EXECUTIVE INTERVIEW - Samsung Biologics: Exploring The Evolving Biopharma Landscape

Biologic development and manufacturing is a rapidly growing sector requiring ample investment and attention to meet rising demands. Advancements in technology, growing understanding, and strategic approaches have shifted the biopharmaceutical industry to better position itself to meet growing demands with innovative thinking.

Drug Development & Delivery recently interviewed Kevin Sharp, Senior Vice President and Head of Sales for Samsung Biologics, to discuss the evolving biopharma space, exploring current challenges, and the demand for sustainable solutions.

Q: The biologics market is rapidly evolving, what are some of the current trends shaping the biologic landscape?

A: The biggest shift in biologics is the modalities currently in development. As antibody-based therapies have risen to be the most important therapies in the biologics space, our understanding of biologics, how to manipulate and tailor their production through strategies such as cell line development, and the impact they have on the body have been extensively studied, paving the way for new drug products.

Innovative thinking has already led to the design of powerful advanced therapeutics, such as bispecific antibodies (BsAbs), fusion proteins, and antibody-drug conjugates (ADCs). We are seeing a drive toward developing these novel materials, which often provide enhanced performance, with improved efficacy and binding specificity compared with monoclonal antibody counterparts. As a result, BsAbs and ADCs can offer improved safety and lower dosage requirements.

BsAbs are engineered to bind two different epitopes or antigens, improving specificity by simultaneously binding two targets. BsAbs have shown promise for treating severe cancers, such as multiple myeloma, non-small cell lung cancer, and cervical cancer, and the number of novel DPs like BsAbs entering clinical trials is expected to increase further. In addition to BsAbs, ADCs, which are formed when an antibody is attached to a cytotoxic payload, are commonly used as cancer treatments.

Utilizing these complex biologic products for treating complicated diseases, such as chronic and rare disorders, is on the rise. As a result, we will see more of these novel treatments entering the drug market. However, the complexity of these materials means the processes used in their production are complex, necessitating experience and expertise to overcome any issues that may arise and successfully produce biologic therapeutics.

Q: How are technological advancements shaping biologic manufacture, and how can CDMOs offer support to help overcome potential challenges?

A: Digital technologies are advancing quickly, and industries must be quick to keep up with it or risk falling behind. This is no different when it comes to the development and manufacture of biologic drug products. The advancements in manufacturing efficiency and productivity as a result of technological advances can lead to a significant competitive market advantage. In a highly regulated industry, these technological advancements also provide regulatory compliance benefits, helping to ensure product quality through cutting-edge sensors and efficient data management.

Using data management systems such as cloud-computing platforms can ensure accurate, complete, and reliable data throughout drug product manufacture and life cycle, allowing for informed decision-making at every stage and easing collaborative efforts. Although helping to streamline development and manufacturing, the data hosted on digitized systems is at risk of cyber attacks. Effective cybersecurity must be in place to safeguard all sensitive data from cyber threats, in line with regulations. Encryption, multi-factor authentication, access controls, and continuous monitoring can all be leveraged for data protection. Deciding upon a trusted cloud-computing provider reduces the burden, and with built-in security, data safety is assured.

Contract development and manufacturing organizations (CDMOs) that have many of these data management systems already in place can support biotechs in optimizing data management and information flow during their outsourced projects. This can help significantly streamline overall development, saving time and cost.

Q: Why do you believe the biologic industry is currently experiencing capacity shortages, and what steps can be taken to overcome them?

A: There are many factors currently contributing to capacity issues in biologic manufacturing; the primary reason being shifts in demand for drug products. Expansion of a commercialized drug products, repurposing pre-approved drugs for alternative treatment uses, or the approval of a new drug to market can all lead to significant changes in demand.

Meeting the growing demand for biologics isn’t as simple as providing more space for manufacturing. Producing a biologic can be complex and requires dedicated capacity featuring specialized equipment and facilities, including the use of sterile processing lines for parenteral therapeutics. The industry is adapting to try and address this capacity shortage by:

• Harnessing technological advancements like automation and cloud computing to increase productivity.
• Utilizing innovative technologies like single-use systems or continuous manufacturing to enhance scalability and efficiency.
• Prioritizing efficiency to increase drug product output without significant changes to bioprocessing infrastructure.
• Designing manufacturing sites with consideration for the future, such as flexible and modular solutions for easy scaling and reconfiguration to continuously adapt to the market demands, seamlessly expanding as demand increases.

Introducing these changes in-house or partnering with a CDMO that has both capability and flexibility can help to meet evolving demands in capacity.

Q: Why is it important to carefully consider the location of a CDMO facility?

A: Partnerships and outsourcing are integral to biologics production. Being strategically placed geographically for these partnerships can help increase supply chain efficiency and ease collaborative efforts. Biopharma hubs have well-established supply chain networks, helping participants to navigate the procurement of essential materials and equipment cost-effectively, and with ease, for the efficient manufacture of drug products. Established transport links allow for efficient movement of raw materials, intermediates, and final drug products to and from a site, easing transfer logistics.

Q: Why is there such a demand for speed in the industry at the moment, and what changes are being made to meet these demands?

A: To deliver life-altering treatments to patients faster, there is a need for developers to deliver essential therapeutics to market at speed. Demand for shortened timelines to market is also driven by investors who require demonstrations of a return on investment (ROI).

An integrated development strategy provides a holistic understanding of the developability of a complex biologic. Implementing the right development strategy will allow the drug products most likely to reach Investigational New Drug (IND) filing and Biological License Application (BLA) to be quickly identified. The following features must be included in a successful development strategy to enable streamlined drug production:

• Taking into account the impact early decisions will have on stages further down the processing line.
• Relying heavily on free-flowing information for all aspects of development – from data on drug candidate performance to information on operations – among all teams and sites involved in the project.
• Understanding the developability risks of complex projects to identify potential risks early, allowing for rapid implementation of solutions.
• Using a developability platform, to score candidates based on their developability criteria and provide quantitative data to highlight the candidates with the highest likelihood of progressing through development and manufacture successfully.
• With a comprehensive understanding of the molecule early in development, biologics developers can mitigate risk and gather essential information needed to initiate processes further down the development and manufacturing pipeline.

Q: Why is sustainability such an important goal in the industry, and what are the biggest challenges preventing companies from reaching their sustainability targets?

A: Following the Paris Agreement in 2015, businesses throughout the healthcare industry have made commitments to limiting global warming to 1.5°C above pre-industrial levels. Sustainability is a focus across the globe, and to reach the Paris Agreement target, the biopharma industry must look at its operations and establish goals to minimize its greenhouse gas (GHG) emissions.

There are many hurdles hindering progress toward sustainable solutions. The biopharma industry is highly regulated, and any changes to a manufacturing process to reduce emissions will result in process re-validation.

The supply chain is the largest contributor to carbon emissions in the industry, accounting for more than 50%. The complexity of a supply network makes it hard to successfully navigate and decarbonize, with every part of the supply chain contributing to a company’s overall carbon emissions. Reaching sustainability goals relies heavily on communicative collaboration between supply partners, aiming to introduce sustainable systems, such as renewable energy and clean transport, across the entire supply chain.

Making use of the resources available can help guide companies to reach their sustainability goals. The Sustainable Markets Initiative (SMI) task force has outlined a number of actions that healthcare stakeholders can enforce as part of their decarbonization initiatives. Establishing and disclosing these sustainability goals and progress year after year can provide confidence the industry is doing its part in the sustainability initiative.