The rapidly growing numbers of monoclonal antibodies (mAbs), fusion proteins and biosimilars produced by the pharma industry have greatly improved patient care and resulted in a proliferation of innovative treatment options. To date, there are over 100 biosimilars [1, 2], 162 mAbs  and over 11 fusion proteins  approved for therapeutic use.
These new therapeutic proteins are often more advanced than traditional monoclonal antibodies (mAbs), opening up exciting possibilities for enhanced life-improving therapies is truly exciting. As increasing numbers of biologic drugs lose patent protection, the development of becomes increasingly vital for pharma companies, healthcare systems and patients.
With a total of over 100 biosimilars approved by the Food and Drug Administration (FDA)  and over 90 by the European Medicines Agency (EMA) , the potential to expand patient access to life-saving treatments while also driving cost savings is growing.
Selecting the right contract development and manufacturing organization (CDMO) is a critical step in ensuring the successful development of biologics, as their expertise, flexibility, and regulatory compliance play a pivotal role in bringing high-quality and affordable therapeutics to market. A flexible platform approach for biologics development for both upstream and downstream processing can be truly advantageous.
This blog explores how a strategic approach — adapting programs for specific proteins and customer needs — can be beneficial in achieving the customer’s biologics development goals for novel therapeutics or biosimilars
The rising need for specific protein therapies in the pharma market
Advanced innovative new fusion proteins, bispecific and multispecific antibodies all play a crucial role in the pharmaceutical market. Fusion proteins and mAbs deliver targeted therapies potentially yielding more effective treatment outcomes with potentially fewer side effects compared to traditional non-targeted therapies. They are both also engineered to combine different protein components and can therefore be designed to target multiple molecular pathways in complex diseases. This provides a comprehensive therapeutic approach that addresses multiple disease mechanisms simultaneously.
Biosimilars, fusion proteins and mAbs are all complex to manufacture, so developers must have extensive experience and knowledge in navigating these processes. This expertise provides a clear grasp of the technical aspects and challenges associated with developing biologics, which can be applied to the development of novel molecules too.
Unlike generic drugs, which are chemically identical to their brand-name counterparts, biosimilars follow a more complex manufacturing process. As there is no way to guarantee they will be identical to the originator medicine, the approval process is complex. To demonstrate their similarity to a reference product, biosimilars must undergo rigorous comparative testing, including analytical and clinical evaluations, ensuring that any differences are not clinically significant for safety and effectiveness. It takes a specialized CDMO to understand the complexities of biosimilar development utilizing analytics in a comprehensive feedback loop with process development to achieve maximal biosimilarity.
Overcoming industry challenges
Regulatory requirements for biologics vary globally, which adds more layers of complexities when navigating approval processes. Therefore, selecting the best CDMO focuses largely on understanding global regulatory processes so the product can be guided through the approval process seamlessly.
Manufacturing biosimilars at large scales while ensuring quality and maintaining cost-effectiveness is another challenge. Overcoming these obstacles requires expertise, strategic planning and adherence to many regulatory standards.
Strategic help from a CDMO
Access to high-quality consumables, adherence to strict timelines and reliable performance are critical factors to consider in a CDMO. This is why biosimilars manufacturers should seek partners committed to quality, ensuring consistent results, minimizing delays and avoiding risks.
When strategically selected for partnership, CDMOs provide the necessary infrastructure, technical capabilities and quality systems to support biosimilar development. The suitability of a CDMO for helping to develop and manufacture biosimilars lies within their technical capabilities, adherence to current good manufacturing practices and flexibility. A critical skill for a development and manufacturing partner is that they have full understanding of how to use the analytics to drive process development in the direction of matching innovation. This skill comes from experience and also ensures that they have the analytical skills to develop novel highly engineered proteins.
Adapting programs to develop specific proteins
When selecting a CDMO for biologics development, it is essential to assess their capability to adapt programs to specific proteins and the customer’s individual protein requirements. Each biologic has unique characteristics, manufacturing needs and quality considerations. They can vary in terms of structure, stability, post-translational modifications and expression levels. A partner should have the capacity to customize its development programs to account for the specific attributes of a biologic and optimize the manufacturing process accordingly. This would include:
- Adjusting cell lines
- Adapting culture conditions
- Optimizing purification methods
- Performing extensive analytical techniques
By offering flexible programs, CDMOs can effectively address the distinct needs of different biologics, ensuring the successful development and manufacture of biosimilars and novel complex mAbs and mAb-like proteins.
To obtain the most successful biologics, integrated development solutions are essential. This includes streamlining upstream and downstream processes across cell line development and manufacturing. By offering a comprehensive range of services, a partner can provide a seamless experience and optimize timelines.
A CDMO should have a proven track record in analytical development, validation, in-process and release testing, stability studies, and formulation development for complex molecules. Their adaptability ensures that the unique characteristics of each protein are considered, maximizing the chances of success when going through clinical trials and to market.
Cohesive teams and specialized expertise
A differentiating factor among CDMOs is the cohesion and experience of their teams. Working with cohesive teams with extensive proficiency in many areas of the development process is highly beneficial when designing and producing biologics, particularly biosimilars.
- Complexity of Biosimilars: Demands expertise in areas like cell line development, process optimization, and regulatory compliance
- Team Cohesion: Promotes streamlined communication and efficient problem-solving, speeding up development timelines.
- Collective Experience: Equips teams to navigate biosimilar intricacies, anticipate hurdles, and implement best practices, raising approval chances.
- Long-term Collaboration: Enhances performance and communication for efficient project completion.
Moreover, unique capabilities — such as being able to develop and run cell-based bioassays — can be highly valuable. These assays are often challenging to source and integrate into the analytical process. A partner with in-house expertise in developing, validating and running bioassays can provide manufacturers with a distinct advantage, ensuring accurate and reliable product release testing.
Choosing the right CDMO is a strategic decision that can significantly impact the success of biologics development. By evaluating a CDMO’s ability to adapt programs to specific protein therapies and manufacturing needs, leverage specialized expertise, offer integrated solutions and overcome industry challenges, manufacturers can make informed decisions that maximize their chances of project success.
Remarkably, the Bora Pharmaceuticals biologics team has been working together for a decade. With expertise in analytical capabilities that have brought dozens of biosimilars to the clinic, the team has honed a robust platform approach for both upstream and downstream development. Bora’s success extends beyond traditional mAbs, as the company has extended its programs to include multi-specific monoclonal antibodies and monoclonal fusions. Leveraging their expertise, the team members can customize aspects of the platform to deliver optimal outcomes for their customers needs.
Find out more about Bora Pharmaceuticals’ biologics capabilities at https://boracdmo.com/biologics/
- Center for Drug Evaluation and Research. Biosimilar Drug Information [Internet]. FDA; 2023 [cited 2023 Jun 8]. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
- European Medicines Agency. Medicines [Internet]. 2023 [cited 2023 Jun 8]. Available from: https://www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Human/ema_group_types/ema_medicine/field_ema_med_status/authorised-36/ema_medicine_types/field_ema_med_biosimilar/search_api_aggregation_ema_medicine_types/field_ema_med_biosimilar