OSD Trends

The importance of flexibility in OSD and ATMP facilities featured in Pharmaceutical Technology

Apr 6, 2020

CRB’s Dave DiProspero and Noel Maestre were interviewed for Pharmaceutical Technology’s article, “Building Better Manufacturing Facilities.”

Excerpt from PharmTech:

In adding manufacturing capacity—whether through new, greenfield sites or by refitting existing spaces—biopharma and pharma companies seek flexible and efficient production. Getting a facility up and running quickly with a tight budget is increasingly important.

Flexibility is crucial in biopharmaceutical manufacturing, because companies increasingly have multiple modalities (e.g., monoclonal antibodies, cell therapies, and gene therapies) in their pipelines. New biopharma facilities often use single-use technology, and modular buildings and systems are becoming more popular.

"Flexibility is important in oral solid dosage drug (OSD) manufacturing. Manufacturers are seeking to “right size” their operations and capacity based on their product portfolios and to upgrade processes, equipment, and technology for improved efficiency and faster product changeovers. Improving equipment and facilities for product containment and cleaning operations are other active areas in OSD." Dave DiProspero

ATMP Trends

The ATMP industry needs to be ready to go big with production—speed is crucial in biologics manufacturing. The rapidly growing market gives hope to people suffering from previously untreatable and rare diseases. But, to make that hope a reality, manufacturers must find a way to produce ATMPs quickly, efficiently and at scale.

And it’s best to start during the preclinical testing phase when you’re still flexible.

"The lack of automation that is currently common in the novel ATMP industry is changing. These novel therapies are quickly proving a need for process closure and automation, which in turn is driving equipment vendors to create and test novel equipment solutions." Noel Maestre

OSD Trends

In OSD manufacturing, facility layout is becoming more important as equipment and processes are moving toward greater integration.

"Continuous manufacturing and processes such as direct compression, which are growing in use, are examples of integrated systems, but integrating unit operations is also preferred in more traditional OSD processes. Modular and prefabricated construction is being used in OSD manufacturing. This type of construction is well suited for powder processing operations due to good cleanability, visual aesthetics, and the ability for use of glass to bring light into the spaces and provide for a user/operator-friendly working environment." Dave DiProspero

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