Lonza, a specialty contract development and manufacturing (CDMO) partner to the biopharma industry, will add new highly potent API (HPAPI) manufacturing suites at its site in Visp, Switzerland. The expanded capacity is for the specific support of antibody-drug conjugate (ADC) payload manufacturing.
By leveraging the company’s more than 100-year experience in chemistry, biopharmaceuticals and small molecule drug process development and scale-up, Lonza as developed a reputation in manufacturing and support of both clinical development and commercial licensing of antibody-drug conjugates (ADCs).
The expansion is based on a tailored business agreement with a major biopharmaceutical partner that ensures ADC payload supply continuity and flexibility at reduced cost of goods
This latest expansion includes two new manufacturing suites. These new suites enable handling of a variety of highly potent products with occupational exposure levels down to 1ng/m3 and strengthen the overall bioconjugation capabilities of the company.
The expansion underlines the strategic position of antibody-drug conjugates in the Lonza Pharma & Biotech portfolio, with the company developing and producing all components of this increasingly important cancer treatment: cytotoxic payloads, antibodies and the required linkers.
The first of the two new HPAPI suites specifically supports a global biopharmaceutical partner by securing the long-term supply of highly potent ADC payloads.
The second suite will be available to other customers for similar HPAPI and payload development and manufacturing programs. The expansion also increases Lonza’s capabilities in providing fully scalable HPAPI and ADC solutions from lab to commercialization, which supports the accelerated timelines that many drug programs in this category require.
“By ensuring critical supply for the treatment of cancer patients, we are supporting one of our global partners in the oncology field,” said Maurits Janssen, Head of Commercial Development of the API Business Unit at Lonza Pharma & Biotech.
“Oncology continues to be the leading indication in biopharma and the main driver for bioconjugates. We continue to increase capabilities and capacity to meet the HPAPI development and manufacturing needs of our partners,” Janssen added.
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 HPAPIs to exposure levels down to 100ng/m3 across all manufacturing scales. These new suites will extend the options for companies developing APIs with even higher potencies.
“Our customers developing highly potent medicines need a partner whom they can trust to handle these toxic substances and to deliver in sync with their needs, whether for clinical or commercial supply,” said Gordon Bates, President Chemical Division at Lonza Pharma & Biotech.
“Combined with our expertise in biologics development, manufacturing, bioconjugation and sterile fill/finish, this new capability will offer further solutions for companies developing complex therapies,” Bates concluded.
Future of ADCs
The expansion confirms Lonza’s belief in the growing global therapeutic potential of ADCs which is, according to experts expected to grow to US $ 4bn by 2023, with double digit approvals within 3-years.
As part of this growth, novel payloads that target tumor-initiating cells on third generation antibody-drug conjugates or ADCs could come to market in the next couple of years. Driven by a healthy late stage pipeline, experts confirm that they expect the market for antibody-drug conjugates to expand at around 19% compounded annual growth rate (CAGR) between 2017 and 2030.
These predictions are based on a new analysis published in the 2018 edition of the CPhI Annual Report – the complete findings of which were released earlier this month at CPhI Worldwide in Madrid, Spain, the global pharmaceutical event held October 9 – 11, 2018.
Lonza’s HPAPI and ADC payload expansion, which is, in part, based on these expectations, is expected to be on-line by the end of 2019.
Disclosure: Lonza is one of the underwriting sponsors of ADC Review, Journal of Antibody-drug Conjugates.