ロンザ株式会社 受託製造開発事業部

[低分子医薬品] Lonza Celebrates the Grand Opening of a New Facility for ADC Payload Manufacturing

登録日:2020/11/09

▪ The first manufacturing suite at the Visp (CH) site is dedicated to the manufacturing of antibody-drug conjugate drug-linker and complementary to our full-service capability for HAPI from bench-scale through 10m3 scale

▪ The new suite enables handling of a variety of highly potent products with occupational exposure levels down to 1ng/m3 and strengthens the overall bioconjugation capabilities of Lonza in Visp

▪ Expansion is based on a tailored business agreement with a major biopharmaceutical partner that ensures ADC payload supply continuity and flexibility


Quote from Maurits Janssen, Strategic Business Development Small Molecules, Lonza:
“Supply from the facility is critical, and by supporting one of our global partners in the oncology field, we are enabling the treatment of many cancer patients. Oncology continues to be the leading indication in biopharma and a key driver for highly potent ingredients such as antibody-drug conjugates. We continue to add capabilities and capacity to meet the development and manufacturing needs of our partners in this field to answer to their increasing demand.”

Quote from Gordon Bates, President Small Molecules, Lonza:
“This partnership is a great example of how we can support both early and commercial-stage biopharmaceutical companies through innovation in manufacturing technology and flexible business models. Our customers developing highly potent and increasingly complex medicines need a partner whom they can trust to handle these toxic substances throughout their lifecycle and to deliver in sync with their needs, whether for clinical or for commercial supply. Our partner has recognized the value in combining expertise in biologics and chemistry on one site and this investment has expanded our collaboration.”

Basel, Switzerland, 05 November 2020 – Lonza, a specialty CDMO partner to the biopharma industry, today inaugurated the first of two manufacturing suites for antibody-drug conjugate (ADC) drug-linker (payload) manufacturing at the Visp (CH) site. This first manufacturing suite handles compounds with occupational exposure levels down to 1ng/m3 and is dedicated to the manufacturing platform for ADC drug linkers. This expansion underlines the strategic position of ADCs in the Lonza portfolio, with the company developing and producing all components of these increasingly important cancer treatments: cytotoxic payloads, antibodies and the required linkers on one site.
Due to COVID-19 measures, the opening was held as a virtual opening ceremony, connecting multiple customers and Lonza sites worldwide after the first process validation was completed successfully and manufacturing for in-market supply started.
The first of two state-of-the-art, highly-potent API (HPAPI) suites supports a global biopharmaceutical partner by securing their long-term supply of highly-potent ADC payloads. The suite has been in operation since March of this year. A second suite will become available to other customers early in 2021 for similar HPAPI and payload development and manufacturing programs.
These new suites will extend the options for companies developing APIs with even higher potencies. Moreover, they will increase Lonza’s capabilities to provide fully scalable HPAPI and ADC solutions from lab to commercialization, supporting the accelerated timelines that many drug programs in this category require.

About Lonza
At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.
We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.
Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at www.lonza.com and follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.

About Highly-Potent API at Lonza
Lonza is a globally leading 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 HPAPIs to exposure levels down to 100ng/m3 across all manufacturing scales. HPAPI development and manufacturing is complemented by contained particle engineering and specialized drug products inclusive of oral solid and parenteral options within its global site network.
Click here(https://pharma.lonza.com/offerings/small-molecules-and-intermediates/hpapi-product-handling) for more information on Lonza’s HPAPI services and capacity.



 

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