HW 2 - !"#$%&'()%*+,%()-)%"./01.23%(% (1)...

Info iconThis preview shows pages 1–2. Sign up to view the full content.

View Full Document Right Arrow Icon
(1) Harrison prob 1.4 (cite the handbook and page no.). The Merck Index would be a good source. Ans: see Harrison key (Separate PDF File). (2) Harrison prob 1.8. Ans: see Harrison key (Separate PDF File). (3) For each item in Harrison table P2.1, give the product attribute that applies: purity, identity, biological activity, potency, or physical/appearance. Also try to indicate for each purity attribute, add whether the attribute pertains to either (A) a product-related impurity, (B) a non-product-related impurity, or (C) a contaminant. Product-related impurities detect unwanted variants in the product molecule itself. Non- product impurities detect impurities brought in with the biological process used to make the product that themselves are not derivatives of the product molecule. They are intrinsic to the process used. Contaminants are substances that get into the process from the plant environment. Ans: Table P2.1: Item attribute remark Purity by rev phase Purity - A Purity by SEC purity - A Purity by IEC Purity - A Identity by tryptic map identity Leached Ab Purity - B Could accept purity-C as an answer here ECP Purity-B DNA Purity-B bioassay biological activity Product content potency “content” refers to concentration of product Endotoxin Purity-B or C bioburden Purity-C pH Physical/appearance appearance Physical/appearance One of the challenges for bioseparations processes is the difficulty determining and reproducibly meeting the purity limits in the product specification. In effect, purity is defined by a broad set of attributes or measures, some quite sophisticated and difficult to analyze. To simply say a biomolecule is “pure” is an empty statement You need to declare “purity with respect to a given class of impurity”, some of which are non-product impurities coming from the biological source, some are product-related variants given the complexity of the molecule and its susceptibility to being made incorrectly or being degraded, and some are contaminants that are not intrinsic to the process but can slip in (like bioburden). Also, it is very difficult to correlate purity to the function of the product, (its safety, efficacy, stability in case of a drug). This difficulty adds to risk and expense of product development a great deal.
Background image of page 1

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
Image of page 2
This is the end of the preview. Sign up to access the rest of the document.

Page1 / 4

HW 2 - !"#$%&'()%*+,%()-)%"./01.23%(% (1)...

This preview shows document pages 1 - 2. Sign up to view the full document.

View Full Document Right Arrow Icon
Ask a homework question - tutors are online