monoclonal antibodies. ADCs can be unstable in the liquid state, for example. Triin Jurgenson, senior scientist in ADC process development in Kim’s team, puts it like this: “In order to produce more homogeneous ADCs, the conjugation process tends to become more complex.”End-to-endAt Samsung Biologics, expertise in EPCV (engineering, procurement, construction, and validation) and prioritization of safety protocols for handling toxins, such as isolators and fume hoods, make for a smooth transition into the new venture.Located across Bio Campuses I and II at in a separate location, the four-story standalone facility at Samsung Biologics allows for ADC conjugation right near where the antibodies are made. “It can be that at a given CDMO, the antibodies are manufactured separately, conjugation is carried out separately, and the drug product is made separately,” says Ryuryun Kim, lead scientist in ADC process development. What ensure the quality, safety, and efficacy of ADCs, according to Thomas Rohrer, Senior Director of Technical Support for Bioconjugates, are meticulous analytical capability and a flexible manufacturing environment that can adapt to the changing conjugation chemistries required in the next generation of ADCs. “Samsung Biologics has the ability to engineer the targeting agent to improve the specificity, ADCC response, and homogeneity of the ADC,” he says. Based in Washington D.C. and working with the Samsung Biologics America team in New Jersey and the campus in Songdo, Rohrer envisions a “one-stop shop.” He believes such a vision is possible with Samsung Biologics’ new ADC facility, with process development and manufacturing experience paired with advanced analytical services to support ambitious timelines for drug product delivery. World-class analytical technology for characterization and stability complements ADC drug substance and product manufacturing capability.Driven by this shared goal, the Samsung Biologics ADC team has been setting up experiments around the clock to kick-start prospective clients’ projects, run validations, and study standard operating procedures to determine feasibility. The global CDMO has the ability to perform stability analyses of the drug substance and drug product to ensure that ADCs maintain their integrity and efficacy from early clinical phase to commercial manufacturing. Comprehensive analytical techniques allow the team to identify the structural robustness and monitor intermediate samples from process development and manufacturing.One TeamSenior scientist in ADC analytical development Seokho Hong commends his team members for fostering a healthy, collaborative work culture. “The patient-centric fabric of Samsung Biologics enables the collective persistence necessary for overcoming the challenges of not only setting up a new laboratory environment, but also meeting the needs of clients with varying ADC project needs,” he says. Understanding of specific client needs enabled by skilled project management harmonize the ADC team and Samsung Biologics at large. Details of each project are orchestrated to combat any gaps in scheduling, which ensures timelines are met without exception. This patient-centric mindset throughout the company translates to securing promising partnerships. Joseph Jeong, Vice President and Head of ADC Development, knows that a strong CDMO partner understands the client’s specific technical needs from the bottom up. “By catching onto a detail that a prospective client mentions in passing mid-discussion, we demonstrate that we can be trusted to deliver on complex projects,” he says.Conversations like these drive Jeong and his team to embrace the durable mindset of a craftsman, undeterred by whatever challenges may lie ahead. From enzyme-mediate conjugation and engineered antibody conjugation to glycan-bridge conjugation, the Samsung Biologics team is continuing t

monoclonal antibodies, mRNA vaccines, and advanced multi-specific modalities. One of the earliest applications of AI will be in predictive maintenance. It is critical to keep lyophilizers operational because of their costs and the essential role they play in production. AI-driven systems under development could monitor subtle changes, such as variations in chamber vibrations, to predict when preventive maintenance is needed. These proactive approaches go beyond current preventive maintenance practices, allowing for timely intervention before issues arise Comprehensive drug lyophilization services Several critical factors should be considered when selecting a CDMO partner for lyophilization to ensure the process meets rigorous quality and efficiency standard. In this whitepaper, we explore the importance of the following five attributes for quality lyophilization services:Process expertiseAutomation and quality controlCapacity and equipment scalabilityRegulatory compliance and quality standardsRedundancy and reliability

