Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 27 ASTM provides an open and balanced process for standards development. With stakeholders around the world, E-55 members can participate and maintain an equal voice in the development and approval of standards, explains Travis Mur- dock, manager of ASTM's technical committee operations. "Participation within E-55 is open to any and all stakeholders with interests related to the standards being developed," he says. LyoHub was attracted to the transparency and inclusivity of standards setting via ASTM, says Ferdinando Aspesi, chair of the organization's E-55 committee for pharmaceutical and biophar- maceutical manufacturing. "It's a place where one can write standards for any industry, to ensure that the best science and technology available are used to protect patients and to standardize the ways we develop and make products and establish how to's for consistent results backed by sound rationale. Lyophilization was a natural fit for standardiza- tion, he explains, since it has been widely used for decades. Although the industry has automated more equipment and processes, the basic approach to lyophilization has not been modernized, and the practices are sometimes based on legacy rather than sound rationale. Moreover, the process is in- efficient and costly, he says. One of the biggest problems is the conservative design of the process due to lack of knowledge of the process and equipment limits. Even though more pharmaceutical manufacturers are moving to smaller batches of product, lyophilization is still mainly done on a grand scale, with 50,000 to 100,000 vials typical per batch. This leads to vari- ability with scale, Aspesi says. Because all vials are not exposed to the same drying conditions, the result could lead to variable product characteristics. "This is really a physics problem, and results in pro- cess inefficiency as well as quality issues," he notes. The industry has realized that it doesn't need to process so much material at one time, says As- pesi. "Equipment manufacturers are responding by changing designs. Where lyophilizer shelves used to target 50 m 2 in the past, some vendors are now looking at 1 m 2 ." There is also a need to optimize lyophilization for use in biopharmaceutical manu- facturing, particularly for monoclonal antibodies, bioproteins, and cell therapies, he says. LyoHu b d rove t he for m at ion of E -55. 05, which currently involves over 100 representa- tives from bio/pharma manufacturers, equip- ment designers and suppliers, researchers, and ac adem ic s. Represent at ive s f rom FDA a nd NIST are also participating in the group. Arnab Ga ng u ly, cha ir of E-55.05's new subcommit- tee on lyophilization and scientist/technolog y manager at IMA Life and formerly at Purdue University's School of Aeronautics and Astro- naut ics, shared insights into E-55.05's goa ls with Pharmaceutical Technology. The road to standard setting PharmTech: Why did LyoHub establish the standard committee? "There is a need for lower cost, better product quality, improved compliance, and consistent quality for each vial of product within the same batch." —Ferdinando Aspesi, ASTM

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