Hospira offers a full range of services to provide clients with a competitive edge.
Innovation and drive fuel the research and development (R&D) team and provide the foundation of Hospira's analytical services. Scientists develop analytical and manufacturing methods to match product needs, and conduct product feasibility studies that identify sound commercialization options. Experienced and highly dedicated, the R&D team develops solutions to meet clients' product delivery goals.
One 2 One's formulation/analytical development scientists are experts in the following areas:
- Biomolecule and small molecule parenteral product formulation
- Solutions, including lyophilized and dispersed systems
- The development and validation of analytical methods to meet regulatory requirements
- Analytical capabilities, which include freeze-dry microscopy, UV spectrophotometry and protein assay methods and high pressure liquid chromatography (HPLC) methods
The One 2 One team uses proven processes and a comprehensive strategy to deliver quality parenteral products to global markets. Utilizing resources in Lake Forest, Ill., USA, and Liscate, Italy, One 2 One can provide clients with product development, technology transfer, fill and finish, product release, supply chain management and regulatory filing strategies for North America, Europe and Japan.
To package your product on-site at a One 2 One facility, we offer diluents in vials, amps and prefilled syringes (private or custom label); single-printed cartons; bulk packaging; blister trays; product inserts and labeling.
The Global Regulatory Affairs team provides comprehensive support for each product throughout domestic and international registrations processes. This team provides comprehensive assistance for both the review and approval phases, and, after approval, works with the client to submit post-approval changes to the Food and Drug Administration (FDA) and other regulatory agencies. Hospira focuses on shortening timelines for regulatory approvals, using electronic submissions to advance commercialization efforts and Chemistry Manufacturing and Controls (CMC) support.