13 Jun 2019
Lonza to expand HPAPI development and manufacturing capacity
  • Lonza will develop new facilities at its Visp, CH site in order to meet customer needs for highly potent API (HPAPI), in particular for the oncology market
  • Two 4m3-scale, multi-purpose production lines, expected online by July 2020.
  • New capacity completes Lonza's range of HPAPI capabilities from development to commercial scale manufacturing, including formulation and delivery.

Basel, Switzerland, 13 June 2019 – Lonza, a CDMO partner to the biopharma industry, today announced an investment in a major expansion of Highly Potent API (HPAPI) capacity at its Visp, CH site to meet increased market demand. Lonza has industry-leading capability in HPAPI development and manufacturing, complemented with particle engineering and specialized finished drug products for oral and parenteral delivery applications.

The announced investment will add two 4m3-scale, multi-purpose production lines for HPAPI manufacturing complementing Lonza's existing range of production capacities from lab to large commercial scale. A subsequent capacity optimization will also improve Lonza's flexibility in existing production lines, supporting shorter time-to-market and accelerated approval timelines for partners.

Lonza has entered into a long-term manufacturing agreement with AstraZeneca, and the new facility will support the delivery of a number of products from across their portfolio. The remaining capacity will allow Lonza to expand the offer to other clients.

“We are delighted to support one of our strategic partners in securing supply of innovative therapies for the treatment of cancer patients,” said Lee Newton, VP and API Business Unit Head, Lonza Pharma & Biotech. “Oncology continues as the leading indication in biopharma and we will continue to invest to meet the HPAPI development and manufacturing needs of our customers.”

Lonza is an established partner in developing and manufacturing HPAPI, with more than 20 years' experience in safely progressing more than 30 products from early-stage work to late-stage clinical or commercialization. The company has the capabilities in place to safely handle HPAPI to exposure levels up to 100ng/m3 across all manufacturing scales. With recent acquisitions, Lonza has also added particle engineering (micronization and spray drying) for improving bioavailability and final drug product formulation under full containment. Additionally, specialized oral dosage forms (soft gels and liquid-filled hard capsules) for solid oral low-dose/HPAPI applications have augmented the company's fill and finish drug product capabilities.

“We listen to our customers and understand that needs vary more than ever in the biopharma space”, commented Gordon Bates, President Chemical Division, Lonza Pharma & Biotech. “We have invested accordingly in both technology and scale to ensure that we enable our customers to bring new medicines to patients faster. Our creative suite of tailored business models are also key in partnering for success”

The HPAPI capacity expansion is expected to be on-line by July 2020. More information on Lonza's HPAPI services and capacity can be found at pharma.lonza.com