scholarly journals Gene Therapy: Development, Design of Studies, and Approval Process

2021 ◽  
Vol 3 (3) ◽  
pp. 1-4
Author(s):  
Kaiser Jay Aziz ◽  
Keyword(s):  
Gene Therapy ◽  
Life Cycle ◽  
Manufacturing Process ◽  
Product Life Cycle ◽  
Management Approach ◽  
Post Marketing Surveillance ◽  
Total Product ◽  
Post Marketing ◽  
Critical Process Parameters ◽  
Process Controls

Genome editing can be applied to various areas of medical diagnosis and treatments. Gene therapy pre-market applications comprise of systematically assessing a product’s design controls, manufacturing process controls, and proposed protocols for post-marketing surveillance. Quality risk management principles have been described in various FDA regulatory guidances for several aspects of good manufacturing practices (GMPs) such as several stages of process validation and verification in the genome product’s life cycle including critical quality attributes (CQAs) and monitoring critical process parameters (CPPs). A CPP is defined as a process parameter whose variability has an impact on a CQA of genome product and, therefore, should be monitored or controlled to ensure that the manufacturing process produces an end product of the desired quality. FDA’s mission is to facilitate the premarket review and evaluation of new genomic products for clinical use. The FDA guidances emphasize a quality management approach to the design of studies by providing oversight and objective review based on risk-benefit analysis of new genomic products. FDA reviews, evaluates, verifies and validates the implementation of the regulatory design-control requirements which are applied to the control genomic product’s quality throughout the total product life cycle (TPLC) [1-5].

scholarly journals Genome Editing: New, Emerging, and Interesting Developments for Clinical Applications

2021 ◽  
Vol 3 (1) ◽  
pp. 1-4
Author(s):  
Kaiser Jay Aziz ◽  
Keyword(s):  
Genome Editing ◽  
Drug Product ◽  
Clinical Applications ◽  
Management Approach ◽  
Clinical Use ◽  
Design Development ◽  
Post Marketing Surveillance ◽  
Good Manufacturing Practices ◽  
Post Marketing ◽  
Critical Process Parameters

Principles of Genome Editing can be applied in the various areas of medical diagnosis and treatments ---from early process design/development through maintenance of the validated state during commercial manufacturing and post-marketing surveillance. Gene editing and clinical applications comprises of systematically assessing, monitoring, and reviewing manufacturing processes and subsequently monitoring measures to control output risks. Quality risk management (QRM) principles have been described in various FDA’s regulatory guidances for several aspects of good manufacturing practices (GMPs) such as several stages of process validation and verification in the drug product lifecycle including critical quality attributes (CQA’s) and monitoring critical process parameters (CPPs). A CPP is defined as a process parameter whose variability has an impact on a CQA and, therefore, should be monitored or controlled to ensure that manufacturing process produces end product of the desired quality. FDA’s mission is to facilitate the premarket review and evaluation of new genomic products for clinical use. The FDA guidances emphasize quality management approach to design of studies by providing oversight and objective review based on risk-benefit analysis and guides the use of new medical products by providing patients organized data and appropriate labeling information in support of the new product’s intended clinical use [1-3].

Study on Geometric Tolerances Information in Integrated Manufacturing Processes

2010 ◽  
Vol 37-38 ◽  
pp. 1292-1295
Author(s):  
Yan Chao ◽  
Hai Feng Zhang ◽  
Li Qun Wu
Keyword(s):  
Life Cycle ◽  
Data Model ◽  
Manufacturing Process ◽  
Product Life Cycle ◽  
Critical Role ◽  
Manufacturing Processes ◽  
Product Life ◽  
Internet Technologies ◽  
Geometric Tolerance ◽  
Geometric Tolerances

Tolerance information plays a critical role in many steps of the product life cycle. It is especially important due to the advances in Internet technologies and increasing integration requirements from industry. In this paper, geometric tolerances information in manufacturing process (IMP) is studied, and the layered conformance level of geometric tolerances is established according to ASME Y14.5-1994, STEP and DMIS. An EXPRESS-G data model of geometric tolerance information in IMP is established. The XML language is used to represent and program the geometric tolerances information in IMP.

scholarly journals Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software

2021 ◽  
Vol 8 ◽  
Author(s):  
Staci J. Kearney ◽  
Amanda Lowe ◽  
Jochen K. Lennerz ◽  
Anil Parwani ◽  
Marilyn M. Bui ◽  
...  
Keyword(s):  
Life Cycle ◽  
Product Development ◽  
Product Life Cycle ◽  
Critical Role ◽  
Clinical Aspects ◽  
Product Life ◽  
Early Evaluation ◽  
Regulatory Affairs ◽  
Product Regulation ◽  
Total Product

