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Prompt Access to Contract Lyophilization and Sterile Pharmaceutical Manufacturing Offered - LyoTechnica, LLC announced today that it has established relationships with multiple parenteral contract manufacturing firms as a means to help speed the development of its clients’ injectable products
Prompt Access to Contract Lyophilization and Sterile Pharmaceutical Manufacturing Offered

 

PRZOOM - /newswire/ - Cleveland, OH, United States, 2010/08/31 - LyoTechnica, LLC announced today that it has established relationships with multiple parenteral contract manufacturing firms as a means to help speed the development of its clients’ injectable products.

   
 
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“LyoTechnica supports the activities necessary to file INDs, NDAs or ANDAs,” said Glenn Wickes, Jr., president of LyoTechnica. “With the establishment of our network of parenteral contract manufacturers, we are now able to help our clients by recommending the best fit for their contract manufacturing project, whether it be large or small, requiring lyophilization or not.”

LyoTechnica provides a wide range of contract pharmaceutical development services 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. The company offers development through commercial manufacturing of parenterals at the same site. Lyophilization capacity is up to 19,000 10 ml vials per batch.

LyoTechnica, LLC (lyotechnica.com) 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).

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.

LyoTechnica, LLC is headquartered at 4747 Beachwood Court, Carlsbad, CA 92008. T: 877-792-3737, F: 760-729-3736, E: info[.]lyotechnica.com.

 
 
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Prompt Access to Contract Lyophilization and Sterile Pharmaceutical Manufacturing Offered

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