Lonza invests more in HPAPIs
Lonza is to expand high potency API (HPAPI) capacity at its main site at Visp, Switzerland, in response to demand. It will add two multi-purpose production lines, both of 4 m3 capacity, to its existing range of laboratory- to commercial-scale capacities and will subsequently optimise these to improve flexibility and reduce time-to-market.
In parallel, the company has entered into a long-term manufacturing agreement with AstraZeneca. The new facility, which is due onstream by July 2020, will be used to deliver multiple products to AstraZeneca for the treatment of cancer; the remaining capacity will be open to other clients.
Across all of its facilities, Lonza can handle HPAPIs down to exposure levels up to 100 ng/m3 at all scales. It has also, in recent years, added or expanded such related capabilities as micronisation and spray drying for improving bioavailability and final drug product formulation under full containment, as well as specialised oral dosage forms.
Separately, Lonza has launched its Lonza Engine technical service platform, which, it said, “is designed to address the needs of customers throughout the entire small molecule drug development process”. This combines the firm’s bioavailability enhancement, encapsulation and clinical development technologies with the equipment of the former Capsugel and Micromacinazione businesses, notably micronisation, capsule filling and sealing, and powder micro-dosing.
In April, Lonza Pharma & Biotech launched SimpliFiH, which similarly unites its technologies that address bioavailability problems, including drug substance, solid state characterisation, phase-appropriate drug product in multiple forms for first-in-human studies and basic analytical studies. This is targeted mainly at innovators whose early-stage molecules have solubility challenges. It also includes specific, streamlined templates specific to further reduce time, cost and complexity for these studies.