SERACH RESULTS FOR" Research "
research), making it easier to understand the company’s end-to-end business capabilities. Industry professionals and job seekers can also get an insight into the working environment and the numerous benefits offered at SBL, and interested candidates can submit their information to the SBL Talent Pool via the website. “For the past eight years, our company has been on a record-pacing journey of growth and innovation, and as our business capabilities and client services continues to evolve, it is crucial that our clients, prospective candidates, and anyone with a vested interest in Samsung Biologics be able to quickly find the information they are seeking and understand our value proposition via our website. We are excited to announce that the launch of our new website was enabled by innovative information technology and interface design tailored to optimize end-user experience,” said a company representative.
CytoDyn and Samsung BioLogics Formalize Manufacturing Partnership Dr. Tae Han Kim, CEO of Samsung BioLogics and Dr. Nader Pourhassan, CEO of CytoDyn INCHEON, S. Korea, 30 May 2019 - CytoDyn Inc., a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications and Samsung BioLogics met at the Samsung BioLogics Songdo headquarters for an official signing ceremony of the manufacturing agreement with Samsung BioLogics that was previously announced on April 2, 2019. The signing ceremony was attended by Nader Pourhassan, Ph.D., CytoDyn’s President and CEO, along with Nitya Ray, Ph.D., CytoDyn’s Chief Technology Officer, and hosted by top management of Samsung BioLogics, including Dr. Tae Han Kim, Samsung BioLogics CEO, along with John Rim, EVP, Head of Contract Manufacturing, James Park, SVP Head of Global Business Development and other members of the Samsung BioLogics leadership team. "We are excited to work with Samsung BioLogics, one of the world's best CMO firms. Given the company has consistently demonstrated an extremely high level of quality assurance, capacity, and cost effectiveness, we expect that we will be able to market our new drug quickly following an expected approval," stated Nader Pourhassan, Ph.D, CytoDyn’s President, CEO and director. “It is important for our shareholders to realize that our partnership with Samsung is the first step in validating what we have accomplished and the future potential for leronlimab,” continued Dr. Pourhassan. “One of our major strategic challenges with leronlimab’s sales potential as a monotherapy (provided we obtain approval) was to ensure we have sufficient large scale biologics manufacturing capacity in place to meet the expected demand and our Samsung agreement now successfully satisfies this long-term strategic requirement,” concluded Dr. Pourhassan. “Samsung BioLogics is very excited to be partnering with CytoDyn to bring this potential blockbuster drug to the market. It is clear that leronlimab and the CytoDyn team have an opportunity to bring significantly improved care to HIV patients around the world. Samsung BioLogics is proud to support this effort by providing a stable supply of only the highest quality product,” said Dr. Tae Han Kim, CEO of Samsung BioLogics. Dr. Nader Pourhassan (Left), CEO of CytoDyn and Dr. Tae Han Kim, CEO of Samsung BioLogics The signing ceremony was capped by a tour of the Samsung BioLogics campus including the Plant 2 VIP showroom and a window tour of Plant 3, Samsung BioLogics’ latest state-of-the-art manufacturing facility optimized for high volume products such as leronlimab. About Leronlimab (PRO 140) The U.S. Food and Drug Administration (FDA) has granted a “Fast Track” designation to leronlimab as a combination therapy with HAART for HIV-infected patients and for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling. Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. In the setting of HIV/AIDS, leronlimab belongs to a new class of therapeutics called viral-entry inhibitors; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use. In the setting of c
research and development work, coupled with its quality, technology and innovation, will establish a new global standard for best practices within biopharmaceutical manufacturing. Samsung BioLogics Facility Live ShowTitle: Samsung BioLogics Manufacturing LIVEDate: 6/5(Wed) 11:00, 14:00Presenter: Kevin Sharp We look forward to seeing you at the event. To schedule a meeting, please contact us at email@example.com
research), CDO (contract development) and CMO (contract manufacturing), biopharmaceutical companies will dramatically reduce costs and time,” said Dr. Tae Han Kim, “We will do our best to help domestic bio-venture companies, including GI Innovation, advance into the global market and commercialize their products through our CDO technology." "Thanks to Samsung BioLogics’ CDMO business, we can overcome the problem of producing high quality clinical test samples, the biggest barrier of bio venture companies,” said Dr. Nam, “We are very positive that global pharmaceutical companies interested in the R&D pipeline of GI Innovation will be able to access global new drug licensing (BLA) and biotech drug business through Samsung BioLogics' CDMO service. Through this collaboration, we wish to demonstrate the win-win model of venture firms and large corporations that the people and the government want.”
