Outsourcing Formulation Services for Biologics

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For the past few years, with the advent of the COVID‑19 pandemic, there has been a rapid influx in investment into therapies that can treat and help alleviate symptoms of the respiratory disease, SARS‑CoV-2. Growth in the development and manufacturing of specialized vaccines has driven growth in the outsourced services markets, particularly for formulation development activities (1).

In addition to the driving force of the pandemic, new generation drug molecules are becoming ever present in the development pipeline to tackle the rising levels of chronic and difficult-to-treat diseases. This expanding proportion of complex compounds is also influencing a greater need for more specialized formulation approaches, the expertise for which is not always available as an internal resource at a company, leading to more reliance on outsourced service providers.

To learn more about the changes impacting the outsourced biopharmaceutical formulation development market, BioPharm International® spoke with Robert Gustines, senior vice president of Commercial Operations at Bora Pharmaceuticals, and Paresh Vadgama, fellow scientist, Biologics Product Development, Catalent.

Increasing demand

BioPharm: Could you provide an overview of the key drivers for the outsourcing formulation development market?

Vadgama (Catalent): Formulation development is a niche area within pharmaceutical drug development, with biologics formulation development in particular requiring specialized resources in terms of well-trained scientists, high quality ingredients, and advanced instrumentation. There are many drivers that fuel formulation development outsourcing, but two remain key.

First, there is an increasing demand for novel drugs to treat chronic and life-threatening disease conditions. Many new generation molecules require complex development and manufacturing processes, forcing the need for additional capital investment, including capability and capacity expansions. Additionally, more of these products are being marketed utilizing advanced delivery systems, such as auto-injectors, to help improve patient compliance.

Second, there is constant pressure to shorten the drug development timeline to bring therapies to patients faster, while remaining cost-effective. This pushes organizations to judiciously rationalize in-house activities, while outsourcing high capital and resource draining activities such as formulation development.

Gustines (Bora Pharmaceuticals): Biotech and pharmaceutical companies continue to look to outsourcing as a way to reduce risk, and save both time and money during drug development—especially in the earlier pre-clinical phases. What’s fueling growth in the formulation development space is the rising need for novel medicines as a result of a significant burden of infectious and chronic diseases, with oncology remaining a central focus and accounting for over a third of drugs in the pipeline globally.

Impact on services

BioPharm: How has the increased attention on large molecule/biologics development impacted outsourced formulation services?

Gustines (Bora Pharmaceuticals): Large molecule development requires specialized expertise due to the formulation challenges associated with increasingly complex, highly engineered protein molecules—typically involving maintaining stability, achieving appropriate drug delivery, and optimizing protein structures. As a result, there has been a growing demand for contract development and manufacturing organizations (CDMOs) that possess the necessary expertise and infrastructure to handle the formulation development of biologics. For example, high concentration formulations are becoming increasingly common, and it will, therefore, become important to have a partner with expertise in this area of formulation development.

Contract partners that offer formulation services have responded to growing demand by investing in specialized equipment, facilities, and analytical tools required for working with biologics. Expert CDMOs should be in a position to provide a comprehensive range of integrated services, including cell line development, process optimization, analytical testing, and regulatory support, all with the flexibility to meet the specific
requirements of their client’s drug substance and product.

Vadgama (Catalent): The COVID-19 pandemic served as a catalyst that brought significant changes. Organizations with novel technologies and scalable solutions grew rapidly, and CDMOs that were often seen as finished product suppliers, became recognized as product development partners. A further consequence was that regulatory bodies began to increasingly work in-tandem with developers, to ensure a rapid review of quality and safety data.

Though drug development is a lengthy and highly regulated, yet uncertain pathway, formulation development services are gaining greater attention. Small biotech companies, with limited capital and technical expertise, are particularly reliant on outsourcing partners to support the development of their product pipelines. Some CDMOs, such as Catalent, can provide a ‘one-stop-shop’ integrated approach to simplify this process for smaller sponsor companies, while also cutting product development costs.

The lessons learned from the COVID-19 crisis are fostering innovation-based ecosystems within CDMOs to stay agile as they tackle technologically superior, highly complex biologics such as antibody-drug conjugates, mRNAs [messenger RNAs]/lipid nanoparticles, and adeno-associated viruses, including their formulation development. There is clearly a growing market emerging for outsourcing partners in this area which will become increasingly apparent over the coming few years.

