In an unpredictable drug development environment, small to mid-sized biotechs may want to work with external partners to increase the chance of bringing success to their drug development projects.

In this article, Jahoon Kang, Vice-President and Head of CDO Development Department, and Yeukyung Yoon, Associate Director in Analytical CMC Development, at Samsung Biologics probe the role of contract development and manufacturing organisations (CDMOs) in providing versatile process development platforms and customised solutions designed to create an optimised set-up for drug manufacturing. They provide unique insights and emphasise how early-stage integration of innovative solutions can execute rigorous drug-development projects without delaying timelines or impacting quality.

The need for robust, tailored drug-development strategies

Conventionally, drug developers are under constant pressure to deliver safe, effective therapeutics for patients at an opportune time. In the post-Covid-19 pandemic environment, it has become the norm to achieve key milestones in a faster and more efficient manner.

In response to changing business dynamics, there is a growing need in drug development and manufacturing for robust, tailored strategies that allow small biotech companies to progress and scale their therapeutics without unexpected delays or errors.

These strategies must minimise risks and provide the right solutions that arise from new business priorities or demands.

Overcoming the challenges of antibody biologic development

 

 

 

 

 

 

 

For drug developers looking to outsource their novel antibody molecules, partnering as early as possible with a CDMO that understands the implications, such as target gene sequences when plodding through process pathways, is the key to success. Below are several key elements a competitive CDMO must adopt:

1. An integrated development strategy

The unique characteristics of antibody biologics can cause development and manufacturing issues and resultant delays that could leave patients without much-needed therapeutics. An integrated development strategy ensures a holistic understanding of how decisions at an early stage impact all subsequent stages. It requires all teams to work together – enabling the free flow of information – and an understanding of how changes in processes could impact the critical quality attributes (CQAs) or cost of goods throughout production.

2. Expertise and understanding in ascertaining risk

Technical capabilities and competencies are paramount for success in antibody biologic development. Navigating the unique characteristics of antibodies demands a profound grasp of potential production pitfalls and a detailed understanding of the molecules.

The understanding needed to build a successful development strategy and overcome critical manufacturing risks comes from experience, a wealth of expertise, and proactive discussions between drug developers and their CDMO partners. If it is necessary to re-engineer processes, it is vital for a CDMO to use the in-depth knowledge gained from the developers and to understand their goals to identify and apply the appropriate solutions.

3. Customised CMC solutions built on flexibility and applicability

Innovative technologies are key to developing biologics from concept to the final product. CDMOs aid the development process by deploying proprietary chemistry, manufacturing and control (CMC) services tailored to addressing common issues stemming from dealing with intricate biologics at all stages of development. CDMOs combine expertise with effective CMC approaches – designed to address each specific need of drug developers in need of a customised expertise to bring their uniquely constructed molecules to development success and ultimately to commercialisation – to resolve these issues:

1. Simplified investigational new drug (IND): Streamlining cell line development sets up the optimised environment for reliable biomanufacturing while leveraging advanced techniques, such as high-throughput screening and data analytics, to increase the commerciality of the product. Generating high-yield cell lines by using compact, but advanced technologies – such as transposing and analytical methods – may pre-empt issues that could appear in subsequent development stages, including, but not limited to, the low efficacy and safety of therapeutics.
2. Comprehensive IND: Advancing molecules with distinctive characteristics to the IND stage requires multi-faceted, data-driven analyses, which is a bedrock for developing and eventually commercialising quality therapeutics. Drug developers hoping to bring their uniquely-designed molecules all the way from early development to commercial production, with risks mitigated to the most extent, may consider partnering with CDMOs capable of first nurturing then manufacturing their molecules.

iii. Enhanced CMC: Finding alternative approaches to enhance already developed molecules, such as increasing productivity, may be a required route for drug developers unsatisfied with their existing product’s manufacturability. In such circumstances, developers may consider working with CDMOs prepared to offer a scrupulously-designed redevelopment approach intended to reinforce the manufacturability of their molecules.

These solution-oriented services infuse innovation and efficiency into each development phase to minimise potential delays on the pathway to IND application or biological license application.

Navigating the future of antibody biologics

Antibody-based therapeutics are the core of biologics with the evolution of antibody engineering technology. The ability to mitigate the inherent development risks and improve the productivity of these products will play a pivotal role in CMC development. Delivering these innovative medicines to patients who urgently need them requires an integrated development and manufacturing strategy and customised solutions supported by a trustworthy partner. By partnering with a competitive CDMO, an innovator can have a fully-integrated product road map – from discovery to commercial launch – sooner.

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1. Liu JK. The history of monoclonal antibody development – Progress, remaining challenges and future innovations. Ann Med Surg (Lond). 2014 Sep 11;3(4):113-6.
2. Lyu X, Zhao Q, Hui J, Wang T, Lin M, Wang K, Zhang J, Shentu J, Dalby PA, Zhang H, Liu B. The global landscape of approved antibody therapies. Antib Ther. 2022 Sep 6;5(4):233-257.

Samsung Biologics

Samsung Biologics is a fully-integrated, end-to-end CDMO service provider, offering seamless development and manufacturing solutions from cell line development to final aseptic fill/finish, as well as laboratory testing support for the biopharmaceutical products manufactured by Samsung Biologics. All development/manufacturing facilities at Samsung Biologics are cGMP-compliant with bioreactors ranging from small to large scales to serve varying client needs.

To maximise operational efficiency and expand capabilities in response to growing biomanufacturing demands, Samsung Biologics launched Plant 4, which further advances the company’s standing as the world’s largest manufacturing facility at a single site – holding a 604KL total capacity – and is currently constructing Plant 5, which will be operational in 2025.

Additionally, Samsung Biologics has established a presence in San Francisco, Boston and New Jersey to conveniently cater to its partners based in the US and Europe. The company continues to upgrade its capabilities to accommodate clients by investing in technologies such as an antibody drug conjugate (ADC) facility, a dedicated mRNA manufacturing facility and additional aseptic filling capacity. As a sustainable CDMO partner of choice, Samsung Biologics is committed to on-time, in-full delivery of the products manufactured with flexible manufacturing solutions, operational excellence and proven expertise.

Biographies

Jahoon Kang, Vice-President and Head of CDO Development Department at Samsung Biologics, has over 25 years of experience in clinical research and development in the biopharmaceutical and pharmaceutical industries. Kang began her career at Chong Kun Dang in 1999 as a Clinical Research Associate, then transitioned to Novartis, overseeing clinical operations in Korea and also clinical projects at the company’s headquarters in Switzerland. She expanded her career at Hanmi Science in 2015 as Vice-President for the Clinical Research and Development Division and co-founded Lumebio in 2019.

Yeukyung Yoon is an Associate Director in Analytical CMC Development at Samsung Biologics, where she manages the method development and analysis of drug development projects. With over a decade of experience in the biopharmaceutical industry, Yoon has worked on method development for quantitation of impurities and confirmation of biological activity and led numerous development projects to approvals by regulatory agencies, such as the US Food and Drug Administration. She holds a master’s degree in life sciences (Lab of Molecular Neuroethology) from Gwangju Institute of Science and Technology (GIST) and a bachelor’s degree in genetic engineering from Kyunghee University.