Research, for the third consecutive year sweeping all six categories including quality, capacity, stability, professionalism, compatibility, and service.The company was also selected as one of the "Future 50" companies by Fortune in October last year in recognition of its prospects for long term growth and global competitiveness.
Research (ISR) to determine the award recipients. More than 120 contract manufactures were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey. Survey participants were recruited from Pharma and Biopharma companies of all sizes and were screened for decision-making influence related to working with contract manufacturing suppliers. Respondents only evaluate companies with which they have worked on an outsourced project within the past 18 months. This level of qualification ensures that survey responses are based on actual involvement with contract manufacturers and clear experiential data."Samsung BioLogics is honored to be recognized once again as a top-performing CMO by CMO Leadership Awards, which identifies the reputable partner for global customer’s manufacturing needs. It is a great privilege to achieve the top ranking in all six award criteria for three years in a row and to attest to our solid position as a one-stop CDMO service provider for mammalian biopharmaceutical products through our flexible and state of-the-art facilities,” said TH Kim, CEO of Samsung BioLogic. “We continuously strive to provide quality-driven cGMP manufacturing services and to change the paradigm of biopharmaceutical industry for client and patient satisfaction.”Samsung BioLogics, being responsible from clinical development to commercial manufacturing, aims to strengthen its presence in the rapidly growing global biopharmaceutical market by utilizing its world-class plant design and operation technology that maximizes production efficiency and ensures highest quality products for the patient.
Research is honored to conduct the market research for Life Science Leader’s CMO Awards. ISR’s stringent screening processes and the high caliber of qualification required to participate in our contract manufacturing benchmarking market research means that real customers provide experiential feedback on their involvement with contract suppliers over the past 18 months. This enables users of ISR’s market research to make confident business decisions based on the experiences of their industry peers.” Andrew Schafer, President of Industry Standard Research. "Samsung BioLogics is honored to once again receive the CMO Leadership Award, which recognizes the reputable partner for global customer’s manufacturing needs. Being recognized in all core criteria – capabilities, compatibility, expertise, quality, reliability and service – attests to our solid position as a one stop service provider for mammalian biopharmaceutical products through our flexible and state of-the-art facilities,” said TH Kim, CEO of Samsung BioLogic. “We'll continue to provide quality-driven cGMP manufacturing for flexible and cost-effective services that exceed our customers’ expectations.” Samsung BioLogics, being responsible from clinical development to commercial manufacturing, aims to strengthen its presence in the rapidly growing global biopharmaceutical market by utilizing its world-class plant design and operation technology that maximizes production efficiency and ensures highest quality products for the patient. Samsung BioLogics’ Plant 3 facility was mechanically completed last November. It has 180,000 liters capacity and is expected to be cGMP operational by Q4 2018. -E N D –
researchers participate to share their opinion. Nicholas Beaumont, vice president of Quality Assurance team of Samsung BioLogics, participated in the event as a panelist and a facilitator for round table discussions. Nick said “Samsung BioLogics has been recognized in many global events which demonstrates the company’s manufacturing innovation and quality competitiveness”. He added that “Samsung BioLogics will continue to innovate to become the leading global CMO that manufactures the highest quality biologics. Additionally Samsung BioLogics received EMA approval last December, two months after FDA approval for plant 2. Samsung BioLogics said “By utilizing latest world-class facilities to both maximize production efficiency and strive for continual innovation to manufacture high quality biologics with competitive price, Samsung aims to provide a one stop contract manufacturing service and be the best CMO in the world.” Samsung BioLogics’ third plant was completed last November with a capacity of 180,000 liters and will begin operation in the fourth quarter of this year after validation. Upon the operation of its third plant in 2018, Samsung BioLogics is expected to become the world’s largest contract manufacturing organization (CMO) for biologics, with a total production capacity of 362,000 liters. – E N D –
