processes. Even beyond the drug product sector, we are seeing more and more examples of continuous processes being successfully used on drug substances and biologics.

Last but not least, sustainability imperatives are influencing the decision-making process when it comes to implementing CM lines. Advantages include much smaller footprints, utility savings, high throughputs and operator safety, as well as the fast deployment of assets and “zero waste” production.

Conclusion
The GEA team can happily report the growing interest in CM throughout the global pharma industry, even in “pharmerging” regions. From CDMOs to OTC companies and from ethical products to generics, forward-thinking innovators are investing in continuous processing to drive operational excellence and remain competitive in both regional and global markets. Beyond remaining agile and sustainable, and able to navigate the uncertainties that lie ahead for the pharmaceutical industry, the application of CM is now recognized as a better way to deliver safe and cost-effective drugs to patients.

Current market trends suggest a bright future for CM applications and support the need for pharmaceutical companies to further invest in advanced manufacturing technologies such as continuous processing. During the last 20 years, the modular ConsiGma® 4.0 line has consistently enabled operators to free up additional productivity reserves and contribute to operational excellence.

#GoingConti might still be on the horizon for some, but the momentum is increasing. Driven by macro-economic factors and the global trade situation, even the highly regulated pharma industry must heed the call for “leaner and cleaner” development and manufacturing processes. The time has come for the safer, affordable, more reliable and sustainable supply of pharmaceuticals.