The biopharmaceutical industry has traditionally focused on developing blockbuster drugs. However, over the past several years, a new era of drug development has unfolded. Personalized medicine and orphan drug designation are now driving the industry to pursue increasingly complex development and manufacturing processes, resulting in the demand for CDMOs to offer specialized manufacturing capabilities and infrastructure. At the same time, the industry is focused on creating long-term partnerships with a just few CDMOs, who can provide the flexibility and expertise to meet the changing therapeutic landscape, in addition to a simplified supply chain.
In the following Q&A, Jean-Baptiste Agnus, Vice President of Global Sales and Marketing at Ajinomoto Bio-Pharma Services, discusses the value of partnering with a comprehensive CDMO such as Ajinomoto Bio-Pharma Services, to help drive your program to market.
Ajinomoto Bio-Pharma Services is an integrated CDMO. What is the focus of this organization?
JBA: As a full service CDMO, Ajinomoto Bio-Pharma Services has manufacturing sites in the US, Japan, Belgium and India, providing development and manufacturing services for large and small molecules, including ADCs, oligonucleotides and aseptic fill finish services. Our global infrastructure allows us to provide our clients accessibility to a broader range of service offerings, complementary solutions, and a single point of reference for an entire project.
How is Ajinomoto Bio-Pharma Services different from other CDMOs?
JBA: Ajinomoto Bio-Pharma Services is uniquely positioned to provide the adaptive solutions and responsive service that isn’t as possible at larger CDMOs, and our niche service offerings allows us to meet the various needs of our clients, such as continuous flow manufacturing, oligonucleotide and peptide synthesis, ADC process development and cGMP manufacturing. The core of Aji Bio-Pharma, however, is the culture and people. Our organization prides itself in being a leading, trusted and innovative partner for our clients. These values are something that we uphold and apply to every aspect of our work and are evident in all of our interactions.
Ajinomoto Bio-Pharma Services is part of the Ajinomoto Group. How does Aji Bio-Pharma leverage this relationship to benefit its customers?
JBA: The Ajinomoto Group’s R&D organization plays a large role in developing new concepts using for various bio-manufacturing applications, which we use throughout Aji Bio-Pharma’s manufacturing activities. The R&D group applies their vast experience and knowledge of Corynebacterium glutamicum, to develop new uses for C. glutamicum in biopharma production. Corynex®, a protein expression system, is an example of this. It simplifies the purification process of complex recombinant proteins and improves your drug development process. Currently, the R&D group is working on using C. glutamicum for a novel RNA producing system for the bio-production of various types of long chain RNA (> 100 mer) with high scalability and yield.
For large scale oligonucleotides, Phosphorodiamidate Morpholino Oligomers (PMO) and peptide synthesis, they have developed AJIPHASE®, a hybrid of solid and solution phase syntheses. This advanced technology allows Ajinomoto Bio-Pharma Services to manufacture large commercial quantities of various oligonucleotides under GMP in a cost effective way. Finally, AJICAP™ is a site-specific conjugation technology for intact native antibodies used for the ADC development for novel therapeutics.
How is Ajinomoto Bio-Pharma Services positioning itself for the future?
JBA: Looking to the future, we are investing in several projects to expand our service offerings and capabilities. We are adding a nested flexible fill line that will support a broad range of drug substance APIs, increasing capacity by 50%, enabling larger batch size and a broader range of aseptic filling volumes for vials, syringes and cartridges. We have added automated packaging and labeling equipment, offering serialization and aggregation capabilities to support and comply with Drug Supply Chain Security Act. We have also reconfigured GMP small molecule manufacturing suites to support increased HPAPI capacity and improve process safety with additional instrumentation. Last year, we opened a 2,000 m2 large scale oligonucleotide API manufacturing facility, in order the better serve the increasing demand of the oligonucleotides market. Most recently, we completed the acquisition of our small molecule API manufacturing joint venture in India. Individually and together, these investments strengthen Aji Bio-Pharma’s commitment to providing its clients accessibility to a reliable and simplified CDMO supply chain, while bolstering our CDMO offerings.