Taking a right-the-first-time approach to development, manufacturing, and regulatory compliance is essential to mitigating risks, as well as achieving efficient and successful approval of novel biopharmaceuticals. For biopharma companies that outsource, collaborating with an experienced CDMO partner that consistently demonstrates excellent performance across these areas is essential. Samsung Biologics delivers flexible, expert regulatory support, accelerating the journey to market for both traditional and innovative biologics with unmatched efficiency.
Navigating New Frontiers in Biopharma Outsourcing
In the past two decades, the biopharmaceutical industry has seen a significant shift toward outsourcing, with over two-thirds of biologic drug companies now relying on third-party service providers for some aspect of their production capacity.1 The increasing complexity and diversity of biologic substances and the intricate processes required for their development are partly driving this trend. Small and emerging biotech firms, which make up a growing fraction of the biopharmaceutical drug pipeline, as well as large global biopharma companies, frequently turn to contract development and manufacturing organizations (CDMOs) for specialized expertise, capabilities, and capacity — from early-phase cell line development to commercialization.
The most successful CDMOs have built their reputations on consistent, high-quality services and the ability to meet or surpass expectations during audits.1 Given the high stakes of drug development and manufacturing, choosing the right outsourcing partner is crucial for minimizing any associated risks.
Today, the scope of outsourcing spans analytical and process development, manufacturing, packaging, and, crucially, regulatory support for Investigational New Drug (IND) applications as well as Biologics License Applications (BLA) submissions. Established regulatory expertise, robust support in strategic development, and communication with regulatory authorities are increasingly becoming key differentiators for the most accomplished CDMOs, aiding companies in advancing their biologic candidates through clinical trials to approval and market authorization.
The regulatory landscape for biopharmaceuticals, especially novel modalities, is both complex and continually evolving. The repercussions of inadequate regulatory support can be severe, potentially jeopardizing patient safety and product viability. Therefore, partnering with a CDMO experienced in supporting a wide range of biomolecules targeting various indications and adept at navigating diverse regulatory environments worldwide is critical. Such partnerships can significantly enhance the efficiency of regulatory processes and expedite candidate progression and approval, sometimes making the difference between success and failure of a candidate biopharmaceutical. Samsung Biologics serves as a trusted CDMO partner to both global pharma and biotechs. Demonstrating expertise through the completion of over 400 successful projects, the company maintains rigorous standards in high-quality manufacturing and regulatory compliance. We understand that time is of the essence in biopharma, and as such, our approach to regulatory affairs is designed to maximize cost and time efficiency to better support our clients’ strategic goals.
Our Record of Regulatory Excellence
Since its inception, Samsung Biologics has dedicated itself to delivering the highest quality services as effectively as possible, always striving to exceed regulatory expectations. We invest substantially in compliance, audit support, and nurturing strong relationships with regulatory authorities worldwide. At the beginning of each project, we proactively identify and address potential regulatory issues to prevent delays and accelerate the development timeline, aligning our strategy with client needs for efficiency and speed.
This proactive approach has enabled Samsung Biologics to amass an impressive record of regulatory successes over the past decade. Since 2015, we have achieved more than 30 IND clearances and received approvals surpassing 300 products in over 50 countries within less than a decade. Our track record speaks to our ability to navigate complex regulatory pathways and deliver consistent results.
Our facilities undergo frequent inspections by major global regulatory agencies, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and South Korea’s Ministry of Food and Drug Safety (MFDS), ensuring compliance with international standards. These inspections, along with client audits, not only affirm the quality and reliability of our processes but also facilitate faster regulatory approvals globally.
Collaborating with Samsung Biologics offers significant advantages to biopharmaceutical developers. It enables them to leverage our recognized expertise and compliance record to their benefit, ensuring their products reach the market more swiftly and smoothly.
Adapting with Agility and Flexibility
Navigating the evolving landscape of compliance requirements is a critical challenge in biopharmaceutical drug development. As industry knowledge deepens and new manufacturing and analytical technologies are introduced, improving processes and products that maintain safety and efficacy becomes essential. Agile and flexible manufacturing solutions are indispensable for adapting to regulatory changes and clinical trial results.
CDMOs play a crucial role by providing the necessary flexibility to support supplementary regulatory filings throughout the life cycle of a product. This includes process and facility modifications aimed at enhancing patient access and extending the commercial success of client products. At Samsung Biologics, we swiftly adapt to evolving regulatory demands with tailored manufacturing solutions that we design to meet these changes.
Our extensive experience with regulatory filings, including INDs and BLAs, informs our strategic approach. We ensure comprehensive document preparation and optimize client submission packages. This proactive stance significantly reduces queries from regulatory authorities, streamlines the review process and, crucially, minimizes delays.