research company, the most important factor for clients to choose CMOs is its ability to ‘stick to schedule’. The reason ‘stick to schedule’ is important is that as the competition in the biopharmaceutical industry is becoming intense, it is important to advance into the market and preempt it. However there are more than 10 steps from CMO contract to tech transfer, inspection and production, which takes more than 4 years. Also the cost for clients during this period is about 20 million to 30 million dollars. Successful certification is the most important factor to stick to schedule as product release gets delayed if approval fails. Samsung BioLogics has significantly shortened the period of approval and allows the clients to quickly supply their products to the market in a timely manner.Samsung BioLogics has received 11 manufacturing approvals from US, Europe, and Japan, which are the top three global bio markets in merely six years since the establishment. The company has won 15 products manufacturing orders from 10 pharmaceutical companies including BMS and Roche. On the other hand, plant No. 3, which was completed last month, has 180K capacity and Samsung BioLogics is expected to become the world’s largest CMO with the total production capacity of 362K liters. Tae Han Kim, CEO and President of Samsung BioLogics, said “Samsung BioLogics has proved once again that it possesses world class capability in quality as well as the production scales” and “We will continue to do our best to continuously innovate ourselves so that clients and patients can received medical products in a timely manner”.
research firm "EvaluatePharma" estimates the annual growth rate of the biopharmaceutical market will be 9.5% for the next 5 years. Amidst these market trends, global pharmaceutical companies are expected to focus internal resources on R&D and marketing while outsourcing manufacturing work to CMOs, resulting in an increased demand for the CMO industry. In this industry, it is extremely important to accurately read changes in the market, and be able to predict the upcoming trends.From its inception, Samsung Biologics has been thoroughly analyzing the market supply and demand. Based on the analysis, we have predicted a shortage in supply and boldly decided to invest in large scale capacity, which established SBL as a successful player in the Bio CMO market. Through long-term partnerships with global pharmaceutical companies, we have made great achievements within a very short time frame.Last year, Samsung Biologics secured a stable funding structure to support future growth, via its successful IPO. Now, I would like to talk about our latest business achievements. Samsung Biologics has signed nine CMO contracts with six global pharmaceutical companies, and we are currently under negotiations with fifteen pharmaceutical companies to produce over thirty products. Plant 1, which began commercial operation in 2015, was successfully approved by the FDA and EMA, and has been recorded a surplus in operating income since last year. Plant 2, which is the world's largest mammalian cell culture plant, is ramping up to prepare for full production and is expected to also record a surplus in operating income.Plant 3, poised to become the most competitive plant in the world, has recorded construction progress of 70%, will be mechanically complete by Q4 this year, and will begin GMP operation by Q4 next year. Owing to our competitiveness in construction, production, and quality, Samsung Biologics is achieving improved performance in key metrics such as revenue and operating income. Last year, we recorded revenue of 294.6billion won, a 223% increase from the previous year. Samsung Biologics has already become a leading company in the CMO industry, thanks to our hard work these past 5 years. However, we will not stop here. We will challenge ourselves to become a "Game Changer" in the biopharmaceutical industry. We will bring up the share of CMO production in the biopharmaceutical market from 25% to 50%.2017 will be a very important turning point.Samsung Biologics will make sure to achieve top client satisfaction and innovation in productivity through our "Breakthrough-21 Management Innovation" activities.Also, we will expand our business portfolio to encompass Contract Development Organization R&D services which will reinforce Samsung BioLogics’ technology capability for a sustainable growth. Samsung Biologics strives to increase the value for our shareholders by pursuing sustainable growth and high profit margins in a fast-growing global biopharmaceutical market.Also, as a newly listed public company, Samsung Biologics will contribute to national economic development through transparent and ethical management, and to our national and local community through creating high-value-adding jobs. We ask for your continued support this year, and promise that we the employees will return the favor with enhanced value for our shareholders. Lastly, I ask for your cooperation in making today's assembly a productive one. Thank you. Respectfully yours, Tae Han KimPresident & CEO, Samsung Biologics Co., Ltd
research conducted with Industry Standard Research (ISR). More than 80 contract
manufacturers around the world were assessed by 30 performance metrics in ISR’s
annual Contract Manufacturing Quality Benchmarking survey to determine winners
in the six categories. The survey questioned those from pharmaceutical and biopharmaceutical
companies of all sizes and were screened for decision-making related to working
with contract manufacturing suppliers. They were asked questions about their
perception of suppliers.
