Andrea Weiland, Ph.D., is managing director of Explicat® Pharma GmbH, a privately owned company providing technical project management services and pharmaceutical development services to Pharmaceutical Industry (CMC).

Andrea is a pharmacist with a Ph.D. in pharmaceutical technology on biode­gradable microspheres and cyclodextrins (Ludwig Maximilians University Mu­nich). She held several leadership positions 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 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 pharmaceutical development and was responsible for process technology development, drug delivery system development (li­posomes, patches), formulation of recombinant proteins, analytical develop­ment, and clinical supplies manufacture; she also served as IDEA`s QP. She is founder of Explicat Pharma GmbH and managing director since 2005. Hers and her team`s experience cover the development of biopharmaceuticals (e. g. recombinant factor VIII), development of lyoformulations and lyocycles, analytical development and related QA as well as regulatory issues. Expli­cat Pharma has been assigned several projects involving the modern process validation approach, including lyocycle robustness testings. Andrea Weiland is qualified person and a member of AAPS as well as several other professional institutions based in Europe, e.g. APV, DphG, Bay. LAK, A3P.

Geoff Smith is a Professor of Pharmaceutical Process Analytical Technology in the Leicester School of Pharmacy at De Montfort University (UK). His research group focusses on pharmaceutical applications for impedance, dielectric and terahertz spectroscopies alongside optical techniques such as laser speckle and optical flow. He is responsible for the development of through vial impedance spectroscopy (TVIS) as a PAT tool for monitoring phase behaviour (ice formation and eutectics), ice interface temperatures, primary drying rates and end points. More recently, and in collaboration with Biopharma, he developed Z-FDM - a freeze-drying microscope with an integrated impedance spectrometer, for the objective assessment of the collapse temperature and for the determination of ice nucleation temperatures, solidification times, and drying rates. Prof. Smith’s presentation will focus on both the TVIS and Z-FDM technologies with the view to demonstrating how a one physical measurement (impedance spectroscopy) might be used across all scales of the product and process development cycle.

Dr. Mostafa Nakach is a PhD from Toulouse University. He has prepared his thesis on stabilisation and production of nanocrystalline suspension. He is also а Master II graduate from Paris-Sud University in pharmacotechnie and biopharmacy, and a pharmaceutical engineer from École des mines d’Albi. Mostafa has been working within Sanofi Group for 32 years. His current position is a head of formulation and process development section within biologics drug product development. His mission is to build and to manage the required skills and capabilities in order to support R&D projects development mainly for fill and finish commercial process development of biotech products, including freeze-drying.

Dr. Stefan Schneid is currently a laboratory head in the formulation development department at Bayer AG. In this function, he develops formulations and processes for novel biological entities and small molecules, and is involved in development projects from pre- clinical stage up to transfer to commercial production. Previously, Stefan worked as R&D manager at Syntacoll GmbH in Saal, Germany, where he was responsible for the development of novel formulations and analytical methods for drug-containing biodegradable implants for parenteral application. Until 2010, he was a post-doctoral research fellow in the freeze-drying focus group at the University of Erlangen, and spent one year as a visiting scientist in Prof. Michael Pikal’s lab at the University of Connecticut. Stefan holds a degree of pharmacy from the University of Munich, and received his PhD in pharmaceutics from the University of Erlangen in 2009 for his dissertation thesis titled “Investigation of Novel Process Analytical Technology (PAT) Tools for Use in Freeze-Drying Processes”. He developed and optimised the formulation and manufacturing process of various predominantly lyophilised pharmaceuticals including proteins, peptides, vaccines and small molecules.

