Dalton Pharma Services will take responsibility for GMP preparation and filling into glass vials of Arch Biopartners’ AB569 bactericidal inhalation solution for an upcoming Phase 1 trial, the companies have announced. Dalton will provide a range of services, including formulation development, method development and validation, and quality control release testing in addition to filling.
Arch had previously announced that it had selected Catalent Inhalation for manufacturing of clinical trial supplies of AB569; the company now says that Catalent has completed early formulation and stability studies and will be involved with the final testing after Dalton fills the vials.
Dalton President and CEO Peter Pekos commented, “Dalton is privileged to be supporting this critical GMP campaign, and to play an important role in the development of this innovative antibiotic for the treatment of lung infections that affect millions of patients. The need for a new, effective treatment is very great; some pulmonary bacterial infections are resistant to all 26 antibiotics approved in the United States.”
Read the Arch Biopartners press release.
Read the Dalton Pharma Services press release.