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This phase is where manufacturing patent risk is highest: the reference product sponsors process patents, which may not be listed in the Purple Book but are discoverable through independent patent searching, can constrain the biosimilar developers process choices

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Because of this, sterile water is often used in: Single-use preparations Controlled experimental setups Situations where additives are not desired However, once a vial is accessed, sterile water provides no protection against microbial growth

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This is one reason cycling remains important