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Biologics Product Development Challenges: What to Know?


By Tony D'Amore

Strategic Advisor | BrevisRefero

LinkedIn Profile




Biologic products are pharmaceutical drugs that are derived from microorganisms, viruses, animal and/or human origin using a variety of biotechnology approaches. These include vaccines, cell and gene therapy products, recombinant proteins, and blood components. Over the years, an increasing number of biologic products have been licenced to prevent or treat potentially deadly diseases. The biologics market size is expected to grow from about $400 billion US in 2023 to about $600 billion by 2030. This was in part stimulated by the COVID-19 pandemic which created a large demand for biologics with the market being driven by growing investments from government agencies and public and private investors. In addition, there continues to be an increasing number of entrants in the field enabled by an increase in new technologies, the rise in the burden of chronic diseases, the loss of patent exclusivity of some of leading biologic drugs, and growing demand due to higher acceptability for innovative therapies.


The overall process for manufacturing a biologic product that is expressed from a microorganism or cell is essentially 5 main steps:

  • Making of master and working cell banks and seed stocks

  • Cell expansion and growth by fermentation/cell culture and expression

  • Cell harvest, lysis, and initial clarification

  • Purification, polishing, and buffer exchanges

  • Formulation and fill finish


When one decides to enter the biologics market, it is important to understand that on average it takes about 10 years to get a development product through to regulatory approval.

When one decides to enter the biologics market, it is important to understand that on average it takes about 10 years to get a development product from Phase 1: First in Human clinical trial through to regulatory approval. This does not take into consideration the 3–5 years that may be required in the initial discovery and early research phases to identify a potential product, which was discussed in more detail in a previous blog (https://www.brevisrefero.com/post/eureka-i-ve-discovered-a-drug-target-now-what). Over the years, the development timeline from discovery to market has not changed very much even with the introduction of new technologies. In addition, the average cost of developing a product to market launch is about $1 billion US. Clearly a lot of time and money is needed to develop a biologic product, so why does it take so long and what are some of the hurdles or hot points?


Are You Ready for the Clinic?


Phase 1 clinical trials generally can take 4-12 months to complete

Let’s say you have identified a potential product through your research work to prevent or treat a disease. You now want to test your potential product in a clinical trial. You have mapped out the steps as to when the clinical trials will be performed and the potential launch of your product. This is a great planning step as it gives direction and information to investors, but seldom are the best laid plans achieved for various reasons. The first step to test your potential product in the clinic is in a Phase 1 clinical trial. This will require an Investigational New Drug Application (IND) or Clinical Trial Application (CTA) (depending on regulatory jurisdiction) to test the biologic product in humans, and contains the Chemistry, Manufacturing, and Controls (CMC) section. To achieve a well-rounded CMC section for a regulatory submission an extensive body of development data, reports, protocols, results, process descriptions, demonstration of scale-up, GMP manufacturing facility information, equipment used, demonstration that quality and regulatory requirements have been fulfilled and safety concerns addressed, as well as other information, are required. Writing and submitting the CMC package is no easy task and is essential to gaining regulatory approval. Submission of a satisfactory CMC in support of Phase 1 clinical trials generally can take 4-12 months to complete, while trying not to impact your overall clinical timelines. For new entrants and small biotech’s, external consulting support in writing these documents, assessing quality, and supporting your regulatory strategy may be required and can be a good investment. This is in addition to identifying potential CDMO’s that may be needed to manufacture your product. Meeting key regulatory deadlines and getting to market ahead of the competition is crucial for ultimate success of the product.


There is a tendency, however, of sometimes moving too quickly without having foundational information needed to support the regulatory submission. For example, you may need to make significant changes in the process to increase productivity and yield or change the formulation conditions to stabilize the product. In either case, you may be required to repeat the safety studies and/or Phase 1 clinical trial. It’s important for a company to get to Phase 1 as quickly as possible, however one must understand the impact on future trials and timelines if information is missing or significant changes are made which could impact the timing of future trials and product launch.


Working with a CDMO requires developing a good working relationship to achieve a positive outcome, but equally important is creating a strong mitigation plan in the event of challenges or failure.

Many biotech’s and several large pharma companies use biologic CDMOs to help support the product development and manufacture of clinical product. This allows the sponsor company to focus on other priority projects such as advancing further research and provides for additional internal manufacturing and resource capacity. There are a number of very good CMDOs globally, however finding the right CDMO partner may not be that simple or fit within the planned project timeframe. It’s important to understand the CDMO’s capabilities, technical track record, quality systems, cost structure and availability. Working with a CDMO requires developing a good working relationship to achieve a positive outcome, but equally important is creating a strong mitigation plan in the event of challenges or failure. Changing CDMOs during the product development phase could also impact the timelines, as this would result in having to repeat tech transfer and ensure appropriate quality practices. In extreme cases a change in the CDMO partner may be necessary due to productivity constraints or manufacturing capacity availability, so it’s important to ensure that sufficient lead time and planning is allotted so that the timelines are not significantly impacted.


Product development speed is always an important factor in developing a product, however development speed is dependent on many factors. For small biotechs, it is important to ensure there is a well-developed plan to address the requirements for GMP manufacturing through a reputable CMDO for support of the manufacturing role to increase the likelihood of success of the program.



BrevisRefero Corporation is a collection of biologics drug development experts utilizing its collective 100+ years of experience in advancing our clients outsourcing objectives through its RFP>Navigator® portal to accelerate drug candidates efficiently into clinical trials.

If you would like a free, no-obligation consultation to talk about your biologic drug development outsourcing, planning, budgeting, or execution then please reach out to us at:


contact@brevisrefero.com or call us at (905) 636 - 6559.


Follow BrevisRefero on LinkedIn for more updates.




By Tony D'Amore

Strategic Advisor | BrevisRefero

LinkedIn Profile


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