Technology outsourcing is an effective way to gain in-depth biotechnology, but dependence on external resources may limit knowledge within the organization. Is there a way to achieve the best of both worlds?
Author: Nick Hutchinson, Floris De Smet, Miriam Monge
The development of the most efficient and effective biological process can increase the productivity of the company's biological agents and reduce the cost of its products, thereby enhancing competitiveness. Unfortunately, it is difficult to know. A true understanding of biotechnology and its optimization requires superior technical capabilities. The ability to develop these capabilities within the enterprise is costly, and usually only biopharmaceutical companies with strong strengths and sufficient funds will choose to do so. Another way is to outsource production and take advantage of the expertise of contract manufacturers. But outsourcing in this way may limit the ability to improve within the enterprise, resulting in dependence on external production partners, which is not an ideal situation for all companies.
Talent battle
Not long ago, the development of biopharmaceutical production processes focused primarily on the speed of process development to allow new biologics to enter the clinic as quickly as possible. The importance of entering clinical speed has not been reduced to this day, but today companies are also aware of the benefits of a well-developed and highly optimized process that is as efficient as possible and does not affect product quality. The higher the efficiency of the bioprocess, the lower the cost of the commodity. This is critical because the industry is in an increasingly competitive environment. More and more biosimilar drugs have entered the market, and they have taken a certain market share at a lower price because they are far lower than the research and development costs of the original research drugs. Companies with innovative drugs need to reduce their production costs as much as possible to reduce the impact of competition from low-price biosimilars.
One of the main ways to improve the efficiency of biological processes is to apply new technologies, such as process analysis technology, to effectively improve the performance of biological processes. But applying new technology is no easy task. There are more and more novel and complex tools and technologies in the biopharmaceutical field, but engineers with these skills and knowledge are limited. Objectively speaking, due to the rapid expansion of the industry and the reliance on employees with scientific and engineering skills, biotechnology companies are busy with a “talent battleâ€. Industry surveys highlight the difficulties managers are experiencing to fill job vacancies. This issue has been discussed in the June issue of The Medicine Maker. This problem may have to continue for some time, especially when students in science and engineering majors in secondary schools and universities seem to be lacking.
Large biopharmaceutical companies with strong biopharmaceutical R&D product lines are more likely to have internal resources and build larger cross-functional teams that can apply advanced development and production technologies. So how about a small business? These companies may only be able to make limited investments within their capabilities, but we have also noticed that many new drugs are now developed by these small businesses (3).
The bag VS outsourcing
As mentioned above, through outsourcing, companies can acquire biotechnology talent without internal input. Since the Contract Development and Production Organization (CDMO) has ready-made production assets, small companies often work with CDMO to get into the clinic quickly (4). CDMO must increase its investment in process research to remain competitive and often implement new processing technologies quickly. As CDMO works with many customers, they tend to have a wealth of experience in new technologies, new project types and bioprocess development.
But outsourcing also has its shortcomings. The bioprocessing capabilities provided by contract manufacturers may never be internalized. When transferring responsibility for process innovation to a CDMO, there is a danger that outsourcing becomes a necessity from one choice (5). Biopharmaceutical companies that increasingly rely on CDMO partners are bound to struggle in their negotiations on commercial terms.
In some cases, the manager makes the decision to commission the contract production service, and decides that the production will never be carried out within the enterprise, which can achieve good results. But for other companies, the choice to keep in-house production activities one day in the future is of real value.
It is also possible to find a compromise between internal development and outsourcing, and to introduce process development activities within the enterprise by introducing professional skills and process knowledge. This means that third parties advise on bioprocess development, process scale-up, implementation, and any regulatory issues. One of the biggest benefits of this type of cooperation is that companies can absorb relevant knowledge and enhance their internal biopharmaceutical production capacity. Many development activities can benefit from this approach: for example, process modeling, cell line development, cell bank setup/testing, analytical method development, high-throughput upstream/downstream process development, and process analysis techniques. Whether it can be achieved depends on the company and the partners it chooses.
Key to cooperation
It is well known that in any insourcing cooperation, a strategic and forward-looking approach is essential to achieve optimal benefits. But in practice it is often necessary to apply a more specific approach. Here we offer a few suggestions.
The ideal time for managers to develop their collaborative programs is in the early stages of drug development. Gap analysis should be used to identify the knowledge that is needed and that is currently lacking within the company. When looking for in-house partners, we recommend not only to look at their professional skills, but also to focus on their ability to work across geographies. Once a partner is selected, expectations, project goals, deliverables, milestones, and time nodes should be identified. It's also important to remember that while using external experts means you don't have to hire additional full-time employees, you need to allocate internal resources to manage this relationship.
Once you have established a substantial partnership, you need to consider how the organization absorbs the knowledge generated. For most companies, the ultimate goal of choosing this type of outsourcing is to develop new capabilities and expertise. A knowledge management system is required to achieve project results. This is by no means a simple report archive; key knowledge points must be identified and effective methods for efficient dissemination of these knowledge points within the organization. It is a good way to combine more formal methods such as internal seminars and other methods of dissemination of information and “learning lessonsâ€. External experts can also provide advice on high fit training programs. In fact, we recommend that the program be a foundation for process development and new technology implementation strategies.
Knowledge is power – access to important process development expertise can help small biopharmaceutical producers compete with large companies.
about the author:
Nick Hutchinso is the Technical Content Marketing Manager, Floris De Smet is the North American Manager of the Process Development Consulting Team, and Miriam Monge is the Global Director of the Process Development Consulting team. All three authors are members of Sartorius Stedim Biotech Germany.
references:
1. E Langer, BioProcess International, “Hiring and Staffing in Biopharmaceutical Manufacturing: Five-Year Trends Indicate Difficulty in Filling Positionsâ€, (2016). Available at: http://bit.ly/1p2aYGz. Accessed August, 26, 2016 .
2. K O'Driscoll, “Train and Retainâ€, The Medicine Maker, 20 (2016). Available at: http://bit.ly/2b37C2m
3. B Speder, “Making Small Biotech Workâ€, The Medicine Maker, 18 (2016). Available at: http://bit.ly/2c0YwUA.
4. N Walker, Contract Pharma, “Single-Use Technology Integral to Advancing Biomanufacturingâ€, (2016). Available at: http://bit.ly/2bLeUIy. Accessed August, 26, 2016.
5. CM Christensen, “Principles of disruptive innovationâ€. Presented at The Liverpool Summit – Transforming the Future; October 1-2, 2008; Liverpool, UK
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