In addition to cell therapy contract development and manufacturing organizations (CDMOs), there are numerous companies that offer CDMO services for other types of biologics. Biologics are defined as human, animal, or microorganism derived products used for therapeutic purposes. In addition to cell therapies, biologics can include vaccines, blood and blood products, human cells and tissues used for transplantation, and gene therapies.
While the services provided by these companies are not cell therapy CMDO services, these companies should be monitored, because their manufacturing capabilities and experience with biologics may position them expand into cell therapy CDMO services in the future.
For example, KBI Biopharma, Inc. (KBI) started as a traditional pharmaceutical CDMO in 1996, then signed an agreement with Merck & Co., Inc. (known as Merck in the U.S. and Canada) to acquire Merck’s microbial process development and manufacturing operations in Boulder, Colorado, in May 2014. That expanded its KBI’s manufacturing operations from pharmaceuticals to biologics. Next, KBI acquired the laboratory and manufacturing facilities of Opexa Therapeutics in February 2017 to expand into cell therapy manufacturing.
A similar path was followed by WuXi PharmaTech, which began as a Shanghai, China based pharmaceutical CDMO. Originally, AppTec Laboratory Services operated as a service provider for the biopharmaceutical and medical device industries, offering testing, contract research and development, and biologics cGMP manufacturing services. By acquiring AppTec Laboratory Services in January 2008, WuXi PharmaTech formed WuXi Apptec, expanding its reach into U.S. biopharmaceutical CDMO services. With later construction of three manufacturing facilities in Philadelphia, WuXi AppTec expanded into a cell therapy CDMO services.
Of course, WuXi PharmaTech is a massive global conglomerate with net revenue over $3.27 billion, so diversification was part of its growth strategy. WuXi PharmTech has acquired dozens of global companies since it was founded in 2000. In contrast, KBI Biopharma is a smaller market player who is making a strategic choice to specialize in cell therapy manufacturing as a service offerings.
As described in these examples, the strategy of expanding from biopharmaceutical to biological to cell therapy CDMO services is a logical progression.
Below, a list of companies providing CDMO services for biologics is presented. While these companies are not cell therapy CDMOs, they are operating in “close proximity” to the market and could potentially expand into it.
List of CDMOs Specializing in Biologics Manufacturing
- Avid Bioservices
- Boehringer Ingelheim
- Catalent Pharma Solutions
- CMC Biologics
- Fujifilm Diosynth Biotechnologies
- iBIO
- IDT Biologika
- JHL Biotech
- Millipore Sigma
- Samsung Biologics
- Rentschler Biotechnlogie GmbH
Hi Cade.
Interesting article. What hasn’t crossed over yet in this field with the ‘”new players” is experience. It’s not so hard to build a facility and clean rooms. Anyone can hire a design and contracting firm to build out EU or US class manufacturing suites for cell therapies. But what’s needed is the experience to further develop the clients products, transfer technology and operate at high levels of regulatory compliance and cGMP’s not to mention understand all the new automation platforms and quality systems as well as retain high quality people.
That takes decades of collective experience with manufacturing staff, quality control and assurance staff and materials (think qualifying vendors and materials and the handling and segregating it). So it remains to be seen if just anyone can handle these products on the approaching commercial scale.