Best practices

BioPharm: Are there any best practices you could share for companies looking to outsource formulation development of large-molecule drugs to an outsourcing partner to ensure success?

Vadgama (Catalent): Some recommendations to ensure successful outsourcing of formulation development include careful selection of a partner depending on skillsets, reputation, and credibility, and working out a detailed plan in advance.

Scientific expertise and technical experience are the main elements of a product’s success. Careful selection of an outsourcing partner that has the right skillsets, is adaptable to project changes, has a successful delivery track-record, and is willing to innovate, is critical.

Ensuring that the chosen outsourcing partner has a reputation for clear and regular communication is of the utmost importance to build trust between both parties, especially during long-term projects involving
significant investments.

Identifying a credible outsourcing partner that will apply prior knowledge, published literature or improvements made outside of its organization to reduce potential risks and optimize costs for its client, is another vital practice.

Working out an early, detailed outsourcing plan with key milestones, timelines, and deliverables is definitely recommended. For example, having a quality target product profile helps to develop product characteristics and decision workflow.

Gustines (Bora Pharmaceuticals): Companies looking to outsource the formulation development of large-molecule drugs to an outsourcing partner must evaluate a number of ‘hygiene’ factors first (i.e., fundamental requirements that must be met before a partnership should be considered).

Firstly, the CDMO must have relevant expertise and experience, and a proven track record in successfully developing formulations for large-molecule drugs and a portfolio of similar projects. Next, the CDMO must have (or be investing in or acquiring) the necessary infrastructure, equipment, and capabilities to support large-molecule formulation development. This includes technologies and analytical tools for characterization, facilities, and cleanrooms specified for handling sensitive molecules.

Companies need to verify that the outsourcing partner has a thorough understanding of the regulatory landscape and intellectual property protections in place.

Key benefits

BioPharm: Could you outline the key benefits for outsourcing formulation development?

Gustines (Bora Pharmaceuticals): Outsourcing demand for formulation development is shaped by several key drivers. For example, the economies associated with outsourcing to specialized partners rather than investing in establishing in-house capabilities. Outsourcing allows them to reduce infrastructure costs and access expertise, state-of-the-art technologies, equipment, and facilities without capital investment.

Speed-to-market is a crucial success factor in the life sciences. Outsourcing formulation development can expedite the drug development process by leveraging existing infrastructure, expertise, and streamlined processes. Additionally, CDMOs offer flexibility and scalability in resource allocation, allowing pharma and biotech companies to adjust their outsourcing requirements based on the specific needs of their development pipeline.

Finally, the understanding of regulatory requirements and quality assurance practices of CDMOs allows their clients to leverage this expertise to streamline their submissions, reducing the risk of regulatory hurdles and delays.

Vadgama (Catalent): Formulation development is a complex and expensive process, requiring comprehensive knowledge of excipients, dosage form characteristics and patient-specific drug delivery customization. Key benefits can be expected when outsourcing formulation development, including cost minimization, gaining a competitive advantage, and improved efficiency.

Cost minimization. Outsourcing provides easy access to highly specialized technologies and expertise, while reducing routine operational and capital expenses including laboratory rent, utilities, instruments, general maintenance, and employees’ salaries.

Gaining competitive advantage. Many outsourcing partners offer integrated, wide-ranging formulation development solutions that use high throughput screening and analytical technologies. Leveraging their vast prior knowledge and adopting the latest innovations, they look for continuous improvements. Customers can benefit from these advancements to make better decisions and stay ahead of their competitors.

Improved efficiency. With platform approaches, qualified infrastructure, optimized inventory, and in-house expertise, an outsourcing partner can readily develop formulation solutions to move quickly into clinic. This allows clients, especially small/virtual companies, to focus on core areas and optimize cash flow while seeking growth opportunities.

To meet the rising demand for outsourced formulation services, especially in support of next-generation biologics, this sector will continue to see heavy investments and growth in the near future. Also, this space is rapidly experiencing the adoption of data analytics technologies, providing greater scientific insights for improved data-based decision-making.

Reference

IQVIA. Global Trends in R&D 2023.Activity, Productivity, and Enablers. Institute Report. Feb. 15, 2023.

About the author

Felicity Thomas is the European/senior editor for BioPharm International.

Article details

BioPharm International
Volume 36, No. 9
September 2023
Pages 39-41

Citation

When referring to this article, please cite it as Thomas, F. Outsourcing Formulation Services for Biologics. BioPharm International 2023 36 (9) 39-41.