Dr. Andersen is a principal scientist in spray drying and enabling technologies at Janssen Research & Development, Belgium. He has an MBA in management & technology and a PhD in chemical engineering, with a specialization in nanoparticle technology. His main interests and experience include the development of drying processes for drug products, drug substances, intermediates, excipients for both R&D and industrial scale purposes, application of quality-by-design in drying processes, validation and qualification of spray dryers, advantages & disadvantages of spray vs freeze-drying processes, continuous man­ufacturing, and enabling technologies for drug products. His expertise has allowed him to give several presentations on international courses, while also publishing articles on the mentioned subjects. He has extensive experience in design and development of spray drying equipment and processes, bulk freeze-drying processes, GMP production, nanopar­ticles, powder processing in general, DoE and application of quality-by-design, validation and qualification of spray dryers, scale-up of spray drying processes, particle engineering, aseptic spray drying, project management, and early and late stage projects. Dr. Andersen has been with Janssen since April of 2017 and prior to his time at Janssen, he worked at Novo Nordisk for 10 years at GEA Niro A/S for 8 years.

Andrea Weiland, Ph.D., is managing director of Explicat® Pharma GmbH, a privatelyowned company providing technical project management services and pharmaceutical development services to the pharmaceutical industry (CMC). Andrea is a pharmacist with a PhD in pharmaceutical technology on biodegradable microspheres and cyclodextrins (Ludwig Maximilians University Munich). She held several leading roles within Pfizer, working as project manager in process technology and being responsible for technology transfer & process development, mainly on sustained release solid dosage forms. Within R&D she was a responsible scientist for pharmaceutical development (Phase I - III, candidate characterization, and lyophilisation projects). After joining IDEA AG, a biotechnology company based in Munich, Andrea Weiland held the position of director of pharmaceutical development and was responsible for process technology development, drug delivery system development (liposomes, patches), formulation of recombinant proteins, analytical development, and clinical supplies manufacturing. She also served as IDEA`s QP and is the founder of Explicat Pharma GmbH and has been the managing director since 2005. She and her team`s experience cover the development of biopharmaceuticals (e. g. recombinant factor VIII), development of lyoformulations and lyocycles, analytical development, related QA, and regulatory issues. Explicat Pharma has been assigned several projects involving the modern process validation approach, including lyocycle robustness testing. Andrea Weiland is a qualified individual and a member of AAPS and several other professional institutions based in Europe including APV, DphG, Bay. LAK, and A3P.

Erik Skibsted studied chemical engineering at the Technical University of Denmark. After working with fluorescence sensor development, he started a PhD project at the University of Amsterdam in cooperation with Novo Nordisk in Denmark. In his PhD research, he worked with developing algorithms for near-infrared spectroscopic applications in the manufacturing of solid dosage forms and multivariate modelling of the entire manufacturing process variables. He joined Novo Nordisk after his PhD work, which included: protein characterisation, spectroscopic data analysis, troubleshooting manufacturing problems with multivariate modelling, process analytical technology, and implementation of quality by design (QbD).

After completing his master’s in polymer chemistry at the University of Louvain, Belgium, Bram Jongen acquired a PhD in water soluble polymers used for advanced drug adminis­tration. Bram started working as a technical support manager for Datwyler about 14 years ago, supporting customers in a vast area that spanned from Western European countries to countries like India, Korea, and South Africa. Thereafter, he headed the Global Product Introduction & Support team, a global team of highly experienced and educated people, each having their own expertise in the world of pharmaceutical closures. Bram himself ac­quired profound extractables & leachables expertise. His team managed customer projects of technical nature and supported Datwyler’s product and portfolio management. Since the end of 2012, he has been acting as head of R&D, leading a group that focuses on develop­ing new rubber and new coating materials.

Georg holds a degree in engineering from UAS, Cologne, Germany. He works as a facility & process engineer at the parenteral facility of Bayer Pharma in Leverkusen. Previously, he worked in a similar role for the Pilot Fill & Finish Facility of Janssen Pharma in Schaffhau­sen. Before 2012, he worked for Optima (Klee) and GEA Lyophil/Steris in the mechanical & process engineering of Lyophilisers for ten years. Among others, he is specialised in the development of customized freeze-drying processes (particularly upscaling with PAT) and in the qualification (FAT, SAT, IQ, OQ, PQ) of pharmaceutical freeze dryers.

Miguela is a senior research and development scientist at The Janssen Pharmaceutical Companies of Johnson & Johnson. She is an expert in pharmaceutical formulations and drug/vaccine delivery systems, where she is responsible for end-to-end drug product de­velopment for oral and parenteral delivery. Miguela is a Marie Curie PhD fellow and she received her PhD from the University of Florence, Frankfurt, and Utrecht for structural investigations on human proteins related to neurodegenerative disorders. Prior to joining Janssen, Miguela worked at Novartis Vaccines as a formulation scientist.

Ilona Vollrath graduated in pharmacy from Julius-Maximilians University in Würzburg and received her license as a pharmacist in 2013. For her PhD studies, she went to Munich and joined Prof. Dr. Winter at the Department of Pharmaceutical Technology and Biophar­maceutics (LMU Munich). In collaboration with Coriolis Pharma Research GmbH, she was working on controlled nucleation and novel PAT tools in freeze drying. In July 2017, Ilona joined Lonza`s Drug Product Services as a postdoctoral fellow in collaboration with Prof. Dr. Huwyler at the University of Basel. Her current projects focus on formulation develop­ment of advanced therapy medicinal products.

Richard Denk has studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, pharmaceutical engineering, and quality control at the University of Applied Sciences in Albstadt/Sigmaringen, Germany. Richard Denk works at SKAN AG, headquartered in Allschwil as the head of sales contain­ment. Mr. Denk founded the expert Containment group of the ISPE DACH 8 years ago. The Containment Group published the Containment Manual in September 2015. Mr. Denk has spent nearly 20 years with the subject production of highly active/highly hazardous substances and has developed the containment pyramid.

Claudia Kunz received her license as a pharmacist from Julius-Maximilians University in Würzburg in 2011. In 2013, she joined Priv.-Doz. Dr. Gieseler’s Freeze Drying Focus Group at the Friedrich-Alexander-University in Erlangen as a PhD student. Her research interests were focused on freeze drying from organic co-solvent systems as well as dynamic vapour sorption of freeze-dried products. Since August 2017, she is a principal scientist at Merck KGaA, where she is working on the characterization and early formulation development of NBEs and ADCs. Her current projects focus on the strategy for freeze-drying of highly potent agents and high concentration formulations.