On September 21st, 2022, Berkshire Sterile Manufacturing’s (BSM) client, Fennec Pharmaceuticals Inc., received FDA approval of their drug product, PEDMARK – a sodium thiosulfate Injection with an indication to reduce the risk of ototoxicity (hearing loss) associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors. The drug is the third product manufactured at BSM to receive FDA approval for commercial use.
“It has been an honor to work on this project for the past two years,” said BSM Project Manager, Alicia Rossie. “I have learned a lot working with the Fennec team throughout the process, and it is particularly gratifying to know that their product could help improve the lives of children.”
Fennec’s PEDMARK injection is the first and only FDA-approved therapy indicated to reduce the risk of ototoxicity – hearing loss caused by a medicine – associated with cisplatin, a common chemotherapy drug in children’s cancers. The injection is indicated for pediatric patients over a month old with localized, non-metastatic solid tumors. BSM fills the medication into 100R vials on their semi-automated, isolator-based filling line.
“We are thrilled for our client, and we are honored to be a part of their success story,” said cofounder and Chief Technical Officer, Dr. Andrea Wagner. “We manufacture several unique medicines and treatments. PEDMARK is no different. Our team understands the good that come from these drugs we manufacture and their value to the patients taking them. That is why we put so much effort into ensuring our clients get the highest-quality product achievable.”
Fennec resubmitted a New Drug Application (NDA) to the FDA for PEDMARK in March of 2022, and the FDA conducted a Pre-Approval Inspection (PAI) at BSM in Lee, MA in May of 2022. The inspection concluded with no observations related to Fennec’s product.
BSM Vice President of Quality Assurance, Debbie Smith, commented, “This approval shows BSM’s continued dedication to complying with cGMP guidelines. We have once again demonstrated our commitment and ability to meet the highest quality standards in the manufacturing of our clients’ products.”
“BSM’s continuous support and commitment to quality were instrumental as part of Fennec’s NDA approval of PEDMARK”, said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “We look forward to a long and productive relationship with BSM.”
BSM performs formulation, formulation development, sterile filling of vials, syringes, and cartridges, lyophilization, analytical development, and validation as well as a full-service array of analytical and micro-offerings. BSM quickly expanded from three cofounders in 2014 to 215+ employees today to meet demand. Berkshire Sterile invests in state-of-the-art, isolator technology to enhance the sterility and quality of the drug products it produces, and they recently installed a third isolator line to increase their capacity to 90,000 unit lots with commercial capabilities for lyophilization as well.
About Berkshire Sterile Manufacturing
Berkshire Sterile is a state-of-the-art fill/finish contract manufacturer which specializes in sterile filling of syringes, vials, and cartridges for biotech and pharmaceutical industries. BSM also offers terminal steam sterilization of syringes, specialty filling, and lyophilization of vials all within an isolator. Lyophilization development, formulation development, and method development are also offered. For more information, please visit the company’s website (https://berkshiresterilemanufacturing.com/) or contact them at firstname.lastname@example.org.
About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® for the prevention of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK received FDA approval in September 2022 and has received Orphan Drug Designation in the U.S. Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans. For more information, please visit www.fennecpharma.com.
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