Manufacturers of pathology imaging devices and associated software engage regulatory affairs and clinical affairs (RACA) throughout the Total Product Life Cycle (TPLC) of regulated products. A number of manufacturers, pathologists, and end users are not familiar with how RACA involvement benefits each stage of the TPLC. RACA professionals are important contributors to product development and deployment strategies because these professionals maintain an understanding of the scientific, technical, and clinical aspects of biomedical product regulation, as well as the relevant knowledge of regulatory requirements, policies, and market trends for both local and global regulations and standards. Defining a regulatory and clinical strategy at the beginning of product design enables early evaluation of risks and provides assurance that the collected evidence supports the product's clinical claims (e.g., in a marketing application), its safe and effective use, and potential reimbursement strategies. It is recommended to involve RACA early and throughout the TPLC to assist with navigating changes in the regulatory environment and dynamic diagnostic market. Here we outline how various stakeholders can utilize RACA to navigate the nuanced landscape behind the development and use of clinical diagnostic products. Collectively, this work emphasizes the critical importance of RACA as an integral part of product development and, thereby, sustained innovation.

Regulatory Aspects of Total Product Life Cycle

2004 ◽  
Vol 6 (6) ◽  
pp. 761-766 ◽  
Author(s):  
Ethan D. Hausman ◽  
Sousan S. Altaie
Keyword(s):  
Life Cycle ◽  
Product Life Cycle ◽  
Product Life ◽  
Regulatory Aspects ◽  
Total Product

scholarly journals Product life cycle management approach for integration of engineering design and life cycle engineering

2016 ◽  
Vol 30 (4) ◽  
pp. 379-389 ◽  
Author(s):  
Diana Penciuc ◽  
Julien Le Duigou ◽  
Joanna Daaboul ◽  
Flore Vallet ◽  
Benoît Eynard
Keyword(s):  
Life Cycle ◽  
Product Life Cycle ◽  
Sustainability Assessment ◽  
Material Selection ◽  
Life Cycle Management ◽  
Management Approach ◽  
Product Life ◽  
Product Life Cycle Management ◽  
Cycle Simulation ◽  
Material Choice

AbstractOptimized lightweight manufacturing of parts is crucial for automotive and aeronautical industries in order to stay competitive and to reduce costs and fuel consumption. Hence, aluminum becomes an unquestionable material choice regarding these challenges. Nevertheless, using only virgin aluminum is not satisfactory because its extraction requires high use of energy and effort, and its manufacturing has high environmental impact. For these reasons, the use of recycled aluminum alloys is recommended considering their properties meet the expected technical and environmental added values. This requires complete reengineering of the classical life cycle of aluminum-based products and the collaboration practices in the global supply chain. The results from several interdependent disciplines all need to be taken into account for a global product/process optimization. Toward achieving this, a method for sustainability assessment integration into product life cycle management and a platform for life cycle simulation integrating environmental concerns are proposed in this paper. The platform may be used as a decision support system in the early product design phase by simulating the life cycle of a product (from material selection to production and recycling phases) and calculating its impact on the environment.

scholarly journals The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices

2017 ◽  
Vol 11 (2) ◽  
Author(s):  
Tina M. Morrison ◽  
Maureen L. Dreher ◽  
Srinidhi Nagaraja ◽  
Leonardo M. Angelone ◽  
Wolfgang Kainz
Keyword(s):  
Life Cycle ◽  
Computational Modeling ◽  
Modeling And Simulation ◽  
Medical Devices ◽  
Product Life Cycle ◽  
Product Life ◽  
Regulatory Decision ◽  
Total Product ◽  
Regulatory Submissions ◽  
Computational Modeling And Simulation

The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postmarket changes or failures. For example, computational solid mechanics and fluid dynamics enable the investigation of design limitations in the ideation stage. To supplement bench data in regulatory submissions, manufactures can evaluate the effects of anatomical characteristics and expected in vivo loading environment on device performance. Manufacturers might also harness CM&S to aid root-cause analyses that are necessary when failures occur postmarket, when the device is exposed to broad clinical use. Once identified, CM&S tools can then be used for redesign to address the failure mode and re-establish the performance profile with the appropriate models. The Center for Devices and Radiological Health (CDRH) wants to advance the use of CM&S for medical devices and supports the development of virtual physiological patients, clinical trial simulations, and personalized medicine. Thus, the purpose of this paper is to describe specific examples of how CM&S is currently used to support regulatory submissions at different phases of the TPLC and to present some of the stakeholder-led initiatives for advancing CM&S for regulatory decision-making.

Sign in / Sign up

Export Citation Format

Share Document