An Interview with Pall's Global Vaccine Market Manager Annelies Onraedt

An Interview with Pall’s Global Vaccine Market Manager Annelies Onraedt at World Vaccine Manufacturers China Summit 2014

Shanghai,China,27-28 March 2014 - World Vaccine Manufacturers China Summit 2014 was successfully held at Parkyard Hotel, Shanghai. During the summit, it’s a pleasure for our reporter Jason to have an interview with Pall’s Global Vaccine Market Manager Dr.Annelies Onraedt.

(Q will stand for reporter of Bio-equip for short.And A will stand for Dr.Annelies Onraedt in the following article.)

Q: According to your 2nd fiscal quarter report announced in Jan, the bio-pharmaceutical business of Pall has achieved 9% growth in which SUS products showed a solid increasing trend. What is your opinion on the contribution of Chinese market? What is the development status of bio-pharmaceutical business, especially vaccine and antibody business in China?

A: Chinese market is an important part of our global market.. And it is also one of the countries with a very high grow rate. The unchanged commitment of Pall is to continue investing in this market.

It has a large population and more than 16 million newborns per year（Source: National Bureau of Statistics of China）, high predicted GDP growth, and increasing per capita disposable income. These are all drivers of the growth of vaccine market in China. China has around 36 vaccine manufacturing plants (data China FDA). Quality of manufacturing is increasing, with the implementation of New GMP in China. Now, the National Regulatory Authority responsible for the vaccine product, China FDA (CFDA), is evaluated as "functional" by WHO. Chinese vaccine manufacturers can apply to get prequalified, which allows them to sell vaccines to UNICEF, the number one vaccine purchaser in the world and as such a great market opportunity. When Chinese vaccine manufacturers take up this challenge and work further to improve the quality of manufacturing and set this to international standards, in my opinion, we will soon found the players from China in global vaccine market, and they will have an increasing impact in the future.

The vaccine business is and will be an important contributor of Pall China Life Sciences business as well as a driver of growth.

Q: Since 2005, the annual growth rate of vaccine market in China has been exceeded 20%. What is the position of this market in Pall’s global strategy? And your expectation or prediction of this marketing？

（Source of data 2001-2012: SMEI (southern Medicine economic Institute) & NDRC (National Development and Reform Commission)； Data of 2013 & 2014: by estimation with the forecasted growth rate by thought leaders）

A: Talking about the expectation of vaccine market in China, as the global vaccine market manager of Pall, I hear first hand of the high speed growth and hear the voice on requirement of new process technology. No doubt that we wish to have Palls business grow with this industry altogether. It is very obvious that the drivers for vaccine market in China are not only the large and growing population but also and rather the push for process innovation and the overall need to make safer vaccines, of higher quality. Technical innovation is at the core of everything Pall does. This matches the model of the industry very much. Through many years practice of supplying process equipment and solution to vaccine companies to the world, as well as in China, Pall has gained recognition and trust as a partner.

Q: Pall has completed the acquisition of ATMI Life Science and SoloHill recently to enrich its product line. What changes will it bring to Pall?

A: Pall keeps focusing on the development of its Life Sciences business to best serve our customers, and continues to invest in the related areas. The recent acquisitions strengthen the capability of Pall in the upstream area regarding single-use bioreactor and preparation of culturing media and buffers. Adding the wider range of single-use mixing and compounding solution acquired from ATMI, and the advanced micro carrier products of SoloHill into Palls product portfolio will increase our coverage in bio-process, and will help solidify Pall as a total integrated solutions provider. And the ultimate beneficiaries from the professional one-stop service would be our vast end users and public receiving higher quality, safer, and lower cost drugs and vaccines.

Q: What is your view of SUS’s trend, especially in vaccine and antibody production area?

A: Vaccines are used to increase immunity by infant, children, teenager, adult and elder people, and most of them are used for prevention purpose in healthy individuals. So the safety and quality of these kinds of products are very important. In addition, many vaccines today are still based on culturing a potential pathogen, which is then inactivated in a later stage (like IPV or tetanus vaccines). Single use technology allows the manufacture of vaccines have totally closed and clean systems during cell culture, downstream purification and formulation and filling. It prevents the product to be contaminated through its environment, including operators, and, as such, improves the overall product quality & safety. A great example of this are Pall Kleenpak™ Sterile Connectors and Disconnectors, that have changed the way liquids can be sterile transferred and have been greatly adapted by the vaccine industry. Closed single-use systems also help to protect the environment and the operators from the pathogens that are cultured. Because the systems are single-use and typically gamma-irradiated, there are also no concerns of cross-contamination from one batch to another. And furthermore, single-use systems make vaccine manufacturing more flexible and quickly adaptable to emergency needs, as in case of pandemics. Adapting single-use technologies have allowed global vaccine manufacturers to achieve a higher standard of product quality. Going forward, it is my opinion that Chinese vaccine manufacturers will widely adopt single-use technologies and some of them are already doing so.

