Andrew Bright is a Senior Consultant within the Product Lifecycle Management team a subject matter expert and plays a pivotal role in drug development projects, working as a project manager to create and implement key strategic plans for a variety of life-science clients and manages complex manufacturing and transfer projects for products under development or currently licensed.

Andrew previous experience includes time as a Technology Specialist within the Pharma Applications Group at Croda focusing on delivering applications data for marketed excipients and novel excipients, during this time Andrew set up a dedicated protein analytical lab to generate applications data.

And has held positions as Principal Scientist in Formulation & Lyophilization at Centre for Process Innovation (CPI) and Team Leader in Analytical Formulation Development at CPI specializing in the formulation, fill-finish, analytical development, and manufacturing development of liquid and freeze-dried biologics products.

He also held a Senior Scientist position at the Biopharma Group in which he developed freeze-dried formulations and conducted freeze-drying cycle development, training, and consultancy. And spent two years as a Senior Scientist for Pfizer within liquid formulations specializing in freeze-dried formulation design, process development, and scale-up.

Andrew has developed formulations and manufacturing process for a wide variety of products ranging from vaccines, proteins, LNPs, Exosomes, Mammalian and Bacterial cells, small molecules, and other novel therapeutics.

Andrew received his Ph.D. from the University of Bradford. There, he was investigating vaccine formulations with the thesis title "Mechanistic Insights into the Stabilization of Biopharmaceutical Using Glycine Derivatives" and holds a MChem in Chemistry with Pharmaceutical and Forensic Science.

Varadharaj Vijayakumar is an Associate Director (Aseptic Processing) at Wuxi Biologics, bringing over 16 years of experience in the Pharma/BioPharma industry. Specializing in pharmaceutical technical operations, his expertise encompasses aseptic processing, sterility assurance, manufacturing technology, process validation, failure investigations, troubleshooting, continuous improvement, and Lyophilization Technology. He is also highly skilled in Isolators with VHP cycle developments and resolving complex technical, regulatory, and GMP issues.

 Throughout his career, Varadharaj has successfully managed GMP inspections and audits, addressing inspectional observations from leading regulatory bodies such as WHO, USFDA, UK-MHRA, ANVISA, INVIMA, and CDSCO. His broad experience includes working with well-established pharmaceutical and biologics manufacturers, including WUXI Biologics Germany, Franz Ziel GmbH Germany, Pfizer India, Dr. Reddy's Laboratories Ltd, Emcure Pharmaceuticals (Oncology Division), and Biocon Biologics (India) Ltd.

Varadharaj has played an integral role in numerous projects, from concept design (greenfield and brownfield) to the successful commercialization of products and their continuous improvement. He has led teams in tackling operational and regulatory challenges, including regulatory reviews, production output, validation constraints, and addressing inspectional observations.

A registered pharmacist with a postgraduate degree in Pharmaceutical Sciences, Varadharaj is an active member of professional organizations such as ISPE, PDA, GENAP Summit, Pharma Days, Innovotrix, TBM, Speak Pharma, R&Y, Conferenzia, and Lyophilization World.

In addition to his industry work, Varadharaj contributes to the field by publishing technical articles, teaching students, and delivering webinars and training sessions on topics like qualification and validation for aseptic processing. His international experience, which spans countries such as Russia, the UK, the USA, Ireland, India, and Germany, has allowed him to train operational personnel through both short-term assignments and long-term global engagements.

Mostafa Nakach is PhD from Toulouse University.  He has prepared his thesis on stabilization and production of nanocrystalline suspension. He is also Master 2 graduate from Paris-sud 11 university in Pharmacotechnie and Biopharmacy and Pharmaceutical engineer from Ecole des Mines d’Albi. Mostafa is working within Sanofi group for 37 years. 

Currently, Mostafa is working within biologic drug product development as global head of process engineering. His mission is to serve as single point of contact for the characterization, development and scale-up of commercial manufacturing process for parenteral drug products across all biological modalities within global CMC portfolio.

Andrea Weiland, PhD, is managing director of Explicat® Pharma GmbH, a 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. She held several leadership positions within Pfizer, working as project manager in process technology and within R&D, where she was a responsible scientist for pharmaceutical development (Phase I - III, candidate characterisation and lyophilisation projects).

Rolf Lenhardt is the Managing Director of Teclen GmbH, based near Munich, Germany. He holds a degree in Process Engineering from the Technical University of Munich and brings nearly 20 years of experience in the pharmaceutical supply industry. As an engineer in the original sense of the word—derived from the Latin ingenium, meaning invention—he is a true inventor, known for developing practical solutions to complex challenges in sterile manufacturing.

At this conference, Rolf will present on the topic “Lyophilization process with a single-use disposable approach”, sharing insights into how disposable technologies can enhance contamination control and process reliability in freeze-drying applications. His deep understanding of GMP requirements and process optimization makes him a valued contributor to the field.