research into technology innovation as it aims to become a global top-tier biopharmaceutical manufacturing company. Samsung BioLogics will select lead managers for the IPO next month to decide on the exact timing of the listing and the volume of shares to be offered. "We are pleased with our sustainable expansion through continuous investments and innovation,” said Dr. TH Kim, CEO of Samsung BioLogics. "We will continue to strengthen our competitiveness in order to deliver long-term growth and create meaningful value to our customers and shareholders.” The global biopharmaceutical industry is expected to expand to almost $278 billion by 2020, with an annual growth rate of more than 8% on average, according to a World Preview 2015 report by research firm Evaluate Pharma, amid an aging population and the development of medical technology. Samsung BioLogics aims to strengthen its presence in the rapidly growing global biopharmaceutical market by utilizing its world-class plant design and operation technology that maximizes production efficiency. Samsung BioLogics is investing a total 850 billion won in its third plant with a capacity of 180,000 liters, which is expected to be completed by 2017 and begin operation in the fourth quarter of 2018 after validation. Once in operation in 2018, Samsung BioLogics is expected to become the world’s largest contract manufacturing organization (CMO) for biologics, with a total production capacity of 360,000 liters. These materials are not an offer for sale of the securities of Samsung BioLogics Co., Ltd. in the United States. The securities may not be offered or sold in the United States absent registration with the U.S. Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended. Samsung BioLogics Co., Ltd. does not intend to register any offering in the United States or to conduct a public offering of securities in the United States. Not for distribution in the United States.
research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, Merck Millipore serves as a strategic partner to customers and helps advance the promise of life science.Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 66 countries and 2013 revenues of € 2.6 billion. Merck Millipore operates as EMD Millipore in the U.S. and Canada.Note: Merck KGaA or Merck shall mean Merck KGaA, Darmstadt, Germany.
Samsung BioLogics (hereinafter, the “Company”) values users’ personal information, complies with statutory obligation s on protection of personal information such as the Act on Promotion of Information and Communication Network Utilization and Information Protection, etc. and the Act on Protection of Personal Information, and has created a Policy to Handle (Process) Personal Information to protect the users’ right and interest to the maximum extent possible.
Through the Policy to Handle (Process) Personal Information, the Company publicizes its operations on personal information treatment (processing) with particulars such as the types of personal information collected from the users and the purpose of processing such information, the time limit for processing and holding in possession, users’ method to exercise their rights, measures to procure the security, and so on.
Whenever there is a change in the Policy to Handle (Process) Personal Information, including updating, deleting, or adding its contents, whether resulting from any amendment to the relevant statutory sources or the administrative policy or change in the Company’s internal policy, we will post the change on our website at www.samsungbiologics. com so as to keep the users updated.
The Company’s Policy to Handle (Proce ss) Personal Information contains the following:
The Company collects personal information for the following purposes. The pfi will not be used for any other purpose and whenever it is necessary to change the purpose, we will comply with the statutory requirements such as obtaining users’ consents in advance.
Review and reply to the inquiries from users
Check employment history, give notices for future recruitment opportunities.
|Required||Name, Email Address, Company, Occupation, Country, Areas of Interest|
|Optional||Job Title, Phone Number|
The following information may be generated and collected in the course of using the service.
Access long, cookie
Collection through Contact Us, Talent Pool within the Website
Collection through generated information collection tool (for access long, cookie, etc.)
Personal information that needs to be collected and utilized inevitably as specifically required by law or regulations, or in order to comply with statutory requirements : As long as it is necessary to keep such information in possession under relevant statute.
Personal information that needs to be collected and utilized inevitably in order to execute and perform various contracts: Until the purpose of collection/utilization is accomplished.
Personal information collected and used with the consent of individual user: For the time period consented to.
