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Active Pharmaceuticals Ingredients
SPL offers a broad spectrum of technology capabilities in support of development and manufacturing services for the extraction, isolation and purification of naturally-derived materials and fermentation, isolation and recovery of therapeutic proteins. These services range from preclinical and clinical supplies in cGMP compliant suites through commercial scale-up of APIs. Manufacturing services can be carried out in either existing facilities or possibly through leveraging our existing infrastructure via expanded capital additions when required.

Full analytical, validation and regulatory filing support assures that the API manufacturing component of a development project need not be a roadblock on a project's critical path. In collaboration with our customers, successful application of this approach reduces risk, enabling customers to deploy their scarce resources on the things that are most important in getting their products to market. All services operate within cGMP compliant facilities with stellar regulatory records, available upon request.

General Capabilities include:

 
Variety of processing techniques to prepare target products for initial evaluation
Optimization and validation of best processes for manufacture of target product(s)
Development and validation of analytical methods for in-process control and product release
Completion of product stability studies under ICH guidelines to establish shelf-life parameters
Scale-up to full commercial production
Complete regulatory support
 
     
  Specialty Capabilities:  
 
Fermentation
Natural Products Extractions
Heparin Derivatives
Recovery & Purification
Analytical Support
 
     
Active Pharmaceutical Ingredients
Contract Services and Capabilities
Fermentation
Natural Product Extractions
Heparin Derivatives
Recovery and Purification
Analytical Support
Regulatory Support
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