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How can small biopharma use end-to-end CDMO partnerships to accelerate development?

By Andrew Warmington

Manufacturing Editor | Citeline

There is growing evidence that pharma and biotech companies in general, and small biopharmas in particular, are increasingly looking at ‘end-to-end’ partnerships with contract development and manufacturing organizations (CDMOs) for the outsourcing of drug development. It is also clear that a growing number of CDMOs are adding to their range of capabilities in order to address that need.

A recent survey by Citeline in partnership with a large CDMO found that there are multiple reasons why pharma companies of all sizes might choose end-to-end CDMO partnerships. The largest percentages (25% each) mentioned cost-efficiencies and accelerated processes as being among the three most important benefits, while 16% each chose simplified technology transfers and a reduced need for overseeing partnerships. The functions outsourced included clinical research (cited by 20%), clinical manufacturing (15%), commercial manufacturing (13%), and packaging (13%).¹

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Small biopharmas, who now account for over two-thirds of the early drug pipeline, are more dependent on outsourced partnerships than their larger counterparts: 57% of small biopharmas participating in the survey said they were outsourcing more than half of all drug development. Only 29% were investing in their own manufacturing capabilities, compared with 47% of the mid-sized and 83% of the large pharma organizations, respectively.¹

The main reason small biopharmas outsource more is because many of them have limited or no in-house capabilities in manufacturing, QA/QC, regulatory, and other areas. (Of course, there are exceptions. For example, GenVivo, a California-based biopharma focusing on gene therapies for cancer, decided to build its own QA/QC function and Phase I manufacturing facility in order to secure access to these functions when demand was high and capacity at CDMOs was low, causing long delays.)

Small biopharmas are also relatively likely to be developing more complex molecules, involving more manufacturing steps. The advance of technology has opened up more potential targets, meaning that both drug substance synthesis and the development of dosage forms will both become more complex still. These drugs tend to have more precise target product profiles and smaller potential markets in volume terms.

Moreover, small biopharmas’ clinical milestones are accelerated and frequently tied to funding. The name of the game is getting to the next milestone fast in order to go back to the market for more. A study by the Tufts Center for the Study of Drug Development (CSDD) in 2021 found that by partnering with a single CDMO, biomanufacturers could shorten timelines by an average of 14 weeks, reduce costs by almost $21 million, and increase net revenues by almost $24 million.³

Where small biopharmas are looking at fast-track approvals and/or to be first to market with a drug for an entirely new indication, speed is even more of the essence. In addition, as funding recovers from the post-COVID slump, some are now seeking to take their compounds all the way through to launch rather than license or sell them to a Big Pharma company after Phase II. All these factors are shaping the decisions these companies must make about partnering.

67% of respondents said that effective communication from CDMOs is critical and, broadly speaking, it is easier to communicate, and plan any necessary changes, with a single vendor than a network of suppliers. When a partnership is formed early on, there is no need for the CDMO to relearn the product history or carry out complicated technical transfers.¹

Drug developers in general find CDMO support most helpful in the early stage. Of those surveyed, 33% said product development and characterization was the stage where it was most important, while the same number chose the clinical manufacturing stage and 22% plumped for commercial manufacturing. In all, 62% preferred to approach partners in the early development stage.¹

However, throwing everything ‘over the fence’ is not a panacea. Almost all large CDMOs are multi-site networks that need to be managed carefully, just like multi-vendor networks.

It is very difficult for the client, especially a small one, to know how well integrated all of the necessary functions, from project management to quality systems and data management, really are behind the scenes. Some CDMOs have developed a package of services to address this need, such as Lonza with its SimpliFiH suite of first-in-human clinical services, incorporating API synthesis, solid form services, bioavailability enhancement, drug product manufacture, and CMC and regulatory services.

As well as checking that the CDMO can meet the phase-appropriate needs of the client and the specific molecule, biopharmas must ask other questions of its QA function. These are many and complex, for instance:

  • Does QA monitor incoming raw materials closely enough, particularly with regard to animal-derived raw materials that may contaminate a system?
  • Has the CDMO qualified all suppliers of raw materials and equipment to be used in the manufacturing process, and any intermediaries used?
  • Does the CDMO have the appropriate storage capabilities for the specific materials?
  • If, as is normally the case, the CDMO contracts out testing, has it qualified the contract testing organization (CTO)?

Conclusion

The decisions that small biopharma companies face when choosing a CDMO and the kind of partnership it wants are not easy. Sometimes they can make or break the company. Timing the start of the relationship can be just as important as finding the right CDMO. There is not, and never will be, a ‘one-size-fits-all’ solution for every client, let alone every project.

Nonetheless, utilizing end-to-end CDMO partnerships, when done properly, can be a great way for small biopharmas to accelerate the development of their projects. By talking to providers as early as possible in the development and manufacturing process, they can identify challenges earlier, be prepared for the inevitable bumps in the road, transition seamlessly between phases and ultimately save on both time and costs.

Evaluate Pharma’s CDMO Intelligence is a valuable tool for the crucial decision-making when it comes to choosing how, where, and when to outsource a drug development project. Users can access CDMO screening, as well as molecular landscape insights, detailed manufacturing capabilities, and accurate volume forecasts, all backed by gold standard financial forecast methodologies, so you can identify potential risks and mitigate them effectively to maximize your chance of success.

For more information, go to: https://www.evaluate.com/solutions/product-cdmo/

References:

  1. Are End-To-End CDMO Partnerships The Solution To Drug Development And Manufacturing Upheaval? White Paper: https://www.cambrex.com/insights-resources/end-to-end-cdmo-partnerships-solution-drug-development-manufacturing-upheaval/
  2. L. Garguilo, CDMOs “Bumping” Cell And Gene Companies, Outsourced Pharma, 8 July 2021: https://www.outsourcedpharma.com/doc/cdmos-bumping-cell-and-gene-companies-0001
  3. Tufts CSDD, Cost to Develop and Win Marketing Approval for a New Drug is $2.6 Billion: http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study

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