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Regulatory burdens weigh on combination product manufacturers

Regulatory matters, processing and manufacturing, as well as fill/finish and packaging rank as the most challenging areas for makers of combination products.
Regulatory issues represented the primary challenge for combination product makers, closely followed by processing and manufacturing, and then fill/finish and packaging. These details provide keen insight into manufacturer needs, particularly for consultants and suppliers involved in these topical areas.As far as what broader categories of combination products were manufactured by their companies, the slim majority of respondents listed pharmaceuticals/biologics, but clearly industry is incorporating all three broader categories, including medical devices, into their combination product mix.The largest number or survey respondents said their companies have produced combination products for more than 20 years. Conversely, the smallest number indicated their companies have only been making these products for less than two years, indicating that respondents to this survey have considerable experience in producing combination products.Not surprisingly, the 15° to 30°C and 2° to 8°C temperature ranges were the most frequently mentioned responses to a question about what temperature range must be maintained for their combination products. These so called 'controlled temperature' and 'cool or cold chain' designations are common subject areas addressed at healthcare-centric conferences, trade shows, and exhibitions.Combination products continue to develop and evolve. Based on a list developed from the U.S. FDA’s website, respondents cited tissue and tissue products, and cellular and gene therapy products as the offerings that best represented the combination products made by their companies.The U.S. Food and Drug Administration is sometimes thought of as having dual roles of enforcement and approval. The agency’s Office of Combination Products was far and away the preferred choice of respondents asked to select what organization or social media group was best to help them navigate combination product-related issues.Combination product survey respondent titles.Combination product company information.

Exciting medical treatment advances in the years ahead may well stem from the creative deployment of combination products (combinations of biologics, medical devices, and/or pharmaceuticals). Associating combination products with the future is understandable, yet it might surprise some to learn that many companies producing these ever-developing products have been at it for more than 20 years.

That was one of the findings of an exclusive survey conducted in late 2013 by Healthcare Packaging. Exactly 100 manufacturer/end-user professionals answered the e-mail survey. Package development/engineering/R&D represented the largest respondent group. Because most of the questions permitted more than a single answer, the actual response count to those questions surpassed 100, as evidenced in the accompanying charts.

When we asked what precise bit of information would best help your company succeed in its combination product packaging efforts, regulatory issues were mentioned often. Respondents sought guidance on matters ranging from “regulatory requirements for combination products that have multiple suppliers” to a “monthly overview of country-specific regulations and possible pathways to comply with those regulations.” Other requests included information on “validation, FDA regulations, and track and trace,” and “clearer regulatory pathway knowledge.”

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Combination product survey respondents also sought technical details such as “definition of stability requirements,” “streamlined processes, packaging activities, and thermal protection,” and “information related [to] sterilization for these types of packaging, new concepts, and shelf life.”

More details on temperature-controlled distribution and logistics were also expressed as subjects with which respondents wanted more clarity. For example, one respondent remarked, “Clear guidelines on packaging, shelf life/aging, and temperature control requirements.” Another noted, “Data or a defined procedure on how to forecast the chemical or physical stability under various conditions (temperature and humidity) of final product in relation to packaging configuration.”

The FDA’s Office of Combination Products is a good resource to learn about combination products, to understand guidance and regulatory details, and to find out about upcoming OCB meetings, conferences, and workshops.


Read more articles on combination products.

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