«CMC Program Health» Assessment

Through a board member recommendation, Cilatus was asked by the CEO of a late-stage, US West Coast based, publicly listed Biopharmaceutical Company to assess the «CMC program health» of their phase III, small molecule development candidate. Within one month, the Cilatus team was able to assess all CMC areas of the late-stage program: the drug […]

«Virtual CMC» Development

For one of our first clients, Cilatus performed as the external, «Virtual CMC» development, CMC regulatory affairs and quality assurance team. Our US-based, NASDAQ listed client didn’t have any of these functions internally because they wanted to stay lean and wanted to stay focused on their science and clinical development. Therefore, Cilatus carried out all […]

Conceptual Development of Biologic Manufacturing Campus

Most of our clients work with CDMO’s and CMO’s in the early development stages. As one Biologic client progressed into late-stage development and potential market approval, they were eager to know how much would it take and how long would it take to develop their own manufacturing facility. Cilatus analyzed the predicted market demand of […]

Process Characterization and Validation

On recommendation, Cilatus was asked by a Chinese biopharmaceutical company to support their process characterization and validation effort. Cilatus analyzed all development work done to date, carried out a comparability assessment to the reference medicinal product, and then developed a customized, multi-layer process characterization and validation framework and work plan for the client. The assignment […]

Due Diligence for Investors

A few years ago, Cilatus was asked to perform CMC due diligence for two private equity investment companies who wanted to invest in a novel biologic for an unmet medical need that was being developed by a small European biopharmaceutical company. Cilatus initiated the due diligence effort with a visit to the biotech company and […]

EU Regulatory Lead, US Client

Cilatus Regulatory was selected by a US biopharmaceutical company to provide strategic and operational EU regulatory leadership to support the commercial launch and lifecycle management of two orphan drugs. Cilatus co-ordinated and managed regulatory activities, submissions and information requests with EU national affiliate offices. Cilatus managed regulatory aspects of artwork and labelling including the introduction […]

Authoring of IND Module 3, US Client

US based biopharmaceutical company engaged Cilatus Regulatory to author the Phase 1 IND Module 3 for a recombinant protein. Working to tight timelines, Cilatus took source documents and authored the IND Module 3. Cilatus integrated with the company Technical Operations team to author sections as data and information became available. Cilatus led and managed multiple […]

Quality Management Systems «Gap Assessment» and Remediation

The CEO of a San Francisco Bay area, clinical-stage biotech company asked Cilatus to provide strategic and operational Quality Assurance Leadership to ensure that their Quality Management System (QMS) was fit for purpose for the clinical-stage to which the company’s lead asset had progressed to. An initial «Gap Assessment» and diagnostic of existing QMS elements […]

QP Release, Auditing and QP Certification, US Client

Cilatus Manufacturing Services was selected by a Boston-based, US Biopharmaceutical Company to provide QP Release and QP Certification services for their clinical-stage lead asset. Cilatus completed all QP Audits of all manufacturing, testing and packaging sites within the supply chain of this small molecule asset. Then Cilatus provided the QP Declarations, which are required for […]

Auditing, QP Release, and QP Certification, Chinese Client

Based on an ongoing consulting engagement by Cilatus BioPharma Consulting, Cilatus Manufacturing Services was approached by a Chinese Biopharmaceutical Company to provide QP Release and QP Certification services for a biologic investigational product for a European Union clinical trial. Cilatus mapped the entire clinical supply chain with the Chinese client and also recommended a path […]