Clinical-Scale Injectables Manufacturing and Packaging


In the world of CMC development services, there recently have been some notable acquisitions of companies with clinical scale injectables operations. AMRI acquired Oso Biopharmaceuticals in late 2014, and Piramal acquired Coldstream in January 2015. These acquisitions bring strategic synergies that poise both AMRI and Piramal well in a market with significant anticipated growth, which is fueled by ample financial investments received by early stage bio/pharmaceutical companies since 2013.

To learn more about companies that offer clinical dose manufacturing and packaging services, a look into the PharmSource STRATEGIC ADVANTAGE database reveals 205 companies located in 29 countries around the world, with capabilities including:

  • Clinical supplies packaging and services
  • Injectable Phase I/II clinical trials materials (CTM) and formulation
  • Solid, semi-solid/liquid Phase I/II CTM and formulation

For each of the above areas there are sub-categories that enable refined searches based on specific manufacturing and/or packaging needs.

Dataset for Clinical Supplies Packaging and Services

  • Ten criteria specifying different types of clinical supply services including clinical label production, comparator procurement, IVR, overencapsulation/placebo manufacture, warehousing and fulfillment, and other options.
  • Three categories of clinical supplies manufacturing: overencapsulation; capsule placebo manufacture; and tablet placebo manufacture.
  • Two warehouseing and storage options: freezer storage and refrigerator storage.
  • Regulatory approvals and certifications.

Dataset for Injectable Phase I/II CTM and formulation:

  • Development capabilities, including clinical supplies manufacturing – GMP; formulation development – non-GMP; pre-formulation studies; lyophilization cycle development; and packaging, labeling, stability testing and storage capabilities.
  • Five different injectable dosage forms (standard potency): lyophilized parenterals; emulsions/liquid formulations; parenteral solutions; parenteral suspensions; and sterile powders – non penicillin/cephalosporin.
  • Nine different injectable package types (standard potency): ampules, large- and small-volume bags; dual- and single-chamber cartridges; large volume glass bottles; dual- and single-chamber pre-filled syringes; and glass vials.
  • Project acceptance criteria, with options for antibiotics, controlled substances, and substances requiring high containment or segregation, including cytotoxic/cytostatic.
  • Standard potency GMP vial options for lyophilization and vial processing.
  • Regulatory approvals and certifications.

Dataset for Solid, Semi-Solid/Liquid Phase I/II CTM and Formulation:

  • Eight different dosage forms: aerosol; gum; non-sterile liquids; metered dose inhalers; semi-solids; soft gel capsules; sold dose; and transdermal.
  • Five categories of project acceptance criteria (each with additional sub-categories): antibiotics; controlled substances; other materials; substances requiring high containment or segregation; vaccines and viruses.
  • Twelve different development capabilities: clinical supplies manufacturing – GMP; extrusion; fluid bed; high-shear; instrumented press; low-shear; microencapsulation; micronization; roller compaction; spheronization; spray drying; and xcelodose.
  • Regulatory approvals and certifications.

The PharmSource STRATEGIC ADVANTAGE database also covers many other areas, including manufacturers of active pharmaceutical ingredients (APIs) – both large molecule and small molecule; analytical services; and commercial dose manufacturing and packaging. To learn more click here, or schedule a guided tour of the service.

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