Supplier News: Piramal, MilliporeSigma, Olon & More
The latest from CDMOs, CMOs, and suppliers featuring Piramal Pharma Solutions, MilliporeSigma, Lonza, Olon, Sartorius, INCOG BioPharma Services, Aptar, and Clinigen. Highlights below.
Chemicals/Chemical API Manufacturing
* Piramal Pharma Solutions Brings On Line New API Mfg Plant
* Olon Investing in New R&D Hub
Biologics Manufacturing
* MilliporeSigma To Invest $472 M To Expand Membrane, Filtration Mfg
* Sartorius Expands Mfg Plant in Tunisia
Formulation Development/Drug-Product Manufacturing
* Lonza To Expand Inhalation Services
* Piramal Pharma Solutions Opens Mfg Area for Solid-Dose Products
* INCOG BioPharma Services Opens New Biomfg Facility
Packaging
* Aptar Adds Mfg of Blister Packaging at European Site
General
* Lonza, Israeli Venture Capital Fund in Pact for CDMO Services
* Clinigen To Open New US Sites for Clinical Supplies Services
Chemicals/Chemical API Manufacturing
Piramal Pharma Solutions Brings On Line New API Mfg Plant
Piramal Pharma Solutions, a CDMO of active pharmaceutical ingredients (APIs) and drug products, reports that a new API manufacturing plant at its site in Aurora, Ontario, Canada, has come on line and successfully completed its initial production run
The new plant, built as part of a CAD $30-million (US$23-million) capital investment in the Aurora site, features more than 10,000 square feet of new manufacturing space and includes two new reactor suites with additional filtration and drying capabilities. It will expand the company’s ability to produce clinical to commercial-scale APIs, including highly potent APIs requiring an occupational exposure limit (OEL) of 1mcg/m3.
Source: Piramal Pharma Solutions
Olon Investing in New R&D Hub
Olon is investing EUR 10 million ($10.6 million) to create a central research hub at Rodano, Milan, Italy, dedicated entirely to research laboratories for developing active pharmaceutical ingredients (APIs) and manufacturing processes. The research hub, at is headquarters in Milan, will integrate with the company’s seven existing research centers and the 11 plants in its manufacturing network.
The new R&D hub will include a laboratory for process safety and research for scale-up and transfer processes and will also have an analytical R&D area for the development of new synthesis methods and new APIs from early-phase development. It will also include a process development laboratory with a team focusing on the development of advanced processes. Construction work will get underway in May 2022, and the center is expected to be completed and operational in the second quarter of 2023.
The research hub will also support new technologies, including biocatalysis and photochemistry and the growth in its R&D team, with up to 50 new researchers being hired to bring the total number of people assigned to research activities to around 350.
Separately, to further expand and increase its internal capability in developing new APIs, Olon is investing in a new spray dryer at its existing R&D center in Milan. The new equipment will be complementary to freeze dryers, with which the R&D center is already equipped.
Source: Olon (R&D hub) and Olon (spray dryer)
Biologics Manufacturing
MilliporeSigma To Invest $472 M To Expand Membrane, Filtration Mfg
MilliporeSigma, the life-sciences arm of Merck KGaA, has announced plans to invest approximately EUR 440 million ($472 million) to increase membrane manufacturing capacity in Carrigtwohill, County Cork, Ireland, and to build a new filtration manufacturing facility at the Blarney Business Park in County Cork, Ireland.
With the more than EUR 290-million ($311-million) expansion in Carrigtwohill, MilliporeSigma is adding a manufacturing facility for the immersion casting of membranes. These membranes support new therapies and gene therapies, as well as applications, such as virus sterilization. The announcement follows a EUR 36 million ($39 million) investment at the same site in 2021 for a second lateral flow membrane manufacturing product line. Now formally open, this facility produces lateral flow membranes, most commonly used in rapid diagnostic testing for rare diseases as well as COVID-19 testing.