Dr. Paul Matejtschuk leads a formulation and freeze-drying team at NIBSC focussed on delivering lyo solutions for biological reference materials, many of them WHO international reference preparations (joined NIBSC in 2001). He has over 30 years’ postdoctoral experience in downstream processing and analysis of biologics, and has co-authored over 40 peer-reviewed papers and co-supervised several PhD students with Prof. Paul Dalby (UCL, London). Paul is one of a number of directors of the International Society for Lyophilisation Freeze Drying, a not-for-profit society whose aim is to enhance global understanding and uptake of best lyophilisation practices. Co-edited (2019) with Dr. Kevin Ward (Biopharma Technology Ltd, UK) a recent volume on “Lyophilization of Pharmaceuticals & Biopharmaceuticals“ for Springer in the “Methods in Pharmacology & Toxicology” series.

Franz Bosshammer has a degree in mechanical engineering, as well as an MBA. Prior to joining NNE Pharmaplan in October 2012, Franz has filled various positions, such as process engineer and sales director in the supplying industry for pharmaceutical, aseptic fill and finish machines. His latest employment was as a general manager at Optima Group Pharma. He started his career in the field of process engineering in 1986. Franz has more than 30 years of experience in development and manufacturing of machines for aseptic pharmaceutical operations, with a special focus on freeze-drying technology. Franz has been engaged in various international fill and finish projects over the course of his career.

Xulei Wu serves as KBR Deputy Contractor Manager in the Space Food Systems Laboratory at NASA Johnson Space Center. In this role, she supports the space food production and delivery to International Space Station to support Human Space Exploration with safe, nutritious, palatable, and sufficient food. Prior to this role, she worked for over two years in the same lab as a Sr. Food Scientist, led the freeze-drying production, reformulated products to improve safety/efficiency/sensory profile, and conducted R&D work to optimize the freeze-drying cycle. Xulei recruited and trained an R&D sensory panel to support freeze-drying cycle optimization and shelf-life study. Prior to supporting NASA, she was with Oregon Freeze Dry in various QA and R&D roles. Her specialty is in freeze-drying technology, low moisture food, sensory evaluation, and shelf-life study. She earned a B.S. in food science and engineering from Shanghai Jiao Tong University and an M.S. in food science and technology from Oregon State University.

Richard Denk 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 works at SKAN AG, headquartered in Allschwil, as the head of sales containment, and eight years ago he founded the expert containment group of the ISPE DACH. The containment group published the Containment Manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.

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.

Giel De Winter obtained a Master’s degree in Bioscience Engineering, with an emphasis on surface chemistry, (bio-)catalysis, and biotechnology. Giel has over 6 years of experience in several focus areas of the pharmaceutical industry. He currently works at the Pfizer Aseptic Manufacturing site in Puurs, Belgium, as a Process Development Scientist in the Manufacturing Science and Technology (MSAT) department. There he is responsible for Tech Transfers, troubleshooting, and process optimizations. His work primarily focuses on lyocycle development and optimization for both small and large molecule formulations, aseptic process development, and product and process characterization initiatives.

Dr.-Ing. Nga Le is the Process Engineer at Fluid Air, a division of Spraying Systems Co®. She got a doctorate in mechanical engineering and a Master’s degree in chemical engineering. She was a lecturer at Hanoi University of Science and Technology, Vietnam, from 2009 to 2012; and a researcher at the Technical University of Dresden, Germany, from 2012 to 2018. Joining Fluid Air in 2019, she will be responsible for the production lab in North Rhine-Westphalia, Germany. Her expertise is spray drying, advanced oxidation processes, and the isolation of active compounds from natural products.

Dr. Christoph Strubl is the owner and General Manager of STRUBL GmbH & Co. KG Packaging, Germany, a family company supplying cleanroom packaging materials for the pharmaceutical / medical devices / healthcare industry.

He has more than 20 years of experience in the plastic packaging market. Since 2015 he is a speaker of the board of the Workgroup "Pharmaceutical Packaging" and a Member of the Steering Committee of IK Industrievereinigung Kunststoffverpackungen e.V., the German Association for Plastics Packaging and Films.

He holds a Ph.D. in business and management sciences from the University of Erlangen, Germany.