Integrated CMC Solutions in the Complex Biologics Space
The biopharmaceutical industry is undergoing a shift propelled by intricate biologics and their impact on global healthcare. With advancements in technology and subsequent therapies, particularly in antibody-based therapeutics, the industry’s landscape is witnessing a surge in innovative modalities, such as bispecific antibodies (BsAbs), reshaping treatment methodologies and market trajectories.
The rise of complex biologics has not only revolutionised therapeutic approaches but also triggered a significant economic surge. The global antibody-based therapy market, estimated at $186 billion in 2021, foreshadows an upward trajectory, projected to grow at a compound annual growth rate of 13.2% from 2022 to 2028. The projected growth is attributed to the influx of novel therapies that are viable treatment options for a range of conditions, from cancer to autoimmune and neurodegenerative disorders.
In this article, Jimin Kim, Senior CDO Business Strategist at Samsung Biologics, lays out the challenges of successfully progressing complex biologics from clinic to commercialisation. He also discusses the difficulties associated with the evolving biologics space and highlights the importance of partnering with an expert contract development organisation (CDO) in end-to-end drug development/manufacturing.
The Rise of a New Era of Antibody-Based Therapies
The emergence of complex molecules highlights a pivotal shift in the therapeutic landscape, embracing a future of precision medicine tailored to address the intricate complexities of various diseases. BsAbs are meticulously engineered to simultaneously bind two distinct antigens, combining heightened precision and efficacy in targeting specific disease pathways. Their remarkable ability to target multiple antigens holds promise across many areas of healthcare, including oncology, immunology and infectious disease research. By overcoming the limitations of conventional approaches, BsAbs pave the way for novel treatments, particularly for conditions resistant to traditional therapies. BsAbs herald a new era of personalised medicine that optimises therapeutic outcomes.
As in the case of BsAbs, the rise of these new antibody-based therapeutic modalities suggests a new era where therapies are designed to precisely target the unique molecular underpinnings of complex diseases, ultimately improving treatment efficacy and patient outcomes.
Challenges in Complex Biologics Development
While BsAbs are entering a promising new healthcare era, their development and manufacturing intricacies pose formidable challenges. Creating BsAbs demands sophisticated processes that surpass the complexity of traditional monoclonal antibodies (mAbs).
In contrast with established monoclonal antibody production processes, the standardisation of complex biologics’ development lacks uniformity. This can result in project delays and uncertainties, which can be costly.
Multiple complexities can arise during biologic manufacturing, from intricate expression systems to ensuring correct assembly and mitigating impurities. The intricate nature of BsAbs increases operational costs, requiring substantial investments in infrastructure and specialised expertise to ensure efficient and cost-effective production.
Maintaining the structural integrity of complex biologics like BsAbs is crucial for therapeutic efficacy and economic viability. Ensuring correct assembly to preserve binding affinity and effective function requires meticulous quality control measures. Any challenges in this area jeopardise patient safety and can result in significant financial problems including product recalls, increased regulatory costs and compromised market positions.
Consistent and substantial production yields must be ensured to meet the rising clinical demand for BsAbs. Achieving high production yields while maintaining production costs is difficult and requires a delicate balance. If these hurdles are not overcome, both clinical trials and commercial-scale manufacturing can be negatively impacted by costly delays.
Immunogenicity and shelf life must also be balanced to safeguard efficacy and safety while maximising the commercial lifespan of biologic therapeutic products. It is essential to ensure a stable shelf life to extend a product’s economic viability, avoiding financial losses associated with expiration or degradation.
Strategic CMC Solutions in Biologics Development
Addressing these complexities requires end-to-end, strategic chemistry, manufacturing and control (CMC) solutions and innovative approaches to ensure success as the project progresses:
Implement process standardisation and optimisation protocols to develop best practices to minimise delays and enhance efficiency.
- Invest in cutting-edge technologies and robust infrastructure to streamline expression systems, achieve better quality control and manage operational costs.
- Introduce stringent quality control to ensure correct assembly, maintain structural integrity and minimise impurities, mitigating risks to patient safety and avoiding financial setbacks associated with regulatory compliance issues.
- Perform early immunogenicity assessments to mitigate risks and ensure therapeutic efficacy and safety.
- Complete formulation development and stability testing to extend shelf life, enhancing the economic value of the product and avoiding financial loss due to premature degradation.
CDOs are crucial partners for overcoming challenges, offering expertise and integrated solutions to overcome biologic development hurdles. Championing collaboration between partners and emerging technologies early in the developmental process addresses complexities while upholding quality and adhering to strict timelines to market.
However, the focus is now extending beyond technological prowess, being placed instead on harnessing strategic partnerships to accelerate drug development. The economic implications of successful complex biologic development influence healthcare systems, affecting accessibility, affordability and market sustainability.
Aligning with Established Partners
As these advanced therapies proliferate the development pipeline, fostering alliances with CDOs equipped with contract development and manufacturing organisation (CDMO) capabilities becomes essential. Integrating CMC solutions with economic foresight can strengthen a biologics development strategy. CDOs can establish an optimised foundation to ensure success in end-to-end drug manufacturing.
In response to the challenges presented by biologics development and manufacturing, considering all aspects of complex biologic development is as pivotal as conquering scientific challenges. Addressing CMC considerations with technological innovation is shaping the future of healthcare, laying the foundation for a sustainable and accessible therapeutic future.