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Manufacture Contract Manufacturing Services

The Customer View

sponsored by MilliporeSigma

Tell us about Samsung Biologics and how the company is growing…

In 2007, Samsung’s Chairman, Lee Kunhee, organized a special task force team to discover Samsung’s next-generation growth engine. Samsung’s executive team nominated CEO, Dr. TH Kim, as the one responsible for finding this new growth. Dr. Kim spent 3 years with a team to review dozens of new business candidates, including solar cells, electric cars and so on, but he finally selected biopharmaceuticals to become the new business of Samsung.

Samsung Biologics was established in April 2011. Everything in the biopharma industry is a first experience for Samsung. We decided to build our first plant to a standard size – around 30,000 L capacity. We built this first plant in 13 months and it took 25 months to receive approval from regulatory authorities. Our clients were very satisfied with our services, and since the first plant we have built two more facilities (150,000 L and 180,000 L) over the past 4 years. We have also expanded the scope of services to include development. We can now provide solutions to our clients from cell line development to manufacturing in one site.

But we are not satisfied with where we are now. We will continue to expand our business both for clients and shareholders. We are so excited to be a world class biopharmaceutical company that will cover all value chains in the near future!

How did you come to collaborate with the M Lab™ Collaboration Centers?

Samsung Biologics initiated its first GMP product manufacturing in Plant 1 in 2014 – just three years after the company’s foundation. Although we had experienced experts from around the globe in key areas of manufacturing operations and technical support, the majority of our employees were quite new to this industry. At the same time, Plant 2 was under construction and we anticipated an increased number of batch output and tech transfers in the following years.

The hands-on courses offered at the M Lab™ Collaboration Center are top-rated courses among our employees in terms of the learning environment, curriculum, and trainer knowledge and expertise.

As a CMO company, we faced challenges with manufacturing processes that are being transferred from each client, with variations in raw materials, equipment and facility variations. We wanted professional expertise to overcome the challenges, and we also felt that training was required to enable our new employees to develop their capabilities – this was a key element of growth for the Korean biologics industry.

We under took an initiative with the Korean government to establish a research and training center, similar to Ireland’s National Institute for Bioprocessing Research and Training (NIBRT) to develop a qualified industry resource pool in Korea. We worked with several partner companies to establish application development /process development, and training capability in the country to help troubleshoot and provide customized in-depth training around raw materials, equipment and manufacturing processing.

MilliporeSigma was an early member who recognized the challenges we faced and they knew the industry trends and needs around the globe. MilliporeSigma finally opened the M Lab™ Collaboration Center in Songdo, Korea, in 2016.

The Training Challenge

With Charles Park, Manager, Manufacturing Science and Technology at MilliporeSigma.

One of the biggest challenges that biopharmaceutical companies have is adequately training new employees. Even though new people may have a bio-related education, they will no doubt have much to learn about applying this in practice and will need training. Some companies try to prepare training with their own internal resources, but this can become a burden. Asia has seen a dynamic increase in the number of projects transitioning to the clinical phase in the last two to three years, which means more skilled labor is required.

Samsung Biologics has been growing fast with a strong focus on the market – and is now considered the world’s largest biopharmaceutical CMO company. When Samsung’s needs were growing, we opened our M Lab™ Collaboration Center in Songdo. I was involved in the customized training program for Samsung, which is an ongoing partnership today.

Samsung had three main requirements. First, they needed targeted content for the audience, including risk assessment and troubleshooting for the engineers, and optimization and tech transfer for R&D. Second, they requested different course levels based on trainees’ experience level – basic and advanced training. Lastly, there was a requirement for hands-on experience for trainees to adapt to the field more quickly. To meet these demands, we customized the training classes. We provided automatic filter integrity testing and normal flow filtration training for engineers, and clarification and tangential flow filtration for process optimization. These trainings combined hands-on experience with the required theory sessions. For all handson training courses, we utilized workshop sessions that allowed us to discuss, in depth, test results, troubleshooting and any risks that might happen in the real process.

The feedback from Samsung has been very positive and constructive. After attending sessions in the M Lab™ Collaboration Center, trainees became more confident about their work. I’ve been very proud of the trainees’ proactive attitude; they were active participants and found the training so useful that they recommended it to their colleagues. It’s a great motivation for me! And this is just the beginning…

What type of training did MilliporeSigma develop for Samsung?

Under standing biomanufacturing processes is fundamental for CMOs. Some might think that technical training is not so important for operators that are manufacturing client products, but this is wrong. Training is crucial for everyone who is involved in biomanufacturing, from upstream to downstream and final fill. And continuous education of our workforce is one of the critical factors that allows us to be a reliable partner to our customers.

MilliporeSigma developed customized training courses focused on filtration and integrity testing. Other topics included singleuse technologies and chromatography. They offered these technical trainings in different levels (basic and advanced) and different types (theory and hands-on) designed for diverse audiences with different levels of experience. The hands-on courses offered at the M Lab™ Collaboration Center are top-rated courses among our employees in terms of the learning environment, curriculum, and trainer knowledge and expertise.

Did You Know?

  • There are more than 50 inhouse certified trainers in the M Lab™ Collaboration Centers worldwide.
  • Customers can take a range of biopharmaceutical and classical pharma courses at the M Lab™ Collaboration Centers, from upstream to downstream and formulation.
  • Both hands-on training and classroom-style theory courses are offered in our M Lab™ Collaboration Centers around the world.
  • The M Lab™ Collaboration Centers also provide focused training on MilliporeSigma products to help customers optimally implement them in their production setting and reduce the need for technical support.
  • As an extension of our M Lab™ Collaboration Center services, our team of experts also delivers customized training directly at the customer site.

Learn more at www.emdmillipore.com/training

The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada.

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