Development and Manufacturing Services

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 development and production of preclinical and clinical supplies through commercial scale-up of APIs. Manufacturing services can be carried out in either existing facilities or possibly through leveraging our existing infrastructure via capacity expansion 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 things that are most important in getting their products to market. All services operate within cGMP compliant facilities.

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