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Upgrades from clinical phase to commercial grade
July 26, 2013
By: Tim Wright
Editor-in-Chief, Contract Pharma
Piramal’s Healthcare unit will invest $2.5 million at its FDA-approved Grangemouth, UK, site to upgrade one of its antibody drug conjugate (ADC) manufacturing suites from clinical phase to commercial grade. The expansion will provide two commercial grade ADC suites at the facility, while retaining clinical phase manufacturing capacity in other suites on site. Piramal also plans to expand its Proof of Concept (POC) offering at the site for pharma companies looking to demonstrate antibody and/or toxin suitability for use as an ADC. The batch size offered from the Grangemouth facility ranges from 1-1.5 kg and the company has capacity for further expansion on site if required. As part of the investment, the areas supporting the manufacturing suite will also be upgraded to provide new areas for buffer preparation, equipment preparation and antibody freeze/thaw. “Piramal was a pioneer when it came to the commercial manufacture of ADCs,” said Aidan Walker, president of Formulation Services at Piramal. “Continued growth in the ADC market and customer demand have led to this latest investment. As part of our POC offer we draw on our experience in ADCs to supply model antibodies to demonstrate suitability of client materials for use in ADC conjugation. We have worked on more than 65 ADC candidates and more than 30 different ADC drug linkers to date and also have experience with PEGylation, chelating conjugates for radioimmunotherapy and protein toxin conjugates.”
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