At Blarney Business Park, MilliporeSigma plans to build a new filtration manufacturing facility for almost EUR 150 million ($161 million).
The total investment will create more than 370 permanent jobs by the end of 2027.
Source: Merck KGaA
Sartorius Expands Mfg Plant in Tunisia
Sartorius, a provider of products and services for the life sciences, has expanded its manufacturing site in Tunisia, Africa, through an EUR 20 million ($21 million) investment to
increase the production of fluid-management technologies. The investment covers a new 10,000-square-meter building and corresponding operation equipment at its existing site in M’Hamdia, Tunisia.
The extension includes cleanrooms totaling approximately 2,400 square meters with adjacent warehouse and logistics facilities. Sartorius currently has almost 800 employees in M’Hamdia and anticipates job growth at the site in the future.
Source: Sartorius
Formulation Development/Drug-Product Manufacturing
Lonza To Expand Inhalation Services
Lonza has announced plans to invest in additional inhalation capabilities at its manufacturing site in Tampa, Florida. The investment will fund the build-out of an additional inhalation testing capacity at the site, which is specialized in development, clinical, and commercial manufacturing of small molecule-based therapies targeting respiratory diseases and disorders.
The new laboratories will be equipped with analytical equipment and a containment system for highly potent active pharmaceutical ingredients to provide specialized performance testing, including aerosolized particle analysis. The new laboratories are expected to begin operations in June 2022.
Source: Lonza
Piramal Pharma Solutions Opens Mfg Area for Solid-Dose Products
Piramal Pharma Solutions, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has opened a new production block for solid-dose products at its drug-product site in Pithampur, Madhya Pradesh, India.
The new production area can handle batch sizes of 150 to 600 kilograms to increase the site’s capacity to produce oral solid-dosage form drug products. With the addition of the new block, the site’s total production capacity increases from 3 billion doses to 4.5 billion doses.
Source: Piramal Pharma Solutions
INCOG BioPharma Services Opens New Biomfg Facility
INCOG BioPharma Services, a CDMO of sterile injectables, has opened a new manufacturing facility in Fishers, Indiana. The 90,000-square-foot fill–finish manufacturing facility formulates and fills injectable drugs into vials, syringes and cartridges.
Source: INCOG BioPharma Services
Packaging
Aptar Adds Mfg of Blister Packaging at European Site
Aptar CSP Technologies, part of the Aptar Group, has added manufacturing for blister packaging for oral slide dose drugs in Europe.
The expansion is part of an effort to expand production of the company’s Activ-Blister technology globally and is the result of a collaboration between Aptar CSP, Uhlmann, a pharmaceutical packaging equipment manufacturer, and Ivers-Lee, a CDMO.
Source: Aptar CSP Technologies
General
Lonza, Israeli Venture Capital Fund in Pact
Lonza and the Israel Biotech Fund (IBF), a Rehovot, Israel-based venture fund investing in Israeli and Israeli-related biotech companies, have formed a framework agreement under which Lonza will provide pre-investment due-diligence support and offer IBF’s portfolio companies with tailored advice and services for the development and manufacturing of biologics and small molecules. In turn, Lonza gain access to IBF’s portfolio companies.
Under the two-year agreement, Lonza will advise IBF in review of candidate biotech targets and provide an offering, advice, and services to IBF’s portfolio companies and provide development and manufacturing services for drug substances and drug product to IBF’s portfolio companies
Source: Lonza
Clinigen To Open New US Sites for Clinical Supplies Services
Clinigen, a Burton upon Trent, UK-based specialist pharmaceutical services company, is opening a new satellite facility in Fargo, North Dakota, and Malvern, Pennsylvania, to service large-scale clinical trial supplies. The two new satellite facilities will allow Clinigen to support GMP storage and distribution and cold-chain management services, with new walk-in refrigerators and freezers, for 2-8°C, – 20°C, as well as -80°C storage.
Source: Clinigen