If the user has given his/her consent in advance.
If it is specifically required by laws or regulations or inevitable in order to comply with statutory requirements, or if it is deemed necessary for the sake of life, body or property of the information owner or a third party when the information owner or his/her legal representative is under a state incapable of communication or unable to give consent due to unknown domiciles or otherwise (only to the extent the purpose of collecting personal information is served).
User’s personal information
History of the users personal information being utilized or provided to a third party
History of consents given to collection, utilization and provision of personal information
If it is specifically required by laws or regulations or inevitable in order to comply with statutory requirements.
If it is likely to jeopardize a person’s life or body or unjustly infringe a person’s property or other interests.
The Company is operating cookies that regularly stores and locates users’ information.
How to install cookies (if using Internet explorer 8.0) Select “Internet Option” in the “Tool”. Click “Privacy” tab. Using “Setting”, users may set the level of allowing cookies as suitable for their own needs.
How to view the cookie received (if using Internet explorer 8.0)
Select “Internet Option” in the “Tool”. Click “General” tab and select “Setting” of the Browsing History to check the files in “View Files”.
How to disallow cookie installation (if using Internet explorer 8.0) Select “Internet Option” in the “Tool”. Click “Privacy” tab. Using “Setting”, set it to the higher level, that is, “Block All Cookies”
in handling users’personal information, the Company endeavors to keep the personal information from being lost, stolen, revealed, tampered or damaged. To this end, the following technical and managerial actions are taken.
The Company implements its own internal management plan to secure safety in processing the personal information.
The Company is operating an internal organization dedicated to personal information protection to monitor the status of compliance with the personal information protective requirements and the responsible staff’s duty performance and takes corrective measures when any irregularity is found.
Installation and operation of access restriction device Using the intrusion blocking system, the Company controls any unauthorized access from outside and endeavors to procure all the technological system to the maximum extent feasible in order to secure systematic security.
Minimized designation of personal information processors and education The Company minimizes designation of personal information processors and implements internal and/or outsourced education on a regular basis. Personal information processors’ duty handover is conducted with the security fully maintained and their responsibilities for any personal information accident are clearly defined even after they have left the Company.
Restrictions on access to personal information The Company places restrictions on access to personal information through granting, changing or revoking the right to access to database system that processes personal information. We also record the history of granting, changing or revoking the right, which are retained for our records for at least three years.
The personal information of users is protected by the password and the file and transmission data are encrypted or stored by using file lock function. More important data are protected through certain separate security measures.
The Company has adopted security devices that enable safe transmission of personal information on the network using encryption algorithm.
To safeguard personal information from leak or loss by hackers or computer viruses, the Company has installed a security program and conducts periodic updating and reviewing.
For unmistakable security operation, every server is installed with intrusion blocking system as a means to block outsider intrusion by hacking as well as a system to analyze vulnerability.
To protect users’personal information and handle personal information-related customer complaint, the Company has appointed a personal information manager and processor. Any inquiry related to personal information protection and management should be directed to the personal information processor for instant and adequate reply.
Division: General Affairs Security Part, Personnel Management Team
Any user seeking to relief from personal information infringement may apply for resolution or consultation to Personal Information Dispute Mediation Committee, Korea Internet and Security Agency (Personal Information Grievance Center). In addition, users may contact the following institutions to be consulted on personal information infringement cases.
Personal Information Dispute Mediation Committee (118)
Korea Internet and Security Agency (Personal Information Grievance Center)(www.kopico.or.kr/1336)
Information Protection Mark Verification Committee (http://eprivacy.or.kr/02-580-0533~4)
Internet Crime Investigation Center of the Supreme Prosecutors’ Office
Cyber Police Agency (www.police.go.kr/1566-0112)
Personal information Protection Committee (http://privacy.kisa.or.kr/kor/main.jsp)/02-2180-3000)
When this ‘Policy to Handle (Process) Personal Information’ needs to be changed to reflect the change in statutory sources or government policies, we will put such change in public notice through an advisory statement and a separate window on the website.
Your valuable comments contribute to protecting Samsung Biologic’s core technology and management information, as well as reinforcing domestic competency and economic development.