Supplier News: MilliporeSigma, Piramal, Olon & More
The latest from CDMOs, CMOs, and suppliers featuring MilliporeSigma, Piramal Pharma Solutions, Olon, Sartorius, PCI Pharma Services, TriRx Pharmaceutical Services, Aptar Pharma, Gerresheimer, and B. Braun Medical.
General
MilliporeSigma Reorganizes; Adopts New Operating Model
MilliporeSigma, the life-sciences arm of Merck KGaA, has announced several organizational changes and a new operating model.
Existing CDMO and contract testing services will be consolidated into one global organization, Life Science Services for traditional modalities, such as monoclonal antibodies and high-potency active pharmaceutical ingredients, and novel modalities, such as antibody drug conjugates and viral and gene therapies, along with the respective sales and marketing, R&D, manufacturing, and supply chain operations.
The Process Solutions business unit will focus on providing filtration devices, chromatography resins, single-use assemblies and systems, processing chemicals and excipients.
The Science and Lab Solutions business unit will combine the research solutions and applied solutions business units into one organization. The new business units will become effective April 1, 2022. Full details of the new business units can be found here.
Source: MilliporeSigma
Chemicals/Chemical API Manufacturing
Piramal Pharma Solutions Expands ADC Capabilities, Invests in API Mfg
Piramal Pharma Solutions, a CDMO of active pharmaceutical ingredients (APIs) and drug products, is investing £55 million ($74 million) to expand antibody-drug conjugate (ADC) capabilities at its facility in Grangemouth, Scotland, and upgrade API infrastructure at its facility in Morpeth, UK.
In the first phase of the Grangemouth site expansion, two new ADC manufacturing suites will be added and are slated to be operational by the third quarter of 2023. The building has been designed to accommodate further expansion, with planned future phases that include a new sterile fill–finish suite dedicated to ADCs and two additional large-scale manufacturing suites capable of handling increased batch sizes.
The £10-million ($13.5-million) investment at the company’s Morpeth site, includes new equipment, infrastructure, and utility systems. More than 400 people are employed at Morpeth, with approximately 160 directly in API operations. Piramal is investing £8 million ($10.8 million) directly, and the UK government is contributing £2 ($2.7 million) million to the project.
Source: Piramal Pharma Solutions
Olon Investing $30 M To Expand High-Containment Mfg
Olon has announced an investment of EUR 27 million ($30 million) in 2022/2023 to expand internal expertise and capacity for high-containment manufacturing.
The company recently completed a new large-scale high containment production line (OEL < 1 mg/m3) with an investment of approximately EUR 10 million ($11 million) at its site in Rodano, Italy. The new line enables Olon to produce highly potent APIs in large-scale product batches ranging from 30 to 250 kg
Source: Olon
Biologics Manufacturing
Sartorius Acquires Novasep’s Chromatography Biz
Sartorius, a provider of bioprocessing products and services, through its subgroup, Sartorius Stedim Biotech, has closed the acquisition of Novasep’s chromatography business. The business acquired generated sales of approximately EUR 40 million ($46 million) in 2020.
The portfolio acquired comprises chromatography systems primarily suited for smaller biomolecules, such as oligonucleotides, peptides, and insulin, as well as systems for continuous manufacturing of biologics. Since 2018, Novasep and Sartorius have been jointly developing optimized systems for a membrane-based chromatography technology.
Source: Sartorius
Formulation Development/Drug-Product Manufacturing
PCI Pharma Adds Sterile Fill-Finish Equipment
PCI Pharma Services, a CDMO and contract provider of packaging services, is continuing to expand its sterile fill-finish capabilities with the addition of three new automated sterile fill-finish machines for its facilities in San Diego, California, and Melbourne, Australia.
Purchased from Cytiva, this equipment can pivot between filling different sterile medications into vials and syringes. The addition of these machines comes after PCI’s recent acquisition of LSNE Contract Manufacturing, a CDMO of fill–finish and lyophilization services.
The company has invested in a Microcell Vial Filler and SA25 Aseptic Filling Workcell, in its San Diego, facility for projects from Phase I through Phase III. Additionally, a Microcell Vial Filler has been placed at its Melbourne site for early-stage services. The machines are already at PCI’s facilities and are expected to be fully operational in September 2022.
Source: PCI Pharma Services
TriRx Completes Acquisition of Elanco Mfg Facility
TriRx Pharmaceutical Services, a Norwalk, Connecticut-based CDMO serving bio/pharmaceutical and animal health markets, has completed its acquisition of Elanco Animal Health’s manufacturing site in Speke, UK. The two companies ahd agreed to a two-facility sale and long-term supply agreement in 2021, which covered a facility in Shawnee, Kansas, and the Speke, UK, site.
The Speke facility, initially built by Eli Lilly and Company, offers capabilities to manufacture human health and animal health products. The sale includes the physical assets of the site and the transfer of approximately 350 employees.
Source: TriRx Pharmaceutical Services
Packaging
Aptar Pharma Begins Build of New Packaging Mfg Facility
Aptar Pharma, a provider of consumer dispensing, active packaging, and drug-delivery products and services, has begun construction on a new packaging facility in Mumbai, India.
The new Aptar Mumbai facility is being built on a 3.5-acre site at the Palava Industrial
and Logistics Park at Taloja, Mumbai. Construction is expected to be completed by the first quarter of 2023.
Source: Aptar Pharma
Gerresheimer Expanding Glass Vials Capacity
Gerresheimer, a provider of glass and plastic packaging products for the pharmaceutical and healthcare industries, is increasing its glass vials capacity by 150 million vials per year at its facility in Wertheim, Germany. It is also increasing glass vials capacity at two sites in China and the US.
Gerresheimer has primarily served production from its plants in Boleslawiec, Poland, and Chalon, France.
Source: Gerresheimer
B. Braun To Build New IV Bag Mfg Site
B. Braun Medical, which develops, manufactures, and markets products for infusion therapy and pain management, has received final approval by the US Food & Drug Administration for its new pharmaceutical manufacturing plant in Daytona Beach, Florida.
The site will produce 0.9% sodium chloride for Injection available in B. Braun’s Excel Plus IV Bags in 1,000-mL and 500-mL sizes.
The new Daytona Beach facility is part of B. Braun’s plan to invest over $1 billion to alleviate IV fluid shortages by creating additional supply and manufacturing capacity in the US. The company also has IV solutions plant in Irvine, California.
Delivery of products from the Daytona Beach facility is expected to begin in late February (February 2022).
Source: B. Braun Medical
