Nottingham, UK – Molecular Profiles Ltd., a subsidiary of Columbia Laboratories, Inc., (Nasdaq: CBRX) has expanded its capsule filling capability following significant investment into new equipment at its clinical manufacturing site in the UK.
The contract development and manufacturing organisation (CDMO) has purchased a capsule bander, which enables the company to now offer liquid filling into capsules, complementing its existing powder and semi-solid capsule filling capability.
Molecular Profiles has also added a second capsule filling machine that provides increased capacity, greater capsule fill weight range and improved fill weight accuracy, with up to four-times the output of an existing machine.
Dr Rob Harris, chief technical officer at Molecular Profiles, said: “The investment in capsule banding is a natural extension to our oral dosage form manufacturing capabilities and will allow us to produce liquid-in-capsule formulations, which can be particularly beneficial for poorly soluble and potent compounds.
“Given that many early phase trials tend to involve capsules, our new filling machine gives us much greater dosage flexibility. We can manufacture for relatively small scale early stage trials and also now have the enhanced capacity that allows us to scale up to Phase III.”
This is the latest major investment at Molecular Profiles after the company recently created a new enabling technologies team and invested in GMP hot melt extrusion (HME) technology to further enhance its expertise in the processing of poorly soluble molecules.
Dr Harris added: “We are often involved in the pre-formulation and formulation development of liquid-based dosage forms particularly when it involves overcoming solubility issues. At this very early stage, our enabling technology platform facilitates our technical team in terms of screening compounds and selecting the most efficient development pathway for clients based on a foundation of science.
“So this new equipment now provides us with the full tool kit for manufacturing pretty much the full range of oral dosage forms.”
Working with leading pharmaceutical and biotech drug development companies worldwide, the CDMO specialises in advanced characterisation, product development, clinical trials manufacturing and analytical support.
Its MHRA-licensed site enables the company to manufacture a range of dosage forms, including potent compounds and controlled drugs, spanning solids, liquids, and semi-solids such as capsules, tablets and inhaled products.
Molecular Profiles also recently announced a strategic alliance with XenoGesis that brings expertise in preclinical drug metabolism and pharmacokinetics (DMPK) into the formulation development process.
The company also shares a close alliance with contract research and chemistry specialist Onyx Scientific. By utilising Onyx Scientific’s expertise in custom synthesis, process development and solid state chemistry, the partnership enables the two organisations to deliver end-to-end pharmaceutical development services from initial drug discovery through to the later phases of clinical development.