monoclonal antibodies. This ultimately leads to unwanted entrapment of proteins in the cell’s Golgi apparatus, preventing secretion of naturally folded proteins and causing premature degradation. Therefore, efforts to raise titer have proven to be counterproductive, as they simultaneously compromise purity of the API. As a means to directly address this challenge, the DSP team has established their working system for removing impurities from extracted proteins. Initial steps of the procedure are facilitated through in silico analyses of different physico-chemical properties, which help to efficiently select more favorable resins from an established library. To address host cell proteins (HCPs) – one example of process-related impurities – the DSP team works side-by-side with the Analytical team, utilizing their capabilities in liquid chromatography-mass spectrometry to track HCPs down to their specific types while screening for various types of chromatography resins.The CLD and process development (PD) teams as one collaborative entity have been consistent in their approach to on-time communication with clients. The teams make use of a comprehensive in-house analytical capability, with methods encompassing charge to size variants and customized to the molecule. They evaluate quality for samples during process development and for drug substance or product, various attributes and molecular stability being assessed through state-of-the-art analytical methods such as rigorous MS spectrometry, which confirms relationship with potency. “The client may feel more at ease about various glycan variants if it is confirmed that glycosylation does not interfere with the molecule’s potency, and this will have impact on establishing specifications,” said Yoonsik Kim, a senior scientist in Analytical Development. Such decisions can only be made with multiple batches available; with discretion informed by the client’s needs, Samsung Biologics is able to flexibly conduct diverse fusion protein projects especially when the client has extensive experience and requests. “Internal project management teams excel in handling these requests,” said Bongkyu Choi, Associate Director of Downstream Processing. “One client in particular took the time to let us know how satisfied they were with our performance.”“Alongside customized CLD, USP, DSP, and analytical development steps, the formulation phase for fusion proteins requires a detailed understanding of the molecules’ solution behavior,” explained lead scientist Derrick Katayama of Formulation Development. The DEVELOPICKTM platform, now enhanced to version 3.0, provides early investigation into the behavior of a client’s fusion protein including hydrophobicity, informing an appropriate formulation strategy. “DEVELOPICKTM gives us a clue into aggregation and solubility problems that may arise,” said Heonchang Lim, Director of Formulation Development. “This helps inform downstream colleagues and saves clients time.” Such early detection of formulation development risks translates to flexible execution of client requests. For example, when a molecule is especially poorly behaved, the client recommends that the team moves forward with lyophilization immediately. Close collaboration between the CLD, USP, DSP, analytical development, formulation development, and CMC (chemistry, manufacturing and control) support teams enable technological innovations and client communication to successfully complement each other at Samsung Biologics. Through its technological expertise and track record of success, the CDMO helps clients navigate through unforeseen hurdles that may arise from the drive toward ensuring quality in the overall development process. The Transposase system used in the beginning helps achieve high quality and titer by bypassing random integration, reducing the CLD timeline by an entire mo

