Virotherapy manufacturing facility
Boston, Massachusetts, US
Phase one: December 2021
Vibalogics/Ampersand Capital Partners
German biotechnology firm Vibalogics announced the development of a late-phase clinical and commercial virotherapy manufacturing facility in Boston, Massachusetts, in November 2020.
The facility is intended to improve the company’s capabilities to meet the rising demand for the development and manufacturing of complex viral-based products, expanding the company’s global footprint.
Vibalogics was acquired by Ampersand Capital Partners, a private equity company, in May 2019. The estimated investment in the development of the facility is approximately $150m, which will generate up to 350 jobs.
The company completed the first phase of the plant’s construction in December 2021. Construction of further good manufacturing practice (GMP) capacity in phases two and three is scheduled for 2022 and 2023.
Vibalogics’ virotherapy manufacturing facility location
The late-phase and commercial viral vector manufacturing facility is being developed within a 145-acre campus at 1414 Massachusetts Avenue, Boxborough, in Massachusetts, located around 40km from Boston.
Boston was chosen as a preferable option for the facility due to its access to the life sciences and economic cluster around Greater Boston and was suitable for the plant’s unique requirements.
Several world-renowned universities, including Harvard, MIT, Yale, Boston College, Wellesley, Boston University and Worcester Polytech, are also close to Boston.
Vibalogics’ virotherapy manufacturing facility details
The 118,000ft² (10,962m²) manufacturing facility, with 30ft clear space, features state-of-the-art technology. It is designed for manufacturing commercial quantities of viral vectors such as oncolytic viruses and viral vector vaccines.
The facility is equipped with a 2×2,000l single-use bioreactor train to enable the production of millions of vaccine doses, as well as additional aseptic fill-finish capabilities.
It will be used to support the manufacturing of respiratory syncytial virus (RSV), dengue and HIV vaccines, as well as Covid-19 vaccines.
The addition of a late-stage clinical and commercial facility will allow Vibalogics to easily transfer the technology for its customers’ products from its early-stage production facility in Germany to the US, providing comprehensive end-to-end solutions from pre-clinical to commercial manufacturing.
The facility will improve the company’s capabilities to meet the rising demand for the development and manufacturing of complex viral-based products, expanding the company’s global footprint.
Virotherapy manufacturing by Vibalogics
Virotherapy production is a complex, multi-stage process. The company utilises its more than 15 years of experience with live viruses, such as herpes virus (HSV), adeno associated virus (AAV) and cytomegalovirus (CMV), for manufacturing.
The company produces viruses in various culture vessels, including shake flasks, single-use suspension bioreactors, disposable iCELLis® fixed-bed bioreactors, T-flasks, roller bottles and CellSTACK®, catering to its customers’ diverse virotherapy product requirements.
Vibalogics develops and manufactures both cell-based (suspension and adherent) and egg-based viruses. It offers full upstream and downstream processing, analytical testing (including method transfer, development and validation), and filling/finishing services, with a focus on the manufacturing of virotherapy.
With a unique emphasis on viruses, live bacteria and aseptic manufacturing, the company’s 50 workers operate in strict compliance with international GMP requirements at its state-of-the-art BSL-2, 27,000ft2 (2,500m2) plant in Cuxhaven, Germany.
Vibalogics’ Covid-19 support
Vibalogics collaborated with Janssen, a subsidiary of Johnson and Johnson, to provide additional clinical trial material for the lead Covid-19 vaccine candidate being developed by Janssen.
Janssen produces several batches of material in its GMP facility in Cuxhaven, Germany, to produce thousands of doses of a Covid-19 investigational vaccine candidate.
The facility was equipped with new equipment, including a new filling line capable of filling and labelling more than 30,000 vials for each batch to handle larger clinical batches.
The collaboration is intended to boost Vibalogics’ position in the development of virotherapy worldwide while providing crucial service to its customers to combat SARS-CoV-2 virus.
Contractors involved in the project
Global commercial real estate services company Colliers International acted as advisor to Vibalogics for the long-term lease transaction of the property for the new facility.
Lincoln Property Company, the property’s building owner, also worked with Vibalogics to close the deal.
Cardinal Group USA was contracted to provide project management, including demolition and construction. DPS Engineering, a project management, consulting and engineering company, was contracted to provide consulting and design services for process development and quality control laboratories at the facility.
Germfree Laboratories, a modular cleanroom supplier based in Florida, built the facility’s BSL-2 GMP-compliant production environment.