Q: The main players have launched their SUS products. What advantage does Pall have over its competitors? Do you have a plan to develop any new product, specially for Chinese market?

A: Pall pays a lot of attention to the technical innovation, the user friendly design, and the quality of it SUS products. All SUS products are designed based on Quality by Design (QbD) concepts and launched with a large validation package to ensure excellent customer value and the safety of the final vaccine products. Single-use systems are more than a set of plastic bags and tubings assembled together. In order for them to add to the vaccine product quality, users need to be able to install and operate the systems without errors. The materials in contact with the product have to be safe and qualified for extractables and leachables. And just like with stainless steel system, engineers need to assure that the system designed meets the user requirements, in terms of pressure rating or temperature compatibility. We are continuously developing and launching new products. Recently, we have launched the innovative Cadence™ Inline-concentrator and the excellent Allegro™ MVP system used for automation and operation control of SUS systems.

As the Chinese vaccine market is growing, we do listen to the requirements of the local vaccine manufacturers. However, it is our opinion that in order for them to be successful in a global market, they will want to use the same technology as elsewhere in the world. All our products are available to Chinese manufacturers immediately after their global launch. Where we are trying to add value is by expanding our local service to further help our customers implement our novel technology solutions and products. For this Pall recently opened a new and larger facility at our previously established center of excellence in Shanghai.

Q: What advantage do you think that Pall has in the field of downstream process of vaccine?

A: Pall is a top-qualified supplier of processing equipment to leading vaccine companies around the world. We can provide various proven mature outstanding products and well-validated technological solutions. For each downstream unit operation of vaccine production, including clarification, ultrafiltration concentration & diafiltration, sterile filtration and formulation & filling, we can supply powerful products proven by substantive application expertise. Some of our unique technology and product will help our customer to address both traditional and novel vaccine. Ion Exchange Chromatography on Mustang® Q XT Membranes can give good purification of influenza virus, for example, and the innovated Cadence In-line-concentrator can achieve quick and efficient concentration of fragile biologics. Furthermore, all of these products can be integrated into SUS systems, which will greatly add the value in safety, efficiency and total manufacturing cost.

Q: There are many R&D organizations for vaccine in China, what could Pall provide for them?

A: Vaccine research is focusing on getting new vaccine concepts, giving a better immune response or targeting new diseases, to the market fast. There is still a big gap between researchers and manufacturers which can slow down the process of vaccine approval and commercialization. We offer our technologies and expertise to these organisations to enable them to facilitate this new vaccine development process. This by providing scalable tools for all our technologies so that results achieved at research scale can be reproduced on manufacturing level meeting regulatory requirements for quality and safety. We also have tools that enable high throughput screening, example is the Micro-24 bioreactor system, which allows for simultaneaous screening of 24 cell culture growth conditions, in a small volume of 7 mL only. High throughput screening allows researchers to rapidly explore a wider range of conditions, so that the final process decisions are based on decent investigation. And Pall now also has some interesting analytical technologies in its portfolio, one of them being Fortebio’s BLI method for detecting and qualifying antibody-antigen interactions, implemented in the Octet® system and the Blitz® system. Researchers are very excited about the possibilities for protein, virus and other molecule quantification, stability evaluation and many more possibilities this technology brings them.

Q: Lastly, would you like to say some words to people in life science industry in China? What did China impress you the most?

A: Their extensive knowledge, outstanding operation skill and dedicated attitude impressed me the most. They are talented, capable and proactive which sharp them very aggressive.

Besides, the development of Chinese biopharmaceutical industry also gives me a deep impression. I firmly believe that Pall can create more values to our distinguished Chinese clients with its 60+ years abundant experience in bioprocessing area as well as its cutting-edged products and services!

Bio-equip’s reporter Jason and Dr.Annelies Onraedt at the Pall’s booth

After the interview, Dr. Annelies Onraedt led us to Pall’s booth and itroduced Pall’s products such as XRS 20 Bioreactor System.

About Pall
Pall Corporation is a global leader in the high-tech filtration, separation and purification industry. We’ve become an industry leader by helping customers solve complex fluid management challenges.

Pall’s fluid management capabilities span markets and the applications within them. We are leveraging over six decades of scientific and engineering knowledge, applications experience and a vast technology and product portfolio to help make customers more successful. In turn, they reward us with business that repeats and grows with them.

To learn more about Pall, please visit www.pall.com/green.