Known for its industry-leading capacity, Samsung Biologics is also well equipped with advanced manufacturing technology and processes to execute projects for complex modalities including multispecific antibodies. The multispecifics market, driven by the development of new treatments, is forecast to have a compound annual growth rate of 9.5% during the 2024-2030 period [source]. And the number of multispecific antibody medicines in clinical development is predicted to grow from 900 currently to over 1,200 [GlobalData] [source]. While multispecifics can present challenges in manufacturing due to their elaborate molecular structure, Samsung Biologics offers strengths in agility, flexibility, operational excellence, technology innovation, and timely capacity expansions to support clients’ complex manufacturing needs. Committed to meeting clients’ manufacturing timelinesSamsung Biologics has an extensive track record in meeting production timelines. Two bioreactors for each train in the CDMO’s most recently constructed biomanufacturing plants – also to be the case for upcoming plants in BioCampus II – enable short production turnaround times and allow for agile project execution.Powered by such agility, a recent multispecific antibody manufacturing project at Samsung Biologics received successful process performance qualification (PPQ). “Starting from due diligence prior to the kick-off meeting, we set up processes based on a facility fit assessment and mass balance analysis,” said Joomyung Lee, Lead Engineer and Director of the Purification Group in one plant. “Through organic collaboration between the client and our manufacturing science and technology (MSAT), manufacturing, and corporate engineering teams to address any gaps in the process, we successfully kept to the timeline for introducing all necessary equipment for the project.” Jeongsoo Lee, Senior Scientist in the plant’s Tech Transfer Group, said: “We had to separate parental materials of the multispecific product even though they underwent the same processes when being manufactured. We did this by running the processes on separate trains, achieving successful segregation and cadence.” Optimized timelines for validation and vendor management also pave the way for agile execution of projects. “Thanks to the close collaborative relationship formed with our vendors during plant capacity expansion by our purchasing and procurement department, we were able to successfully complete the introduction and authorization of new equipment on time,” Joomyung said. His group completed the design, procurement, and validation of the ultrafiltration / diafiltration (UF/DF) skid in a shorter time than the conventional lead time suggested by the vendor. Flexible processes and facility fitAlso of note has been the CDMO’s flexibility. Designed to fit processes for diverse complex molecules, Samsung Biologics’ facilities minimize delays caused by product change-over and suboptimal production cadence.“To accommodate diverse complex molecules and processes, we have additional main equipment, utility, and supporting equipment necessary to proceed with setups apart from those used for conventional antibody processes,” said Joomyung. “There were many unit processes and required equipment compared to regular processes, but we had the flexibility to carry this out. On top of the engineering and construction capabilities for independent modification of our plants, we had the flexibility and automation needed for introducing new sensors.” Commitment to operational excellence and technology innovationsEqual in importance as Samsung Biologics’ flexibility is its commitment to upholding high standards in operations. Validation and maintenance can introduce hurdles at any step, but the CDMO’s risk-based and phase-appropriate approaches help root out inefficiencies. The mul

monoclonal antibodies, reducing the harmful side effects typically associated with chemotherapy. The toxic nature of the drugs requires strict safety protocols for the safety of scientists and staff involved, as well as the quality of the product. While ADCs represent a promising next-generation treatment, developing and manufacturing ADCs are highly complex and requires extensive expertise, advanced technologies, and improved analytical methods. Ensuring the stability and efficacy of ADCs through precise attachment of the linker and payload is key to therapeutic success, while efficient production and cost-effective scaling are also crucial for commercial viability.As the ADC market grows, more developers are expected to rely on contract development and manufacturing organizations (CDMOs) to advance their projects. Selecting a CDMO with expertise in linker and payload technologies, along with facilities for cytotoxic drug product manufacturing, is essential to propel a program forward. With a stellar track record of success as a trusted CDMO partner, Samsung Biologics is able leverage its extensive expertise in antibody manufacturing, antibody engineering, and large-scale production, as well as cutting-edge facilities to play a pivotal role in ADC production.Integrated expertise and cutting-edge technologySamsung Biologics’ commitment to advancing ADC development is demonstrated through ongoing investments in its development and manufacturing capabilities. The company’s new ADC facility is designed to support the entire spectrum of ADC production, from pre-clinical to commercial manufacturing. Equipped with state-of-the-art facilities and cutting-edge technologies, Samsung Biologics is uniquely positioned to meet the intricate demands of ADC manufacturing at a single site. Manufacturing highly toxic biomedicines at a single location reduces containment risks by centralizing specialized facilities and expertise. It also minimizes transportation time and distance, streamlines the supply chain, and fosters focused research and development, leading to consistent product quality and innovation. This integrated approach ensures Samsung Biologics’ ability to offer a seamless, comprehensive ADC development program, effectively addressing key challenges. “The complex requirements for ADCs often rely on a fragmented supply chain; therefore, it can be challenging to ensure consistent quality controls, synchronized timelines, and efficient communication across various vendors. By using a single CDMO partner, clients can simplify supply chain logistics and adopt a robust approach to eliminate bottlenecks, resulting in reliable and consistent production.” said Yoonjin Kwon, Lead Scientist in Analytical Development and a member of the company's ADC Task Force. 4F Future Space3F Laboratories2F Conjugation1F Utility & LogisticsThe facility features a flexible design accommodating both single-use and stainless steel options, capable of scaling production up to 500 liters to meet diverse client needs. It is equipped to handle Highly Potent Active Pharmaceutical Ingredients (HPAPIs), antibodies, and complex linkers with precision. Advanced isolator technology ensures stringent exposure management, safeguarding both product integrity and personnel safety, while meeting stringent occupational exposure limit (OEL) requirements for GMP production of clinical and small-scale ADC batches.“We manage components (payload, linker and antibody) of the ADC through consistent quality and rigorous analytical development—every step of the way is validated and tested to ensure patient safety. That is always our top priority,” Kwon added. Samsung Biologics’ commitment to innovation extends beyond its facilities and technologies. Through strategic investments through the Samsung Life Science Fund, the company is supporting Araris Biotech AG for their linker-payload toolbox and conjugation technology, as well as AimedBio for their ADC pipelines. Samsung Biologi