In one example, a mid-sized biopharma client encountered a setback when the FDA issued a complete response letter due to a chemistry, manufacturing, and controls (CMC) issue in the client’s BLA submission. In response, the biopharma company formulated an aggressive remediation strategy and chose Samsung Biologics for its proven flexibility and regulatory acumen. We were tasked with preparing for a site addition immediately after the approval of the resubmitted BLA. Our ability to update the process and regulatory documentation in real time during the BLA review played a pivotal role. Thanks to our experienced regulatory team and agile processes, the drug not only overcame regulatory hurdles but also achieved blockbuster status, significantly impacting the lives of patients.
Seamless Support from Development to Post-Approval
Samsung Biologics offers tailored solutions spanning the entire biopharmaceutical development process — from cell line development to final aseptic fill/finish. Our extensive suite of innovative, proprietary technology platforms and advanced laboratory testing services allows us to expedite the development of a wide range of biologic candidates. This includes standard monoclonal antibodies as well as complex biosimilars, such as multispecific antibodies, fusion proteins, and antibody-drug conjugates. We guide these candidates seamlessly from initial clinical trials through to late-stage development, regulatory approval and, ultimately, commercial launch.
When supporting these efforts, our regulatory affairs services are comprehensive, covering every phase from early development to post-approval. These include meticulous document preparation, strategic regulatory reliance planning, and maintaining an up-to-date understanding of the evolving regulatory landscape focused on patient-centered drug development. Our capabilities in Common Technical Document (CTD) authoring, the handling of Information Requests (IR), preparation for inspections, and consultation on CMC issues illustrate our depth of support. Additionally, we offer ongoing GMP renewal, proactive monitoring, and planning for upcoming regulatory changes.
Our regulatory teams are deeply involved in all aspects of process development and manufacturing. This involvement ensures they possess detailed product and process knowledge, which is crucial for providing seamless, informed regulatory support throughout the life cycle of a product. Such comprehensive oversight and expertise enable Samsung Biologics to not only meet but also exceed the expectations of our partners and regulators, ensuring the swift and successful market entry of new therapies.
Staying Ahead of Key Trends and Evolving Regulations
The biopharmaceutical industry is currently undergoing significant transformations, with a notable shift toward biologics, advanced therapies, and personalized medicine. Drug developers are navigating increasing technical complexities, new challenges, and stringent regulatory hurdles. These must be managed efficiently to maintain high quality and cost-effectiveness all within compressed development timelines.
As the industry’s needs evolve, the demand for CDMOs to provide comprehensive support throughout the drug development and commercialization cycles intensifies. State-of-the-art analytical, process, and formulation development capabilities, alongside advanced manufacturing solutions and proactive regulatory support, become crucial.
At Samsung Biologics, we possess all these capabilities and more. Our extensive global experience equips us to effectively anticipate and respond to regulatory challenges, including the intricacies involved with advanced modalities such as mRNA, antibody–drug conjugates, and multispecifics. Our track record of securing hundreds of product approvals has honed our ability to navigate the complexities of commercialization and market access, ensuring the successful launch and life cycle management of even the most challenging products.
Clients also recognize and value our commitment to sustainable regulatory practices, which not only meet current standards but also anticipate future regulatory trends. This proactive approach ensures that our partners are well-prepared for upcoming changes and can maintain a competitive edge in a rapidly evolving marketplace.
Partnering for Success: Beyond Compliance to Market Leadership
Ensuring regulatory compliance from the very beginning is foundational to successful drug development. There are no shortcuts; attempting to bypass regulatory requirements or engaging in inadequate planning can significantly derail project timelines, increase costs and, at worst, lead to project failure.
Adopting a right-the-first-time approach to development, manufacturing, and regulatory compliance is crucial. For biopharmaceutical companies partnering with outsourcing services, choosing the right CDMO with a robust track record in these areas is not just beneficial but also essential. Samsung Biologics demonstrates its prowess with years of experience, a solid track record of approvals, and a commitment to comprehensive regulatory support. Our competitive advantages and depth of knowledge enable Samsung Biologics to effectively assist clients in advancing both traditional and novel biologic candidates from the lab to the market, and ultimately to patients.
By partnering with Samsung Biologics, clients gain more than just a service provider; they gain a strategic ally equipped to navigate the complexities of global regulatory landscapes, ensuring smoother transitions from development phases through to successful commercial launches.
References
1. Playter, Grant. “Investigating Outsourcing.” BioPharm International. 36: 10–12 (2023).