ACE BioSciences A/S has appointed Dr Roberto Machuca, a virologist with over 13 years R&D experience as Operations Manager.
Dr Machuca will be responsible for the commercial process and manufacture of ACE BioSciences’ growing portfolio of vaccines and antibodies.
In the first instance he will focus on the company’s lead product, ACE393, Vaccine for Travellers’ Diarrhoea (TD) caused by Campylobacter infection, which is in Phase I trials.
Dr Machuca joins ACE BioSciences from Bavarian Nordic A/S where he gained direct experience of selecting and managing contract research organisations (CROs) and GMP contract manufacturing organisations (CMOs) to underpin the clinical development and commercial manufacture of the company’s recombinant vaccine portfolio.
As Director of Technical Assessments at BN, Dr Machuca was responsible for identifying, testing and managing a formulation strategy and taking a new drug candidate through research and preclinical testing into Phase I trials.
He also spearheaded the search for products to add to BN’s pipeline and led the screening and evaluation of new projects.
Prior to that Dr Machuca spent two years as BN’s Manager of Production Support. During this time he established three production programmes, leading the search and selection of external CMOs; negotiating associated agreements and managing CMO performance to ensure the implementation of each production process.
Dr Machuca joined BN as a QAC Scientist, undertaking Quality Assurance, Good Laboratory Practice and GMP work associated with the company’s second generation smallpox vaccine and liaising with QA audit test laboratories and CROs regarding clinical trials.
In this capacity he presented the scientific rationale of BN’s release test programme to the UK authorities.
Dr Mike Darsley, ACE BioSciences’ Chief Development Officer commented, "Dr Machuca has an exemplary skill set and his experience is directly relevant to our activities."
"He joins the company at a pivotal time when our lead product is progressing through clinical trials and the final commercial manufacturing process is being defined and validated."
"We are expanding our vaccine portfolio and our ongoing manufacturing strategy is to continue to identify and work with CMOs during all stages of product development and launch. We are pleased to welcome Dr Machuca to the team."
Prior to BN, Dr Machuca worked for Statens Serum Institut for eight years, undertaking research on retroviruses and HIV. Dr Machuca gained his PhD during his time at the SSI.