Justin O. Neway, Ph.D., Executive Vice President and Chief Science Officer for Aegis Analytical Corporation, has over 30 years of experience in biotechnology and pharmaceutical process developmen... [ view bio ]

Operational Excellence has the potential to bring huge benefits and prepare the biopharmaceutical industry for its current and upcoming challenges, provided it is implemented in a radical way. In... [ view bio ]

Dr. Ralf Gleixner is Senior Director Biotech Process Sciences Quality Systems, Merck Serono SA, Vevey, Switzerland. He graduated from the University of Mainz as a Pharmacist in 1985 and obtaine... [ view bio ]

Novartis BioPharmOps site at Huningue (Alsace) was originally designed as a monoproduct facility. With the increased portfolio of biopharmaceutical products, the Huningue operation is undergoing... [ view bio ]

John Madsen received his Ph.D. in Biomedical Sciences from the University of Texas Health Science Center, Houston/MD Anderson Cancer Center, Department of Cell Biology. His post-doctoral work at ... [ view bio ]

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Reduction of time to market and risk is key in todays market dynamics. DSM BioSolutions has developed a fast-track scale-up approach: By application of a broad range of microbial expression syste... [ view bio ]

Recent contamination events with porcine circovirus, vesivirus and murine parvovirus have highlighted the necessity for implementing an integrated control strategy at biotechnological production.... [ view bio ]

The presentation introduces the Merck Serono Project “Large Scale Biotech Production”, the currently worldwide biggest investment project building a biotech production plant at the s... [ view bio ]

For our customers it is of utmost importance that we can always guarantee product quality as well as availability. The regulations of the agencies guard that the customer needs are met by means ... [ view bio ]

Irwin Hirsh has worked in the pharmaceutical filed since 1998 in many different capacities including lead compound discovery, development, production and quality. Before Joining NNE Pharmaplan I... [ view bio ]

The presentation describes the current Merck Serono QbD approach to the validation of a drug substance manufacturing process for an Fc fusion protein. The presentation will focus on the applicat... [ view bio ]

Tomoyuki (Tomo) Miyabayashi is currently Vice President of Science and Technology at Asahi Kasei Bioprocess Inc.. His responsibilities are to develop advanced technologies in bioprocess field and... [ view bio ]

BS Biochemistry. 10 years laboratory research and diagnostics regarding allergy at Sanquin, NL; Spent 16 years with Pharmacia Biotech (now GE Healthcare) developing engineering business in Europe... [ view bio ]

Steve has more than 20 years of leadership experience and joined Rapid Micro Biosystems from PerkinElmer Life and Analytical Sciences, where he most recently led a business with responsibility fo... [ view bio ]

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What is the safety level needed to handle the molecule of interest? Batch versus campaigns? Volume levels? All these types of questions will lead to a choice between re-usable or disposable techn... [ view bio ]

What is the safety level needed to handle the molecule of interest? Batch versus campaigns? Volume levels? All these types of questions will lead to a choice between re-usable or disposable techn... [ view bio ]

Continuous chromatographic processes are under repeated evaluation in the biopharmaceutical industry due to their advantages in therapeutic protein downstream processing which include high produc... [ view bio ]

Kit Erlebach (Head of Technical Operations) has a first degree from Nottingham University in Chemical Engineering and a PhD from Cambridge University in Chemical Engineering and is a Chartered Ch... [ view bio ]

Successful Quality by Design (QbD) requires effective collaboration between Process Development, Manufacturing and Quality Assurance teams which are often spread across multiple time zones and co... [ view bio ]

Single-use bio-processing applications are still in great need of reliable key process parameter measurements for pH, dissolved oxygen (DO), and temperature, as traditional electrochemical sensor... [ view bio ]

Currently, Grant Boldt oversees all the contract manufacturing business development activities at SAFC for both small and large molecules in the EU. He and his team have several years of experien... [ view bio ]