LyoTechnica, LLC has announced that it has been established to provide contract drug development services for injectable pharmaceuticals. The company and its affiliates bring over 80 years of combined experience in lyophilization and liquid dosage form development as well as over 100 years experience in commercial scale manufacturing of parenteral drugs. The company offers analytical and formulation development, manufacturing of sterile stability batches and stability testing services.
A wide range of contract pharmaceutical development services is offered for liquid or lyophilized aseptic dosage forms, including high potency and cytotoxic products as well as small molecule or biopharmaceutical products. The company can provide fast turnaround for parenteral development projects, and has created a process to develop and complete a typical lyophilization cycle development project in under sixty (60) working days from receipt of client-supplied materials. If sterile stability batches are required, the total project can be completed in under 90 days, according to the company.
LyoTechnica, LLC also provides regulatory support services, including proven expertise in Electronic Common Technical Development (eCTD) submission services. LyoTechnica's eCTD affiliate has successfully completed 70 eCTD filings and over 300 Electronic Gateway Submission Filings (ESG).
"LyoTechnica was formed to help speed the drug development process for injectable drugs," said Glenn F. Wickes, Jr., President and CEO. "We work with pharmaceutical companies with limited resources as well as larger firms needing additional resources applied quickly to a project. Our framework allows for cost-effective and efficient development."
A complete list of services offered by LyoTechnica, LLC includes process design and development (with container / closure selection, lyophilization development, and lyophilization optimization), global sourcing of APIs, process validation support, design space studies, technology transfer documentation, sourcing of contract parenteral manufacturing, sourcing of qualified contract analytical services, project management, regulatory support services and eCTD submission services.