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Editor of Pharmaceutical Technology Europe
The huge potential of biopharma is presenting an important epoch for outsourcing partners that can support the development and manufacture of biologics in an efficient way.
Editor’s Note: This article was published in Pharmaceutical Technology Europe’s March 2020 supplement.
As the biologics and biotech sectors continue to propagate, so too will the demand for biopharmaceutical outsourcing services. Growth in the demand for outsourcing partners will be driven by factors such as a lack of in-house manufacturing capacity, the requirement for more external expertise and knowledge, as well as a need for greater return on capital, as reported by Deloitte (1).
To learn more about the opportunities for outsourcing partner companies and industry trends within Europe in the exciting field of biopharma, Pharmaceutical Technology Europe spoke with Dámaso Molero, CEO at 3P Biopharmaceuticals-a contract development and manufacturing organization (CDMO) that specializes in the process development and manufacture of biologics and cell products.
PTE: Could you briefly overview some of the key opportunities for European outsourcing companies within the bio/pharma industry?
Molero (3P Biopharmaceuticals): Nowadays, there is a great demand for the biologics sector, and the loss of patents for very important molecules has opened up the possibility of developing biosimilars. As a result, many biopharmaceutical start-ups are emerging in today’s market, and it is not possible for each one to set up their own manufacturing site. For this reason, there is a reliance on specialized companies, such as 3P Biopharmaceuticals, that can support development and manufacturing of biologics while at the same time helping with any difficulties that may arise and performing the activities in a more efficient, fast, and cost-effective manner.
Currently, advanced therapies are also experiencing growth in the market. These therapies include not only classic gene therapies, but also specialized immunotherapies, such as chimeric antigen receptor T-cell therapy (CAR T cells), and new techniques of gene editing (e.g., clustered regularly interspaced short palindromic repeats [CRISPR]) that will enable more selective therapies adapted to the patient. Tailored or personalized medicine demonstrates a huge potential for the industry and patients, so without any doubt, we are heading into an important epoch for biotech.
Considering the enormous opportunities currently offered by biotechnology, there is great potential for Europe because companies can, for example, develop treatments for the so-called ‘rare diseases’, or those without current therapeutic approaches. In this regard, there are opportunities to participate in the advancement of personalized medicine or the regulatory development of cellular and gene therapies. Moreover, there is great opportunity related to the generation of new technologies that allow the development and manufacture of drugs at a lower cost, to reduce health expenditures for administrations, or expansion of the frontiers of tissue engineering as a future alternative to conventional treatments or as a substitute for organ transplantation, and so on.
Therefore, there are many applications that biotechnology can offer for the research of new treatments, reduction of health costs, and/or creation of specialized employment. This translates into a bright and promising future for the sector.
PTE: Are there any European industry trends that have given/are giving rise to shifts in the expectations of sponsors on outsourcing partners?
Molero (3P Biopharmaceuticals): For biopharmaceutical companies with promising pipeline candidates, the preferred scenario is trying to decrease the development time as much as possible because time-to-market is a fundamental consideration. This time pressure can boost the need for outsourcing and/or increase general R&D expenditures as companies must continuously invest in improving development platforms and seeking new technologies or strategies to achieve market requirements.
Additionally, as patents expire, clear opportunities for biopharmaceutical companies to shift their strategic focus to incorporate biosimilars into their pipeline are opened up. In such cases, companies entering the biologics sector typically outsource the development and manufacture of products because they are usually coming from the world of small molecules or generics and do not possess the necessary capabilities in-house. Therefore, this trend increases the demand for CDMOs, such as 3P Biopharmaceuticals, that specialize in the development and manufacture of biologics.
PTE: What are the benefits of a ‘one-stop-shop’ style outsourcing partner?
Molero (3P Biopharmaceuticals): As a ‘one-stop-shop’, partner companies can offer an integrated service for the process development and GMP [good manufacturing practice] manufacturing of biopharmaceutical products. At 3P Biopharmaceuticals, for example, this integrated service includes manufacture using microbial and mammalian expressions systems. With an integrated service, the customers’ biological drug manufacturing needs can be covered during any stage of biopharmaceutical development, from the earliest stages of drug development, through to CGMP [current good manufacturing practice] manufacturing for clinical studies and commercial production.
This strategy favours the streamlined control of the process, and because all activities are centralized, it can enable a global vision for all project needs, save time and costs, and foster direct, effective communication between partners. Therefore, a very important aspect of the ‘one-stop-shop’ model is that it naturally supports the establishment of partnership relationships rather than customer and subcontractor relationships.
PTE: What trends do you believe will be seen within European bio/pharma outsourcing in the near future?
Molero (3P Biopharmaceuticals): It seems that there will be an increasing demand for the manufacture of biosimilars, which is a great opportunity for CDMOs, as well as the fact that in-house pre-clinical development services and technology transfer are translated into higher overhead costs for bio/pharma companies compared to outsourcing. Moreover, biotechnology for new biological entities has great potential because novel drugs, for example, can be developed for so-called ‘rare diseases’ or those without treatment through innovative advancements in personalized medicine, cell and gene therapy approaches, tissue engineering, and so on.
As a result, biotechnology provides us with many opportunities to research new treatments, reduce costs, and create highly specialized employment opportunities. The future opens an incredible opportunity for developing new biologic treatments, which can improve the health of millions of people.
1. Deloitte, “2020 Global Life Sciences Outlook,” deloitte.com, Industry Analysis, 10 Jan. 2020.
Pharmaceutical Technology Europe
Supplement: Partnering for Bio/Pharma Success
When referring to this article, please cite it as F. Thomas, “By Popular Demand: The Growth of Biopharma Outsourcing,” Partnering for Bio/Pharma Success Supplement (March 2020).