Semi-Solids

Semi-solid dose products often feature intricate formulations with complex structural elements, which means they present unique manufacturing challenges. For example, controlling temperature and homogeneity are critical for semi-sold dosage forms to ensure the active pharmaceutical ingredient (API) is distributed evenly without any degradation. Your CDMO should offer specialized chemistry expertise and equipment capabilities to help you manufacture this complex dosage form with confidence.

Cambrex has the expertise and the facilities to support you, at any size or stage, with a range of services. We are equipped to handle non-sterile creams and gels, as well as sterile and non-sterile ointments, and offer development and production-scale suppository filling technology. When you partner with us, you benefit from the cost and time savings realized with an integrated service provider that combines all the technology, equipment, and scientific and engineering expertise needed to manufacture semi-solid dose products with a diversity of APIs or nonprescription substances.

Scale-Up and Site Transfer

We work closely with customers to facilitate the scale-up and site transfer of semi-solid dosage forms for commercial launch. From development through scale-up and manufacturing, we support the necessary formulation, engineering, analytical testing and validation work for a successful process.

Our facilities have an excellent track record of US FDA and Health Canada compliance, including the manufacturing of ointments, creams, and gels for all types of topical compounds. With stringent controls of aseptic conditions and highly trained production operators, we have established ourselves as a leading global provider of aseptic topical products. In addition, we offer a full range of microbiology and analytical QC services.

Sterile Semi-Solid Manufacturing Capabilities

• Tube sterilization through gamma irradiation and incoming tube logistics are managed by Cambrex personnel using validated methods and qualified protocols and vendors
• All compounding is carried out in a class C area
• Aseptic 0.22 µm filtration and in-situ steam sterilization are available
• Production can utilize glove ports for the transfer of sterile API via an aseptic transfer vessel
• Components are filled under Class A conditions
• Labelling and carton-packing services available
• A Krieger 600 MMD batch processor can handle sterile semi-solid batch sizes ranging from 200 kg to 450 kg
• An IWKA TF 20 robotic tube filler minimizes human contact in the tube-filling process
• Facilities are equipped to fill tubes ranging from 3.5 g to 100 g; we can manufacture bulk up to 200,000 kg annually

Non-Sterile Semi-Solid Manufacturing Capabilities

• Pilot, clinical trial material and commercial-scale manufacturing
• Segregated manufacturing suites
• Semi-solid cGMP batch sizes from 25 kg to 1000 kg
• Labelling and carton-packing services available
• Production capacity up to 325,000 kg of bulk topicals
• Full range of microbiology and analytical QC services available in support of the production of non-sterile semi-solids
• Development and pilot-scale Ekato Unimix SRC-150 units can handle batch sizes ranging from 25 kg to 150 kg; equipped with state-of-the-art vacuum de-aeration to handle viscous polymers
• A Romaco Unipac U 20100 automatic tube filler is capable of filling laminate, plastic, and aluminum tubes at high speed
• Equipped to fill tubes ranging from 2 g to 240 g and batch sizes up to 1,000 L

Suppository Manufacturing Capabilities

• Development and production-scale suppository filling machines available at our Whippany, NJ and Mirabel, Quebec facilities
• Production capacity over 100 million units annually