Control strategy approach for a well-characterized vaccine drug product

P Kolhe, K Sunasara, L Lewis, MB Piatchek… - PDA Journal of …, 2020 - journal.pda.org
Trumenba (MenB-FHbp; bivalent rLP2086), the first meningococcal serogroup B vaccine
approved in the United States and subsequently approved in Europe, Canada, and …

FDA 2011 process validation guidance: lifecycle compliance model

C Campbell - PDA journal of pharmaceutical science and …, 2014 - journal.pda.org
This article has been written as a contribution to the industry's efforts in migrating from a
document-driven to a data-driven compliance mindset. A combination of target product …

Critical quality attributes, specifications, and control strategy

T Schofield, D Robbins, G Miró-Quesada - Quality by Design for …, 2015 - Springer
In a quality by design (QbD) program, once a process has been characterized and a design
space is established, process control of critical quality attributes (CQAs) needs to be …

[HTML][HTML] Control Strategy: A Feedback-Feedforward 'Controls Hub'for Risk, Knowledge, and Product Lifecycle Management

E Ramnarine - Pharmaceutical Technology, 2023 - pharmtech.com
A control strategy can function as a powerful “hub” to gain a comprehensive understanding
of the consolidated set of controls that are necessary to ensure consistent delivery of quality …

[PDF][PDF] Technical Regulatory Topic

B Manser - 2023 - pall.com
In recent years the development of Gene therapy drugs has seen a significant evolution.
Recombinant adeno associated viruses are regarded as one of the most promising gene …

Case studies in the development of drug substance control strategies

NM Thomson, R Singer, KD Seibert… - … Process Research & …, 2015 - ACS Publications
A series of case histories from IQ consortium member companies are presented in order to
exemplify many of the different elements of drug substance control strategies that are …

[PDF][PDF] Defining your product profile and maintaining control over it, part 1

H Simmerman, RP Donnelly - BioProcess Int, 2005 - eu-assets.contentstack.com
WWW. PHOTOS. COM and Controls (CMC) Strategy Forum was held 19–20 July 2004 at the
Lister Hill Auditorium on the National Institutes of Health Campus in Bethesda, MD …

[HTML][HTML] Strategies for setting patient-centric commercial specifications for biotherapeutic products

MN Ruesch, L Benetti, E Berkay, DJ Cirelli… - Journal of …, 2021 - Elsevier
Commercial specifications for a new biotherapeutic product are a critical component of the
product's overall control strategy that ensures safety and efficacy. This paper describes …

Retrospective implementation of quality by design for legacy commercialized enzyme replacement therapies

A Agarwal, E Hayduk - 2016 - dc.engconfintl.org
Abstract Quality by Design (QbD) has been widely adopted by the pharmaceutical industry
as a tool for transforming development, manufacture, and commercialization of drug …

[CITATION][C] Control Strategy as the Keystone of the Product Lifecycle, from Product/Process Understanding to Continuous Process Verification and Improvement

J Piriou, B Elissondo, M Hertschuh, R Ollivier - Pharmaceutical Engineering, 2012