Why our steriles commercial manufacturing solutions will optimize chances of approval.

Scaling to commercial manufacturing can be arduous as you try to balance speed, regulatory, quality, and your supply chain. We understand that each large molecule and project is unique and has its own set of challenges and needs. Our broad range of manufacturing solutions will adapt to the needs and challenges of your large molecule, while being backed by a global network and industry experts.

Our sterile capabilities also include process development and manufacturing of biologic drug substances at scales from clinical to global commercial. With Thermo Fisher Scientific as your single-source partner, you’ll be able to bring your discoveries to market with speed and efficiency. We also offer disposable (single-use) manufacturing technologies as well as traditional stainless steel equipment. The following state-of-the-art commercial-scale cGMP manufacturing solutions fit into any phase:

Sterile Injectables

Liquid-Filled Vials
  • Aseptic Filling, Terminal Sterilization when required.
  • Extensive range of vial sizes, including ISO standards.
  • Batch sizes to meet product demand.
  • Disposable (single-use system) manufacturing options.
  • Glass or polymeric vials available.
Lyophilized Vials
  • World-class scientific expertise to develop and optimize lyophilization cycles.
  • Disposable (single-use system) manufacturing options.
  • Extensive range of vial sizes, including ISO standards.
  • 750 m2+ of global lyo capacity.
Prefilled Syringes and Cartridges
  • Aseptic Filling, Terminal Sterilization when required.
  • Broad range of sizes and configurations.
  • Disposable (single-use system manufacturing options).
  • Small and large batch sizes available.
  • Glass or polymeric options available.
Sterile Injectables Clinical Services
  • PFS plunger and backstop assembly
  • Needle safety device assembly
  • Auto-injector assembly
  • PFS and reference material binding
Biologic and Sensitive Molecules
  • Peristaltic pumps
  • Controlled-temperature mixing
  • Controlled-termperature filling
  • Cold chain storage and distribution
  • Assembly, packaging, and labeling at 2 C – 8 C
  • Filling under nitrogen

Short-term strategic investment for long-term cost savings

Whether it’s for scaling-up or moving to another facility, technology transfers are part of the normal course of business. In 2019, we successfully completed 119 technology transfers—44 commercial, 60 drug substance, and 15 development. Our dedicated global experts ensure:

Visibility and collaboration across your product’s lifecycle

From development to launch, pharma products navigate a dynamic global supply chain with potential changes and delays. To manage these changes, pharmaceutical companies go to great lengths to understand the status of production, mitigate risk, and proactively forecast. With integrated data sources, smart analytics, and a collaboration-first approach, mysupply Platform drives attention to where it matters most.

Assurance and simpler logistics in your supply chains

Our breadth and depth of capabilities for commercial packaging are designed to accommodate both small and large volumes to ensure that your product can be packaged in the most cost effective way possible. Commercial packaging can help:

Optimize your chances for approval

Thermo Fisher Scientific offers experience, reliability, and a very broad range of fill/finish commercial capabilities. We have an enviable record of steriles commercialization success for our clients.

Leveraging our commercial production and clinical trials solutions will give you extensive access to global technical experts, te, capability, global regulatory insights, and transportation. Global network and solutions span across:

mysupply Platform

An end-to-end digital supply chain platform that provides visibility and collaboration across the full product lifecycle

From development to launch, pharma products navigate a dynamic global supply chain with potential changes and delays. To manage these changes, pharmaceutical companies go to great lengths to understand the status of production, mitigate risk, and proactively forecast. With integrated data sources, smart analytics, and a collaboration-first approach, mysupply Platform drives attention to where it matters most.

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