Capua BioServices (“Capua”) has been executing fermentation processes for over 50 years, and, thanks to our highly experienced staff, the company has been able to develop into a contract development and manufacturing organization (CDMO) with a strong reputation that enables the rapid development and scale-up of optimized manufacturing solutions.
Adding Value to Strategic Partnerships
While all CDMO projects flow from technology transfer through scale-up, at Capua we recognize that true value is added by developing a tailored process designed to fit the specific needs of each client, and creating customized solutions within a standard framework maximizes the likelihood of success. The use of a matrix approach involving effective internal collaborations within multidisciplinary teams is another way that Capua benefits our customers.
People and Expertise
Over many years, our experienced staff have gained an invaluable breadth and depth of knowledge that is applied to each new project. Our average company seniority is currently 15 years. Gerald Hofmann (Head of the Technology Development department) joined Capua in 2010, bringing extensive experience in fermentation process technology and optimization. Stefano La Porta (Senior Process Feasibility & Quotation Expert) joined Capua in 2012; he has over 17 years of experience in scientific research and microbiology and biological process improvement and represents a turning point when it comes to fitting and scaling new processes into our facility. Luigi Attaianese (Head of Technical Site Services, HSE and Security departments) joined Capua in 2011. He brings 32 years of experience in engineering in HSE and plays a key role in ongoing expansion projects.
Building strategic partnerships is all about dedicating people to work together, so that all available expertise is accessible for a project’s success. Within Capua, we have the experts to orchestrate and manage complex and highly demanding procedures while maintaining the flexibility to react specifically to the dynamics of the individual project. The project and business managers are key; Capua experts work directly with clients to facilitate progress. The project flow, communication frequency and overall approach are adjusted to meet the specific needs of each client.
Investing in Partnerships
Since 2015, we have run both operational and capital expenditure programs for Capua’s dedicated pharma-grade and food-grade facilities to increase capacity and flexibility. To further broaden our service spectrum, Capua invested in a new spray-drying capacity in 2017 and opened a dedicated process development laboratory in early 2018; we will continue to add new development equipment in the future. As part of an exciting new strategic partnership, we are revamping existing fermentation capacity and constructing a client-dedicated downstream processing (DSP) facility that will be launched in October 2018.
Case Study: Collaboration for Acceleration
To meet the urgent need for a cost-effective second supplier of an existing product, Capua designed a dedicated onboarding program that includes early and direct involvement of the technology, manufacturing and supply chain departments; a joint, continuous improvement program; and transparent and frequent communication. Technology transfer was completed and the first commercially viable products sold in the market within three months. After two years, the yield per batch was improved by 220% and overall capacity by more than 300%, with the overall cost of goods and quality exceeding the joint set targets. Capua continues to invest in our people, processes and facilities to continuously create growth opportunities.
An early-stage client — in urgent need of a knowledgeable CDMO — selected Capua to implement a joint fast-track development program with the potential to build a long-term strategic relationship. Although no clear decision had been made on technology and development scope, project kickoff, technology transfer and the first significant process development milestones (including scope changes) were completed within six months. A process for the sustainable manufacture of first batches was ready after one year, with further optimization underway and scale-up expected within the next 6–12 months.
At Capua, our focus is on bringing in the right people, with the right expertise, together at the right times — all the while working closely with our clients. This allows us to jointly focus on what is needed by whom, and by when, in order to create truly shared success.