Developing Practical Single-Use Processes for New Vaccine Formulations
16th May 2017 | 10AM EST | Kirsten Strahlendorf of Sanofi Pasteur |WATCH FOR FREE
10:00 am Eastern Standard Time
3:00 pm Greenwich Mean Time
4:00 pm Central European Time
7:30 pm Indian Standard Time
10:00 pm Singapore Standard Time
New vaccine process designs – and all the kinks that go with them – are typically hammered out in a small scale capacity, for example, prior to manufacturing for early phase human clinical trials. They are then upsized and further defined for industrial scale to supply the vast market. Single-use technologies (SUTs) have been a hot topic for several years now and their advantages well-known: easy product changeover, processing in lower classification areas, reduced CAPEX, elimination of glass, sterility assurance, to name a few. In vaccine manufacturing, SUTs are used throughout the processing stages, from cell culture all the way to filling. SUTs are quickly and conveniently designed, purchased and implemented for short-term manufacturing of clinical trial phase materials. Here a large percentage of new vaccines in Research and Development do not even make it to market.
As the final production stages are critical as they are the last stages before patient injection, the scope of thisarticle covers SU applications involving drug substance formulations, adjuvant processing, final bulk formulation and filling. The actual process itself may include some or all of the following: filtration, pumping, ingredient addition, mixing, adsorption, filling, labelling, sampling and and storage.
In this presentation only liquid formulations (“presentations”) will be discussed.
Presented by Kirsten Strahlendorf of Sanofi Pasteur
For the last 11 years, Kirsten Strahlendorf has been working as a Senior Scientist in Research and Development at Sanofi Pasteur in Toronto. She holds a Professional Engineering license and an honours degree in Biological Engineering from the University of Guelph. Very recently, she has graduated from the University of Toronto with a degree in Master’s of Engineering achieving the highest grade point average attainable.
Kirsten takes a seat on the Board of Directors for the Bio-Process Systems Alliance. A driver in the bioprocessing community, she has published several journal articles. Kirsten manages a bioprocess design and scale-up laboratory for vaccine formulations. Her focus lies in automation and isolation systems for novel biotechnology products decades away from being marketed.
In her personal life, Kirsten enjoys her three small children who understand that their mother makes “needles with medicine” for work.
Sponsored by Pall
END TO END SINGLE USE SOLUTIONS IN FORMULATION AND FILLING PROCESSES
Formulation and filling processes represent one of the most challenging applications in bioprocessing. Obviously, when single use is the technology of choice, the supplier needs to focus heavily on quality by design and stringent quality processes in order to ensure the delivery of safe drugs to the patient.
In the presentation, we will show how by adopting these concepts from single use systems design to implementation, we are currently delivering robust single use formulation and filling processes to the bioprocessing industry. In addition, we will discuss our approach to the design and implementation of single use automated solutions will contribute to further enhance the safety of novel drugs.
Presented by Dr Hélène Pora of Pall Life Sciences
Dr Hélène Pora is Vice President Single Use Technology within Pall Life Sciences, where she has the global responsibility for the marketing and development of Pall single use technologies. Hélène has been instrumental in the development of Pall single use technologies for the last 20 years. She is as well heavily involved in quality and regulatory aspects of single use technology. Hélène has over 30 years of experience working for the biopharmaceutical industry, the last 26 years within Pall Corporation.
She speaks regularly at conferences about single use technology with a strong focus on validation and over all process integration aspects, she is as well involved in different working groups in the industry involved in standards development and is on the board of BPSA and SUTAP.