The challenge of CMC regulatory compliance for biopharmaceuticals. ([2019])

• Record Type: Book
• Other Titles: Challenge of chemistry, manufacturing, and control regulatory compliance for biopharmaceuticals
• Further Information: Note: John Geigert.
• Other Names: Geigert, J (John), 1948-
• Contents: Complexity of Biologics CMC Regulation -- Biopharmaceutics are Not Chemical Drugs -- An Effective CMC Strategy is Possible -- Challenge of Adventitious Agent Control -- Biopharmaceutical Source Materials -- Manufacturing of Biopharmaceutical APIs -- Manufacturing of the Drug Product -- Complex Process-Related Impurity Profiles -- Product Characterization is a Journey -- Priceless Potency (Therapeutic Activity) -- Quality Attributes of a Biopharmaceutical -- Designing the Stability Program -- The Art of Setting Specifications -- Demonstrating Product Comparability After Process Changes -- Invaluable CMC-Focused Meetings with Regulatory Authorities.
• Edition: Third edition
• Publisher Details: Cham, Switzerland : Springer
• Publication Date: 2019
• Extent: 1 online resource
• Subjects: 615/.19; Pharmaceutical biotechnology industry -- Law and legislation; Pharmaceutical biotechnology -- Quality control; Biopharmaceutics -- standards; Guideline Adherence -- legislation & jurisprudence; Pharmaceutical biotechnology industry -- Law and legislation; Pharmaceutical biotechnology -- Quality control; United States; Electronic books; Electronic books
• Languages: English
• ISBNs: 9783030137540; 3030137546
• Related ISBNs: 9783030137533
• Notes: Note: Includes bibliographical references and index.; Note: Description based on online resource; title from digital title page (viewed on June 25, 2019).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.