One 2 One^® - Custom Ph II/III Development and Contract Manufacturing of Parenteral Products

Hospira is a global speciality pharmaceutical and medication delivery company dedicated to developing, manufacturing and marketing products that help improve the productivity, safety and efficacy of patient care. The company’s One 2 One® business is a world leader in the custom development and manufacture of parenteral products packaged in vials, prefilled syringes, cartridges, flexible containers and ampuls. One 2 One offers parenteral development and manufacturing services at its nine worldwide facilities.

Extensive parenteral development and contract manufacturing experience

Hospira has over 80 years of know-how in parenteral drug commercialization, and One 2 One has over 20 years of experience serving the global pharmaceutical and biotech industry. In that time, we’ve successfully produced and launched many parenteral products for our partners, including 16 commercialized biologics. Whether your product is a small molecule or advanced biologic, our highly qualified personnel in every world-class facility ensures our partners' quality, capacity and security of supply.

Parenteral products for global markets

The One 2 One team uses proven processes and a comprehensive strategy to deliver quality parenteral products to global markets. Utilizing resources in our global locations, 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, Asia and Australia.

Research and development, validation and regulatory submission preparation

Hospira's product development provides a distinguished network of experienced scientists, regulatory experts and industry decision makers. These resources provide support throughout the latter stages of the development process as well as guidance on drug delivery systems designed to enhance existing product offerings. One 2 One offers a full range of services for product development, including ImpurID™ services, process development, ICH stability programs, production scale-up, validation and regulatory submission preparation.

Parenteral manufacturing facilities

One 2 One has nine parenteral manufacturing facilities in North America, Europe and the Asia Pacific region, each registered with multiple regulatory agencies worldwide:

• Austin, Texas, USA: flexible container expertise
• Boulder, Colorado, USA: high potency API manufacturing
• Clayton, North Carolina, USA: emulsions expertise
• Lake Forest, Illinois, USA: Hospira product development
• Liscate (Milan), Italy: development and manufacturing excellence
• McPherson, Kansas, USA: a leader in biologics fill/finish
• Mulgrave (Melbourne), Australia: cytotoxics expertise
• Rocky Mount, North Carolina, USA: versatility and packaging solutions
• Wasserburg, Germany: lyophilization expertise

Customized commercialization of parenteral drug products

One 2 One offers seamless coordination through a globally centralized management team, and manufacturing scale and capacity to accommodate broad-scale, customized commercialization of your parenteral drug product:

• Biologics (monoclonal antibodies, proteins, peptides and recombinant vaccines)
• Potent and cytotoxic drugs
• Emulsions
• Lyophilization
• Syringe and cartridge filling
• Infusion drug delivery systems
• Multilingual packaging and labeling
• Supply/cold chain management