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P. 66-74 /

Analytical and formulation attributes in developing generic sterile injectable liquid and lyophilized drugs (part 2)


*Corresponding author
1. Boehringer Ingelheim, Ben Venue Laboratories, 300 Northfield Road, Bedford, OH 44146, USA
2. Current Address: Novartis Consumer Healthcare, Lincoln, NE, USA


Analytical development is a principal element with formulation development in the successful development and launch of a generic drug product. New generic filings must meet current industry standard and guidelines, however the branded drug company is often not required to update methods that were developed and filed under out-dated requirements and prior to the recent advancements in separation sciences and regulatory guidelines. Part 1 of this article discussed several aspects of the generic sterile injectable development processes including deformulation, API selection, container closure, filter validation and product compatibility studies. In the second part of this article, scale up considerations, lyophilization development is discussed along with the analytical development. Relevant USP/ICH guidelines with respect to the generic development are also highlighted.


Scale-up studies are important and should be afforded proper resources. Inadequate scale-up studies could lead to process validation failure due to lack of understanding of critical parameters that control the process. These failures can cause significant delays in launching and lead to lost revenues. Validation failures can often result in lengthy root cause investigations and sometimes may require reformulation. All of these can be avoided by designing proper scale-up studies that include but are not limited to the following:
a) Mixing studies: This study is done to evaluate critical mixing parameters and order of addition.
b) Bulk hold studies: This study is done to ensure product quality is not compromised over the length of routine manufacturing process.
c) Evaluation of equipment train: This is critical from the standpoint that the equipment train in the manufacturing plant has all the controls in place in order to manufacture a particular drug product. For example, if an inert atmosphere is required for a particular drug produ ...

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