Dalton Announces a Drug Development and GMP Manufacturing Services Agreement with Arch Biopartners
Dalton Pharma Services, a leading pharmaceutical cGMP contract manufacturing company, today announced the signing of a drug development and manufacturing services agreement with Arch Biopartners, Inc., a Canadian biotechnology firm focused on the development of technologies that have the potential to make a significant medical or commercial impact.
In support of Arch Biopartners’ GMP manufacturing campaign for AB569, the company’s inhalation drug candidate for treating antibiotic-resistant bacterial infections in the lungs, Dalton will provide formulation development, cGMP powder and liquid filling, analytical method development and validation, and quality control release testing.
Dalton will be responsible for the GMP preparation and filling of AB569 into glass vials which will form part of the clinical kits required to support the phase I safety trial for AB569 at the Cincinnati Veterans Affairs Medical Center later this year.
AB569 is an innovative drug candidate for antibiotic-resistant bacterial lung infections, which frequently afflict patients with chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF). COPD is a major health problem worldwide (over 325 million patients) and is ranked by the World Health Organization as the third leading cause of death.
Arch Biopartners has received orphan drug designation for AB569 from the U.S. Food and Drug Administration for treatment of CF patients with Pseudomonas aeruginosa infections, and an orphan medicinal product designation from the European Medicines Agency for the treatment of CF patients.
“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,” said Peter Pekos, CEO and President, Dalton Pharma Services. “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.”
About Arch Biopartners:
Arch Biopartners Inc. is focused on the development of innovative technologies that have the potential to make a significant medical or commercial impact. Arch works closely with the scientific community, universities and research institutions to advance and build the value of select preclinical technologies, develop the most promising intellectual property, and create value for its investors. Arch has established a diverse portfolio that includes AB569, a potential new treatment for antibiotic resistant bacterial infections; Metablok, a potential treatment for inflammation, sepsis and cancer metastasis; MetaMx, which targets elusive brain tumor initiating cells; and, ‘Borg’ peptide coatings that increase corrosion resistance and decrease biofilm on various medical grade metals and plastics. For more information on Arch Biopartners, please visit http://www.archbiopartners.com
About Dalton:
Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a Health Canada approved and FDA registered cGMP contract service provider of integrated chemistry, drug development and manufacturing services to the pharmaceutical and biotechnology industries. We bring 30 years of experience to our client's projects and emphasize quality, speed and flexibility.
Dalton can accelerate your drug development program by integrating process development, cGMP API manufacturing, and sterile or solid finished dose manufacturing, all at a single location. For our full range of in-house services including cGMP sterile fill/finish services please visit https://www.dalton.com.
Our CMO 2016 and 2017 Leadership Awards in the categories of Quality, Reliability, Capabilities, Expertise, Compatibility and Development from Life Science Leader reflect our ongoing commitment to our clients, peers and the business community. In 2016 Dalton was certified as A Great Place to Work.