Our
Services

We provide a range of specialist pharmaceutical contract manufacturing services in the spray drying of aqueous and organic solutions, of conventional APIs, HPAPIs, lipids, proteins, and in capsule filling for dry powder.

Spray drying

Spray drying is one of our core areas of expertise.

Regarded as the most flexible formulation technology for the delivery of APIs and larger biomolecules, it is widely used across the pharmaceutical industry to transform a liquid feed into a powder in a single continuous process.

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Capsule filling

We are experts in the fast, flexible, and efficient filling of hard gelatin capsules of any size.

Using the latest capsule filling technology, we have the resources, flexibility, and capabilities to meet the full range of project requirements.

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Nanomilling

Nanomilling is used to reduce the particle size of a poor water-soluble APIs before spray drying. With high reproducibility and easy scalability, the process is used to increase the surface area of an API and create a nano-suspension.

The process takes place in a liquid vehicle, where polymeric or ceramic beads grind the API.

Quality unit

Our quality assurance team guarantees full cGMP compliance with all applicable regulatory requirements and standards.

Our quality systems are approved and regularly inspected by EU GMP, US FDA, Swissmedic and Japanese authorities and Micro-Sphere is registered by the FDA as a FDF (Finished Dosage Facility).

We also offer pre- and post-launch regulatory support to customers, providing all the documentation required for submissions.

Laboratory and analytical services

Our analytical laboratory is equipped with state-of-the-art instruments and is fully temperature and humidity (RH) controlled.

Our core analytical services include:

  • Development, optimization, validation, and transfer of analytical methods
  • Analytical testing on stability samples, IPC, and final release analysis
  • Segregated inhalation drug testing area, including aerodynamic particle size distribution (aPSD), and delivered dose uniformity (DUSA)

We can also undertake stability studies (ICH) and customized conditions in our stability cabinets; impurities and degradation testing; microbial endotoxin testing and contract analytical services.

Pharmaceutical project management

Whether your project requirement is at a clinical or commercial scale, our highly experienced team can help.

After a first evaluation of the project, we will assign a dedicated project team with expertise across every aspect of the project (technical, analytical, commercial, and quality).

We will then define and apply a conceptual and operational roadmap to ensure the project stays on a successful path, keeping time and costs to a minimum, while enabling the project team to keep the process moving forward effectively and efficiently.

Upcoming
Events

8th-10th

December

DDL 2021

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9:00 am

Virtual - Online

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Meeting