monoclonal antibodies to Fc-fusion proteins, has yielded a higher titer under a condensed timeline when compared to results from other industry platforms. Quality comparisons, based on percent purity analysis, demonstrate compatibility, enabling a wide range of options for our clients' development needs. “We wanted to add S-CHOsient™ to our development platform portfolio to help build a reliable foundation for successful drug development for our clients,” said Lee, Director of Cell Line Development at Samsung Biologics. “By assessing a thorough molecule characterization and expressing robust genes, the platform prepares our clients to unleash the full potential of their molecules.”Navigating the intricate pathway to biopharmaceutical commercialization also demands careful selection of the right sequence or molecule for development. Samsung addresses this challenge through DEVELOPICK™, a tool that assesses the physical-chemical properties of molecules, providing crucial insights into purification processes and setting the stage for efficient cell line development (CLD). Developing strong cell lines through an enhanced CLD platform Samsung Biologics’ CLD platform is rigorously designed to generate robust cell lines. S-CHOice®, a high-performing proprietary cell line platform built on glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line technology, shows improved titers up to two-fold from industry average, reaching above 7g/L for standard monoclonal antibodies. The cell line also shows enhanced cell viability with over 90% at day-21 in a fed-batch study, demonstrating effectiveness in producing high-quality cell lines. With both standard and transposase processes, the platform has successfully developed over 60% of monoclonal and 20% of bispecific antibodies.The recent introduction of a transposase gene integration system further enhances titers. With the capability for multiple insertions across the genome and applicability to genes of all sizes, while maintaining structural integrity, the transposase system has resulted in notable increases in productivity, purity, and stability. S-CHOice® generated a 3 to 7-fold increase in cell-line productivity and a significant 33% reduction in the standard timeline for monoclonal antibodies, leading to a two-month period from transfection to Research Cell Bank (RCB)* selection. Additionally, bispecific antibodies experienced a 25% reduction, allowing for a three-month period from transfection to RCB selection.Fostering End-to-End Collaboration for Challenging CaseSeamless communication and collaboration across teams at a single site is another key advantage of partnering with Samsung Biologics. In a recent partnership, Samsung Biologics addressed a client's low-expressing CHO cell line (IgG4) challenge through its S-CHOice® CLD platform, achieving a notable 2.4-fold increase in ex-pression. However, during quality analysis slight deviations were revealed in critical quality attributes (CQA), including the charge variants. The analytical team promptly responded, strategically leveraging process parameters and component lists to address the quality aspects. This collaborative effort extended to the upstream and downstream teams, that identified critical quality attributes and had a feasibility run, allowing the team to optimize processes for purity, yields, and comparability at the drug substance phase. The successful screening early in the project, guided by the right analytical methods, resulted in a remarkable 3.4-fold overall increase in productivity. This case study underscores the effectiveness of end-to-end collaboration, showcasing the ability to overcome challenges, achieve higher productivity, and meet client expectations.Continuous platform enhancement driven by client-centric mindsetClient satisfaction is our No. 1 priority in our business operations

