Dive Brief:
- Recently-established biomanufacturing company Wheeler Bio broke ground on an Oklahoma City facility that will offer small-batch production of clinical trial drugs to developers, the company announced Thursday.
- The 35,000-square-foot facility, engineered and built by construction firm CRB, includes a sterile cleanroom featuring a “ballroom” open design with no fixed equipment and minimal segregation of processes due to closed systems. Wheeler Bio claims the open cleanroom layout will provide needed agility to better serve early clinical phase developers.
- Construction on the facility was supported by a series funding round and it is slated to be completed by 2023.
Dive Insight:
One of the drugs the Wheeler Bio facility will focus on is recombinant proteins, a type of monoclonal antibodies, which are lab-made proteins designed to fight a particular infection.
The contract drug manufacturer embarks on biologics production just as the monoclonal antibodies market is experiencing explosive growth, according to a study in the Journal of Biomedical Science. In addition to recombinant proteins, the drug contract manufacturer will also make antibodies.
“As the prominence of biologics grows in the global fight against viruses and disease, we’re honored to work alongside Wheeler in providing flexible spaces that can support the continued evolution of this important work,” Market Team Leader at CRB Ashley Reynolds said in a statement.
The biomanufacturer is new to the market, formed through a partnership between Alloy Therapeutics and Echo Investment Capital.
Wheeler’s facility will leverage Industry 4.0 and lean manufacturing practices for more efficient and scalable production. The site will feature cell banking, on-site quality control labs, development labs and integrated digital systems to streamline operations, according to its website.
Wheeler will also employ Good Manufacturing Practices enforced by the FDA to ensure products are consistently produced and controlled according to quality standards.
“This design gives us the ultimate flexibility in manufacturing operations while maintaining quality and regulatory compliance,” Yuk Chun Chiu, CMO of Wheeler, said in a statement.
