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Andrea Weiland-Waibel

Andrea Weiland-Waibel
Explicat Pharma · CMC

PhD

About

15
Publications
4,184
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Additional affiliations
January 2005 - September 2015
Independent Researcher
Independent Researcher
Position
  • Managing Director
Education
November 1985 - January 1995
Ludwig-Maximilians-University of Munich
Field of study
  • Pharmacy, Dr. rer nat pharmaceutical technology

Publications

Publications (15)
Conference Paper
Full-text available
Critical Quality Attributes are linked to the critical formulation temperature and critical product parameters. Process robustness testing during development is explained and the implementation into the regulatory documents as well as an overview on cpv of the product analysing the lyocycle as well as the critical quality attribute residual moistur...
Article
Full-text available
Wireless temperature measurement during lyo process development, validation and production with the aim to apply process control. This is performed by the determination of product temperature Tp in critical positions ("hot" and "cold" spots). Also it is explained how this approach was implemented into the Common Technical Document (CTD) regulatory...
Poster
Full-text available
The Poster deals with the optimization of freeze drying conditions for Sulfobutyl-ether-ß-cyclodextrin and explains the benefit of annealing to reduce cosmetic defects.
Presentation
Full-text available
Process control using Product Temperature and results applying continued process verification of a lyocycle
Presentation
Full-text available
Presentation covering the analysis of critical quality attributes and their interrelationship with critical process and product parameters regarding lyophilization, the performance of lyorobustness studies and the concept of a general lyocycle based on requirements of vacuum and product temperature
Article
Full-text available
Modern lyophilization development utilizes ICHQ8, ICHQ9 and ICHQ10 and PAT in Lyophilization the product temperature determination is of utmost importance
Presentation
Full-text available
Critical quality attributes and critical process parameters: robustness testing to establish process boundaries; process qualification/validation in lyophilization strategies in relation to FDA/EMA Modern Process Validation Guideline
Conference Paper
Full-text available
PAT-Tools as real-time process control, dynamic qualification of "Hot and Cold Spots", case study
Article
Full-text available
Traditional lyo cycle development leads to a predetermined program that usually is subject of process validation. As a consequence this cycle needs to be applied for the fabrication of the product under all circumstances. If for any reasons e. g. only a part of a total batch size can be manufactured, no adaptations are possible, i. e. the shortenin...
Conference Paper
Full-text available
Performance Qualification (PQ) plays an important role in modern approaches towards process validation from as early as lab scale development up to routine manufacture, particularly in aseptic lyophilisation technology. PAT tools are crucial in monitoring, optimizing and validating such freeze drying processes, especially if the same tool can be us...
Chapter
Full-text available
Summary Use of Risk Assessment Tables during Development Stage The paper addresses the importance of analysis of the critical pharmaceutical process parameters during development stage. Practical recommendations are given as to how to apply this approach to manage the pharmaceutical development process and utilize the data package. The approach is...
Patent
Full-text available
Process for spatial separation of at least two active ingredients or auxiliaries A and B in solid medicament forms
Patent
Full-text available
Das Verfahren beschreibt die räumliche Trennung von mindestens zwei Wirkstoffen A und B in festen Arzneimittelformen, wobei ein Schmelzverfahren gemäß EP 0043254 angewandt wird, mit der Massgabe, dass man den Wirkstoff A gleichmässig in die höherschmelzende lipide oder lipoide Komponente einarbeitet und das so erhaltene Gemisch granuliert oder auf...
Thesis
Full-text available
manufacturing and characterization of biodegradable microspheres using poly(D,L-lactide-co-glycolide) and cyclodextrin-complexes with bupivacain hydrochloride to yield parenteral sustained release systems

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