monoclonal antibodies continue to lead the biologics market, innovation has increased demand for other modalities, such as bispecific antibodies, fusion proteins, and antibody-drug conjugates. Successful drug development relies on a thorough understanding of a molecule’s characteristics. Each development journey is unique and complex, while each client’s needs are diverse—meaning flexible and customized approaches are essential to pave the way to the clinic. Building on its proven track record of success as a contract manufacturing and development provider, Samsung Biologics has optimized development services incorporating innovative processes and advanced platforms** to accommodate clients’ evolving needs - supporting their journey from gene to investigational new drug (IND) and/or beyond.**S-CHOICE® is a high-performing CHO-K1-based cell line development that improves titers.**S-DUAL™ is an advanced high-yield bispecific antibody platform that enables high binding affinity to produce higher titer and purity.**DEVELOPICK™ provides selection guidance to predict candidates with the best developability to minimize time and cost and maximize efficiency. To proactively satisfy and serve a client’s specific needs, Samsung Biologics has packaged its drug development services into three programs—each designed to ensure maximum flexibility and meet the client’s goals per their development stage. Utilizing pre-built modules, Samsung Biologics implements a highly streamlined approach, while assessing potential risks that may occur along the way. This framework gives clients a guideline of where to start and what to expect—speeding up the process and mapping out the strategies. Simplified IND PackageThe simplified IND package focuses on IND Phase I, utilizing Samsung Biologics’ proprietary platforms. The key priority is accelerating the timeline, while ensuring appropriate quality and effectiveness requirements. The company has designed the program to meet a timeline of 11 months for monoclonal antibodies and within 13 months for complex molecules. Comprehensive IND PackageThe comprehensive IND package provides a multi-faceted scope to clients who wish to mitigate risks and opt for a more stable development process. The service consists of robust data items, including CMC data and stability studies, while quality attributes beyond IND Phase I are assessed in advance to measure potential risks that may occur in the late phase. This program aims to support clients who want to take their pipelines to commercialization by pursuing a more detailed and comprehensive service with add-on options for complex mechanisms. Enhanced CMC PackageThe enhanced CMC package focuses on improving productivity. This program facilitates end-to-end provision through the replacement of cell lines, processes, or formulation to meet the client’s need for improvement and ensure a seamless journey to commercialization. Through this package, clients can leverage Samsung Biologics’ experience and expertise based on proven track records to enhance their manufacturability in need of improvement, while maintaining other quality attributes necessary to move on to the next development phase. Each program—designed based on years of experience and expertise—comes with basic, indispensable requirements. Clients can also add a range of comprehensive service options to fine-tune their own best-fit package, depending on their development needs and molecule type. A trusted CDMO partner to accelerate drug development success As drug developers prioritize a first-to-market approach, a growing number of clients want to leverage a CDMO’s platform for faster development and their regulatory expertise to overcome unexpected challenges. Samsung Biologics’ CDO services aim to achieve successful IND submission and minimize the chances of redevelopment. The company can also support a smooth and scalable manufacturing process with its world-c

