On May 19, 2023, Krystal Biotech, a client of Berkshire Sterile Manufacturing (BSM), received FDA approval for VYJUVEK™, the first-ever topical gene therapy approved to treat dystrophic epidermolysis bullosa (DEB) in children and adults six months of age or older. BSM supplies an excipient gel, a key component of this new and innovative therapy. VYJUVEK is the first and only FDA approved treatment for DEB and is designed to address the underlying genetic cause of the disease. Berkshire Sterile Manufacturing manufactures an excipient gel that forms a component of the product, which is applied topically to open wounds on the skin.
DEB is a rare and painful skin condition that presents as extremely fragile skin that blisters and tears with minor friction or trauma, such as rubbing or scratching. This is caused by mutations in the COL7A1 gene, resulting in the lack of functional type VII collagen, which disrupts the formation of anchoring fibrils in the skin and prevents the adhesion of the epidermis to the dermis. The condition is often inherited or a result of a genetic mutation and presents in infanthood. Fewer than one in 20,000 children are affected, and these patients are often called “butterfly children” because their skin is as fragile as a butterfly’s wings. In severe cases, patients become covered in painful sores that are difficult to heal on their own and can lead to vision loss, disfigurement, and other serious and sometimes fatal medical complications.
“Being part of this FDA-approved project fills me with pride,” said BSM Project Manager, Lynne Anstett. “It’s incredibly humbling to see how our team’s hard work is paying off and the impact it will have on people’s lives. This achievement really motivates us to keep pushing boundaries and coming up with innovative solutions.”
“This approval is a testament to BSM’s unwavering commitment to quality and upholding cGMP guidelines,” BSM Vice President of Quality Assurance, Debbie Smith, commented. “We are motivated to deliver these treatments to our clients and their patients, and that means meeting the most stringent quality standards throughout the manufacturing process.”
About Berkshire Sterile Manufacturing:
Berkshire Sterile is a state-of-the-art fill finish contract manufacturer that is specialized in sterile filling of vials, syringes, and cartridges for biotech and pharmaceutical industries. BSM also offers terminal steam sterilization, specialty filling, and lyophilization of vials all within isolators. Analytical support, stability studies, 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.
Read the full article: FDA Approves Groundbreaking New Product Utilizing Berkshire Sterile Excipient Gel to Treat ‘Butterfly Children’