The development of microbial fermentation processes for the production of pharmaceutical APIs can be challenging. Experience, flexibility, change-management skills and tailored support are essential for CDMOs wishing to effectively support their clients.
Challenging Timelines and More
Microbial expression using bacteria, yeast or fungi is often preferred over cell culture for the production of smaller biologics (including peptides, proteins, cytokines, growth factors, plasmid DNA, single-domain antibodies, peptibodies and antibody fragments), because the process times are typically much shorter and media costs can be lower.
Microbial fermentation process development for pharmaceutical API production can be challenging. Even with their shorter process times, development timelines can be challenging, particularly when combined with restricted budgets. As with all development projects, both anticipated and unexpected issues can arise that require process changes. Those changes must be effectively managed throughout the project, which requires both flexibility and an appropriate change-management strategy.
Becoming the Microbial CDMO
Capua BioServices, which solely focuses on microbial fermentation, was acquired on January 25th, 2019 by Olon S.p.A., an Italian company and leader in the production of APIs via synthesis and biological processes for pharma outsourcing needs. Together, both entities now offer an impressive total fermentation capacity of 4500 m3, which is available for microbial CDMO services. As a result of the integration, Capua and Olon’s unique joint offering now also includes access to Olon’s research and development capabilities, strain construction and improvement, as well as highly potent API (HPAPI) fermentation capabilities.
Experience and Flexibility Are Key
Both Capua BioServices and Olon have extensive expertise using microbes, such as — but not limited to — Escherichia coli, Staphylococcus aureus, Streptomyces spp., Aspergillus spp. and Pichia pastoris, for the production of small molecule antibiotics, enzymes and proteins for pharmaceutical applications.
Our joint technology teams are dedicated to bringing new projects on board and includes both upstream and downstream experts. Each team member has worked at the company for many years on a variety of processes and applies that experience to the development of solutions for each new project. They also have experience working with large and small clients and understand the different needs of companies with projects at different stages of development. This experience is supported by the highly flexible design of our process development lab, pilot plant and commercial manufacturing units, which presents opportunities for implementing different processes and different types of unit operations. It is also possible to run multiple processes in parallel; even if significant process changes are required, there is a high likelihood that the revised process can be performed within our existing infrastructure.
Our joint flexibility also extends to the way we onboard projects; especially with two fermentation sites now available. While we follow a typical baseline flow (tech transfer to development to scale-up to piloting), we can tailor each development program to meet the specific needs of our customers. Creating customized solutions within a standard framework maximizes the likelihood of success and creates real value for our clients.
Creating customized solutions within a standard framework maximizes the likelihood of success and creates real value for our clients.
Experience and flexibility are supported by up-front alignment of Capua BioServices and Olon with each client. Establishing good relationships and clear and transparent communication is an essential component of our development strategy. We jointly agree on the definition for change in scope and targets, expectations and a path forward that everyone is committed to. All of these factors contribute to our ability to successfully establish long-term strategic partnerships. Our highly experienced and dedicated employees make all of these efforts possible.
Comprehensive Approach to Microbial Process Development
Four key components contribute to successful microbial process development at Capua BioServices and Olon (“All in One”): our people; our capabilities; our flexible equipment, technology and mindset; and our ability to manage scope changes. We have the right balance between flexibility and control, which enables us to foster fruitful collaboration and problem solving tailored to each client project.