BioPharm

www.biopharminternational.com March 2018 BioPharm International eBook 25 Outsourcing Resources Contract Biomanufacturing transition point due to advances i n ge nome s c ie nc e. T he r apie s were needed to treat disease con- ditions of an aging global popu- lation and the dr ugs had to be affordable. BIO DIVERSIFICATION "What could be the major indus- t r y w h i c h c o u l d l e a d f u t u r e g lo b a l i nd u s t r y? I t ho u g ht it could be the healthcare industry in addition to the IT industr y," K im told BioPharm International. "Of course, the healthcare indus- t r y evolut ion i s ba s e d on t he powerful information technology. For example, you cannot develop genome science without informa- tion technology." For biopharma to emerge as a force in adva nced ma nu fac t u r- ing, however, the industry needed to learn some lessons from other industries. Most people develop- ing biopharma facilities are from the biopharma industry and lack exposure to practices from other industries, Kim said. While other industries such as aerospace, ship building, chemi- cal, semiconductors, automobile, or steel use concurrent processing to construct facilities, biopharma uses step-by-step processes to build bioprocessing plants. "In conventional step -by-step processes, you spend six months f o r b a s i c d e s i g n a n d s p e n d another six months for detailed design. And you spend three to fou r mont h s for pr o c u r e me nt of equ ipment. T hen you bu i ld a b u i ld i ng. T he n you have to fabr icate. You have to validate. T hat 's why t hey need t he f ive years or six years," he explained. "In parallel processing or concur- rent processing, you put as many processes in parallel as possible so that you can reduce the time- line." T he r e a r e t wo r e a s o n s b io - pharma companies are slow to adopt innovative practices. First, he says, the profit in biopharma industry is very large and the cost of goods is t y pically less than 10% of the revenue. "So even if you innovate dramatically for the ma nu fac t u r i ng pro cesses, you are talking about 10% of a rev- enue. From the CEO and manage- ment point of view, innovation in manufacturing has not been very valuable. They have been more interested in discovery, develop- ment, marketing, and sales," he said. The second reason—a compli- cated reg ulator y env ironment— c a u s e s b io p h a r m a c o mp a n i e s to take a relatively conservative approach to adopting innovative ideas. IDENTIFYING A COMPETITIVE EDGE Kim was convinced that Samsung could be not only an IT-oriented company but also a healthcare and biotech company. After analyzing supply and demand opportunities and evaluating the industry attrac- t iveness a nd compet it ive env i- ronment, the company targeted c o nt r a c t m a n u f a c t u r i n g a n d biosimilar development versus the innovator drug route. The high value nature of the novel biologics drug market makes it at t rac t ive, he sa id; however, thousands of small biotech com- panies, plus Big Pharma companies compete in the drug discovery and development arena. Only a few large biologics contract manufac- turers and approximately 80 small contract manufacturing organiza- tions (CMOs), served the industry. He believed that Samsung could compete against and catch up to the capabilities of the big CMOs in a short time. "In addition to the attractiveness of the CMO industry, I could be more competitive in the CMO industr y from the view point of quality and compliance," he said. The company's construction capabilities and ability to reduce capital expenditures and the construction timelines could lead to client satisfaction, he said. BIG PLANTS, RAPID DEPLOYMENT The company was formed in April 2011 in Incheon, South Korea as a joint venture between Samsung affiliate companies and Quintiles Transnational Corp. To date, the company has invested approx i- mately $1.7 billion in three manu- facturing facilities for monoclonal antibody (mAb) dr ug substance and drug product. The company's first plant, with 30,0 0 0 -L of bioreactor capacit y, received FDA approval 25 months after the plant started operation; full commercial operation began in November 2015. The facilit y is also certified by the European Me d ic i ne s A ge nc y ( E M A) a nd J a p a n's P h a r m a c e u t i c a l s a n d Medical Devices Agency. The second plant for mAb manu- facturing— currently the world's largest single plant—is five times larger than the first plant, fea- tures 10 bioreactors with 152,000-L c a p a c i t y, a n d r e c e i v e d F DA approval in 19 months, in October A complicated regulatory environment causes biopharma to take a conservative approach to adopting innovative ideas.

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