monoclonal antibodies that only target one type of antigen. Many complex diseases are driven by a variety of factors, which can circumvent the impact of a drug. Bispecific antibodies can improve the specificity and effectiveness, such as in the case of cancer immunotherapy. One arm binds to an antigen on a cancer cell, while the other binds to T-cells, bringing both cell types together to activate T-cells to eliminate the cancer cells.However, there have been challenges in development of bispecific antibodies, especially regarding immunogenicity and chain mispairing, while issues in respect to the quality and stability have hampered their wider clinical application.S-DUALTM boasts safety and optimal manufacturabilitySamsung Biologics launched a new proprietary development technology platform, S-DUAL™ in September, boosting its strength in the CDO service. Having a unique asymmetric design, S-DUAL™ has high purity, yield and productivity. In the production of bispecific antibodies, only one of eight possible combinations is bispecific – requiring advanced technology to differentiate it. With a unique asymmetric design, S-DUAL™ can effectively separate and analyze the bispecific antibody as impurities from the improper pairings form different sizes.It also applies ‘knob-in-hole’ technique to avoid mispairing between two heavy chains and light chains. This strategy provides high yield and maximum purity of 99%. S-DUAL™ also has low immunogenicity due to human immunoglobulin gamma (lgG)-like structure. Samsung Biologics can design tailored antibody structures depending on clients’ needs. Biopharma’s new drug development partnerAs Samsung Biologics provides end-to-end services, from contract development to contract manufacturing, it has a competitive edge in new drug development, where speed is crucial. Samsung Biologics has received over 160 regulatory approvals as of October 2022. The company has also strengthened its foothold as a new drug development partner by establishing a one-stop service from cell line development to commercial manufacturing, and opened an CDO R&D Center in San Francisco to provide services in close proximity to clients.To meet fast-changing industry trends, Samsung also launched DEVELOPICK™, a developability assessment platform that screens molecules at an early stage to identify candidates with the best potential for advancement to Investigational New Drug, alongside the S-DUAL™. Samsung Biologics will continue to invest and take action to lead in the next-generation of biopharmaceuticals. Related ContentWhitepapers Fundamental Considerations for Bispecific Antibody-based Cell Line DevelopmentSamsung BIO Insight BioProcess International 2022 | Samsung Biologics unveils new development platforms to offer differentiated services

monoclonal antibodies (mAbs), are continuing to see strong market demand, but despite the robust pipeline for mAb development, there are bottlenecks that still exist. In this article, Seokjin Chang, our Director of Market Intelligence, identifies where the bottlenecks occur and how the investments CDMOs bring to the process can allow biopharma and biotech companies to avoid them. Read more (Page.16)

monoclonal antibodies)Marked record-high financial results(Accumulative revenue of KRW 1.24 trillion and operating profit of KRW 408.5 billion as of third quarter of 2021)Expanded mRNA services offerings(Signing mRNA DP contract, adding mRNA DS manufacturing suite, and securing additional land for the building of MMP)Launched ESG management system(lssuing first annual sustainability report, joining DOW jonse Sustainability World index(DJSI), participating in Sustainable Markets Initiative Task Force)*Multi-Modal Plant *Korea Corporate Governance Service*Dow Jones Sustainability ‘World’ Index*Sustainable Market Initiative Business goals and vision for 2022 1) Expanded manufacturing capacityExpanded manufacturing capacityPlant 1(30,000L)Plant 2(154,000L)Plant 3(180,000L)Plant 4(256,000L) ● Plant 4 partially operational (Q4 2022) ● Secure additional sites within Songdo for Bio Campus II 2) Advancements in business portfolioAdvancements in business portfoliomAb/Fusion ProteinCell/Gene Therapy Vaccine, Viral VectormRNAmAb/Fusion Protein+Open Innovation ● Successfully process mRNA DS CGMP Ready (Q2 2022)● Groundbreaking of Plant 5, which will offer multi-modal products including cell & gene therapies and next-gen vaccines utilizing mRNA, pDNA and viral vectors, all at a single site ● Establish plans for Open Innovation Center 3) Greater global footprint ● Expand overseas, additionally to San Francisco R&D Center Related contentsNews Brief JP Morgan Healthcare Conference (Audio Link)YouTube The Future of BioPharma: Plant 4

monoclonal antibodies to IND and BLA. Along with its proprietary cell line development platform S-CHOiceTM, the company’s CDO business continues to bring quality-driven, end-to-end development services to accelerate the speed of molecules to market. Furthering its sustainability efforts, Samsung Biologics joined the global Frontier -1.5D initiative to develop a climate risk management model as part of the 2050 Carbon Neutral Strategy in response to the ongoing challenges associated with global climate change. Through its Carbon Disclosure Project, the company will determine the risks and opportunities within its business to address climate change, and then analyze the financial impact to adjust its response policies in relation to factors such as the reduction of GHG emissions. Despite the lingering effects of the COVID-19 pandemic on global markets, Samsung Biologics has maintained stable business operations and the construction of plant 4 remains on track and active discussions are taking place with clients regarding future projects. It is expected to be partially operational by the end of 2022 and fully GMP-ready in 2023 in an effort to meet increased production demand. For more details on performance and financials, please refer to the Earnings Release.

