Injectable drugs development and manufacturing

Injectable drugs development and manufacturing

We guide a worldwide portfolio of customers through the formulation and analytical development, manufacturing, sterile fill-finish, packaging and labeling of injectable drug products to GMP standards.

A dedicated and integrated partner for your journey

Fully integrated sterile fill-finish capabilities for the development and production of small and large molecule injectable formulations including peptides, oligonucleotides (DNA, recombinant RNA, synthetic RNA, RNA vaccines) and proteins.

Our integrated platform is uniquely built to support and enable your early phase injectables development through clinical studies and into small-scale commercialization.

We use a dossier-oriented approach paired with long-standing regulatory knowledge to ensure we use the right standards at the right development phase to support successful regulatory filings.

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Sterile Fill & Finish Services

Sterile Fill & Finish Services
  • Sterile drug products – aseptically prepared
  • Liquid formulations in vials
  • Wide range of molecules:
    • Small molecules (including peptides)
    • Nanomedicines
    • Biotechnology products (e.g. recombinant proteins, monoclonal antibodies)
  • Small to medium scale batch sizes
  • Clinical trial material (IMP)

State-of-the-art Aseptic Production Area

State-of-the-art Aseptic Production Area
  • 300 m² production area designed in accordance with EU GMP Annex 1
  • Cleanroom area (Grade C) with a separate weighing room, compounding room and 2 filling rooms
  • Visual inspection room
  • Secondary packaging and labeling room
  • Material and drug product staging area
  • State-of-the-art environmental control and monitoring (EMS)

Filling rooms equipped with closed isolator technology

Filling rooms equipped with closed isolator technology
  • Physical barrier between drug product and environment
  • Integrated EMS
  • Automated VHP decontamination cycle
  • Power supply backup (UPS and EPS)

Related resources

Our expert team members share deep, scientific understanding and insights into injectable drug development and manufacturing.

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On-demand webinar: Compatibility and In-Use Stability Studies for Injectables
Webinars

On-demand webinar: Compatibility and In-Use Stability Studies for Injectables

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# CMC Regulatory Drug Product Injectable Drugs
Fill & Finish Services
Info sheets

Fill & Finish Services

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# Drug Product Injectable Drugs

Your molecule, your journey, our mission.

Get in touch to see how we can craft your path to the clinic with dedicated capabilities.

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Our integrated platforms

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.

Drug substance

Helping you turn your compounds that show promise into GMP-grade drug substances.

Drug product

We advance your clinical candidates through the pipeline quickly and safely with specialist drug product services.

Bioanalysis

Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline preparation and submission of your registration file.

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.

Drug product

We advance your large molecule candidates through the pipeline quickly and safely with specialist drug product services.

Bioanalysis

Our bioanalytical platform supports your large molecule drugs through preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your large molecule drug.

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.

Drug product

We turn your nanomedicine candidates into suitable drugs with specialist development and manufacturing services.

Bioanalysis

Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your nanomedicines.