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Silver Spring, MD, United States

Lolas A.G.,Office of Compliance | Metcalfe J.W.,Office of Pharmaceutical science
PDA Journal of Pharmaceutical Science and Technology | Year: 2011

The microbial growth potential of a pharmaceutical drug product refers to the ability of microorganisms to survive and proliferate in the product. Each drug formulation possesses a different potential for supporting or inhibiting microbial growth. Understanding this microbial growth potential can have a significant effect on the development and design of the drug manufacturing process. This article describes how this attribute can exert this effect on manufacturing process development and design through real examples and case studies obtained from the regulatory review of new drug and biologics license applications. In addition, this article describes how understanding the microbial growth potential of a pharmaceutical drug product is an element of the Quality by Design paradigm and how this understanding can simplify the drug development process and lead to better process design. ©PDA, Inc. 2011.


Riley B.S.,Office of Pharmaceutical science | Li X.,Office of Pharmaceutical science
AAPS PharmSciTech | Year: 2011

Quality by design (QbD) and process analytical technology (PAT) have become priorities for the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). Numerous recent initiatives within CDER and FDA have had the objective of encouraging the pharmaceutical industry to utilize QbD and PAT in their product development and manufacturing processes. Although sterile products may be a minority compared to non-sterile dosage forms (e.g., solid orals), their absolute requirement for sterility make design and control of the manufacturing processes extremely critical. This emphasis on the manufacturing process makes the sterile drug product an obvious target for QbD and PAT. Although the FDA encourages QbD submissions, the utilization of QbD and PAT for sterile products so far is still limited. This paper will examine the present state of QbD and PAT for sterile products and review some examples currently in use. Additional potential applications of QbD and PAT for sterile product development and manufacturing will also be discussed. © 2010 American Association of Pharmaceutical Scientists.


Read E.K.,Office of Pharmaceutical science | Shah R.B.,Office of Pharmaceutical science | Riley B.S.,Office of Pharmaceutical science | Park J.T.,Office of Pharmaceutical science | And 2 more authors.
Biotechnology and Bioengineering | Year: 2010

Implementing real-time product quality control meets one or both of the key goals outlined in FDA's PAT guidance: ''variability is managed by the process'' and ''product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions.'' The first part of the paper presented an overview of PAT concepts and applications in the areas of upstream and downstream processing. In this second part, we present principles and case studies to illustrate implementation of PAT for drug product manufacturing, rapid microbiology, and chemometrics. We further present our thoughts on how PAT will be applied to biotech processes going forward. The role of PAT as an enabling component of the Quality by Design framework is highlighted. Integration of PAT with the principles stated in the ICH Q8, Q9, and Q10 guidance documents is also discussed.


Read E.K.,Office of Pharmaceutical science | Park J.T.,Office of Pharmaceutical science | Shah R.B.,Office of Pharmaceutical science | Riley B.S.,Office of Pharmaceutical science | And 2 more authors.
Biotechnology and Bioengineering | Year: 2010

Process analytical technology (PAT) has been gaining momentum in the biotech community due to the potential for continuous real-time quality assurance resulting in improved operational control and compliance. In this two part series, we address PAT as it applies to processes that produce biotech therapeutic products. In the first part, we address evolution of the underlying concepts and applications in biopharmaceutical manufacturing. We also present a literature review of applications in the areas of upstream and downstream processing to illustrate how implementation of PAT can help realize advanced approaches to ensuring product quality in real time. In the second part, we will explore similar applications in the areas of drug product manufacturing, rapid microbiology, and chemometrics as well as evolution of PAT in biotech processing.

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