Monoclonal Antibodies for the treatment of HIV and SARS-CoV-2. In addition, there will be continuing discussions for other Monoclonal Antibodies being developed by Enzolytics. The Enzolytics protocol offers the opportunity to implement A.I. analysis and provides a platform for creating multiple fully human Monoclonal Antibodies targeting conserved immutable sites on the virus and offering a cure for these viruses. A stable cell line will be manufactured with support from Samsung Biologics' R&D Center in San Francisco. Its related clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea. “Partnering with Enzolytics reinforces the value of our fully integrated, end-to-end business model, which is designed to meet the unique needs and goals of our biotech clients,” said John Rim, CEO of Samsung Biologics. “We look forward to providing comprehensive services and professional support for the manufacturing of this important class of Monoclonal Antibody therapeutics for the treatment of HIV and SARS-CoV-2, helping to accelerate the process of drug development to IND filing and bring these life-saving products to patients.” "The collaboration with Samsung Biologics is a significant milestone for Enzolytics' Artificial Intelligence enabled Monoclonal Antibody Platform. We chose to partner with Samsung Biologics because of Samsung Biologics' extensive experience and expertise in developing, producing, and manufacturing Monoclonal Antibodies for Infectious Diseases and Oncology.” said Dr. Gaurav Chandra, Chief Operating Officer Research and Development at Enzolytics. “This partnership marks a pivotal milestone for Enzolytics to significantly advance the clinical development of our universal, durable, broadly neutralizing Monoclonal Antibodies and reduce time to the clinic and offer the much-needed treatment for patients."

Biologics are complex, large-molecule substances* that require controlled processes and up-to-date technology to develop. An excellent understanding of the scientific, logistical, and regulatory challenges is also essential for the successful development of biologics to reach product approvals before going into large-scale manufacturing. With considerable challenges to safely and effectively develop biologics, many biopharmaceutical companies are choosing to outsource their development processes to CDO partners. In response to the increasing demand of biologics, Samsung Biologics now not only holds the world’s largest biomanufacturing capacity, but also offers contract development services, establishing the company as a one-stop CDMO service provider. In October 2020, Samsung Biologics opened its first R&D Center in San Francisco, at the heart of the leading U.S. bio-cluster, to be in close proximity to clients as the next door CDO partner. In this article, we will explore the services a CDO partner provides and the unique capabilities Samsung Biologics can bring for a molecule’s success.*Refer to “A New Era in Biotechnology: What are Biomedicines?” Contract Development Services to Expedite Success for Your MoleculeThe development of new drugs is divided into two different stages: the ‘discovery’ stage where a candidate molecule for a specific disease is discovered and the ‘development’ stage which includes all the processes that are required to reach clinical trials and gain product approvals. Contract Development Organizations (CDO) provide the ‘development’ part of the service required for the overall development of new drugs. *Preclinical Trials: Research using animals to find out if a drug, procedure, or treatment is likely to be useful**Clinical Trials: Research studies performed in people to test the stability and safety of a new candidate molecule Drug development is a costly process that takes on average more than a decade from discovery to approval. Both the costs and timelines still continue to rise with the increased identification of novel targets and their associated modalities. Due to the huge investment that goes into the development of a single drug, biopharmaceutical companies have the potential to become market dominant upon their application for patents of the product. Hence the order of market entry is a critical factor to market share with the first and second products commercialized accounting for over 70%. As such, a faster timeline to develop a new drug is important now more than ever. Major biopharmaceutical companies are opting to outsource the development processes to CDO partners to expedite the timeline to market and enhance efficiency. By outsourcing to a CDO partner like Samsung Biologics, biopharmaceutical companies, no matter the size, are able to gain access to top-notch R&D capabilities, up-to-date technology, and teams of experts to ensure both the quality and speed of their molecules. The Journey to a Successful Development of BiologicsOnce a client discovers an initial candidate molecule and a contract development agreement is made, cell line development begins. A cell line is a permanently established cell culture that will proliferate indefinitely given the appropriate fresh medium and space to ultimately produce antibodies for biomedicines. Upon completion of development for a high-quality cell line, a CDO partner begins the development of ‘process, formulation, and analysis’ which is followed up by ‘non-GMP Drug substance and Drug Product’ manufacturing that are needed for preclinical trials. Once the manufacturing and stability testing are completed, submission for IND approval is done. Faster and Better CDO Services‘Technology’ and ‘speed’ are key competitive advantages that Samsung Biologics offers. In August 2020, Samsung Biologics introduced its own proprietary cell line, S-CHOice, offering a wide array of choices for its clients. S-CHOice builds on glutamine synth

monoclonal antibodies (mAb). “We are constantly assessing various ways that we can expand and persify our current business portfolio to better serve the market,” said John Rim, CEO of Samsung Biologics. “We are committed to helping our clients provide quality treatments and vaccines to all those in need around the world, especially in difficult times like this, and with this extended capability, we hope to support our partners in bringing novel mRNA vaccines and therapeutics to market at a faster pace.” In an effort to extend its global expansion and build a perse portfolio, Samsung Biologics has also opened its newest US R&D Center in the heart of the San Francisco biocluster, bringing its contract development services closer to biotech and pharmaceutical companies in the Bay Area. With its own proprietary cell line technology, S-CHOice, which shows enhanced cell viability and improved titers up to two-fold from the industry average, Samsung Biologics can facilitate reduced development timelines and high-performing product offerings. The company’s dynamic growth plan also includes the ongoing construction of its fourth and largest biomanufacturing facility in Incheon, South Korea. Upon completion of Plant 4, Samsung Biologics will hold a total of 620,000 liters of cell culture capacity and continue to provide end-to-end, start-to-finish services to its clients.

monoclonal antibodies has proven to be an important therapeutic approach for the management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth or function of B-cells.

monoclonal antibodies and by targeting diverse treatment areas including cancer, neurodegenerative diseases, and as with this partnership, COVID-19 treatment. Samsung Biologics has also recently introduced its proprietary cell-line technology, S-CHOice, this year showing improved titers up to two-fold from the industry average and maintaining over 90% cell viability. With a customized development strategy, Samsung Biologics has showcased a record of achievements in recent years. The company has dramatically reduced the time required for the development stage, taking six months to clinical material manufacturing and seven months to DP release. “Samsung Biologics is always committed to providing the highest quality services to our clients globally to help biotech companies like Dinona focus on their core business, which is drug discovery,” said Tae Han Kim, CEO Samsung Biologics. “As with all our partnerships, we will closely collaborate with our client Dinona to provide the highest client satisfaction and support in its endeavor to bring a potential COVID-19 treatment to market faster and better.”

monoclonal antibodies. The cell line also shows enhanced cell viability with over 90% at day-21 in a fed-batch study, demonstrating effectiveness in producing high quality cell lines. Moreover, S-CHOice has a speedy cell division of 18-20 hours and together with Berkeley Lights Beacon® technology, Samsung Biologics can offer reduced development timeline by a month from the industry average of four to five months. The company will also provide attractive payment terms for clients choosing to use this cell line technology for their future development. Leveraging these combination of advantages, Samsung Biologics recently signed a development contract with a client under which S-CHOice will be used to advance its cell line development. “We are extremely proud to announce the official launch of our own proprietary cell line, S-CHOice,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “With this advanced, high performance technology, we can now offer our CDO clients with even more promising options in bringing their molecule faster and better to the market and ensure world-class client satisfaction during this continuously evolving global climate.”