Supplier News: Agilent, CordenPharma, Baxter & More
The latest from CDMOs, CMOs, and suppliers featuring Agilent Technologies, CordenPharma, Euroapi, Sterling Pharma, Baxter, Alcami, Argonaut Manufacturing Services, Cytiva and Aurisco.
Chemicals/Chemical API Manufacturing
* Agilent Investing $725 M To Expand Oligonucleotide Mfg
* CordenPharma in $1-Bn Peptide Supply Pact; Updates Expansion Plan
* Sterling Pharma Acquires API Mfg Facility from Novartis
* Euroapi Investing $43 M To Expand Vitamin B12 Mfg
* Cytiva, Aurisco Partner To Build Oligonucleotides Mfg Facility
Formulation Development/Drug Product Manufacturing
* Baxter Announces Strategic Plans, including for CDMO Business
* Alcami Completes Sale of Company to Two Investor Groups
* Argonaut To Add Fill–Finish Production Line
Chemicals/Chemical API Manufacturing
Agilent Investing $725 M To Expand Oligonucleotide Mfg
Agilent Technologies, a Santa Clara, California-based technology company and CDMO of nucleic acid active pharmaceutical ingredients (APIs), is investing approximately $725 million to double \manufacturing capacity of therapeutic nucleic acids at its facility in Frederick, Colorado, by adding two new manufacturing lines (known as trains C and D).
The addition of trains C and D at the facility will enable Agilent to meet growing demand for siRNA, antisense and CRISPR-guided RNA molecules. Agilent expects customer shipments from the expansion to begin in 2026.
The new investment is in addition to a previously announced $150-million investment to add 25,000 square feet of manufacturing capacity to the Frederick facility, which will go live earlier this year.
Source: Agilent Technologies
CordenPharma in $1-Bn Peptide Supply Pact; Updates Expansion Plan
CordenPharma has signed a multi-year potential $1-billion agreement, commencing in 2023, for the contract manufacturing of a large-volume peptide at its CordenPharma Colorado facility.
The manufacturing agreement will potentially cover a value of $1 billion, depending on actual production over the term of the agreement.
As part of the pact CordenPharma plans to further expand both its large- and medium-scale peptide manufacturing capacity at its Colorado and Frankfurt sites. The company is pursuing a large investment program in 2023 across its global facility network to expand capacities and technologies in key areas such as peptides, lipids, and injectables, with an overall planned investment of over EUR 200 million ($215 million).
Source: CordenPharma
Sterling Pharma Acquires API Mfg Facility from Novartis
Sterling Pharma Solutions, a Dudley, UK-based CDMO of small-molecule active pharmaceutical ingredients (APIs) and intermediates, has completed its acquisition of an API manufacturing facility in Ringaskiddy, Ireland, from Novartis. The deal was initially announced in March 2022.
The 111-acre site includes multiple commercial-scale production buildings, with a total vessel capacity of 175 cubic meters across over 30 reactor trains, a small-scale facility, and a development and support building housing 14 development and analytical laboratories. The facility also includes capabilities for manufacturing highly potent APIs, solid phase and agitated vessels for peptide coupling and synthesis, as well as various milling and micronization equipment for drug-substance processing. Three hundred and fifty staff at the site have been transferred to Sterling’s employment.
The deal includes an ongoing supply agreement with Novartis to continue to manufacture APIs for cardiovascular, immunology and oncology medicines at Ringaskiddy.
The acquisition is part of a growth strategy for Sterling Pharma, which has seen the number of employees increase from 300 employees across two sites in 2022 to 1,300 employees based across five facilities in the UK, US and Europe.
Source: Sterling Pharma Solutions
Euroapi Investing $43 M To Expand Vitamin B12 Mfg
Euroapi, a Paris-headquartered CDMO of small-molecule active pharmaceutical ingredients and intermediates, is investing EUR 40 million ($43 million) at its site in Saint-Aubin-lès-Elbeuf, France to implement new technology for vitamin B12 production. The investment also includes a EUR 7.9 million ($8.5 million) investment from the French government.
This project includes the expansion of Saint-Aubin-lès-Elbeuf site and a new nitrite-free fermentation technology that would increase production by 60%. The project should enable the company to increase its manufacturing capacity by 2025, and full capacity of vitamin B12 production is expected to be reached by 2027.
The expansion at the site is in addition to an EUR 24-million ($26-million) investment announced in July 2022 for the construction of a biomass to reduce carbon dioxide emission of the site by almost 76% in 2026. The two projects are synergetic as the 17-MW biomass equipment was designed to support the site’s vitamin B12 production capacity increase program.
Source: Euroapi
Cytiva, Aurisco To Build Oligonucleotides Mfg Facility
Aurisco, a Shanghai, China-based bio/pharmaceutical company and CDMO of active pharmaceutical ingredients, is partnering with Cytiva to build a commercial-scale oligonucleotide manufacturing facility in Yangzhou, China. The manufacturing site will have capacity to produce 200 kilograms of oligonucleotides per year.
The facility will use Cytiva’s Oligo FlexFactory an oligonucleotide production platform. The Oligo FlexFactory platform is the first of the three planned commercial manufacturing lines by Aurisco at the site. Cytiva will provide its Oligo FlexFactory GMP platform and various technical and service support, such as talent training, process design of the manufacturing site, as well as life-cycle project management.
Source: Aurisco
Formulation Development/Drug Product Manufacturing
Baxter Announces Strategic Plans, including for CDMO Business
Baxter, a bio/pharmaceutical company, has announced a series of moves to improve its performance, including pursuing strategic alternatives for Baxter BioPharma Solutions, the company’s CDMO business, which would include a potential sale or other separation options. The CDMO is a provider of formulation and fill-finish of sterile injectables and formulation and development services for suspensions and lyophilized dosage forms.
The announcement for its CDMO business was part of a larger news announcement by Baxter, which reported on other plans to improve its financial performance, including plans to spin off the company’s Renal Care and Acute Therapies global business units into an independent, publicly traded company and to implement a simplified commercial and manufacturing footprint to enhance underlying business performance.
Source: Baxter
Alcami Completes Sale of Company to Two Investor Groups
Alcami, a Wilmington, North Carolina-based CDMO of drug products and analytical testing services, has completed the sale of the company to two investment groups: GHO Capital and The Vistria Group. The investor groups acquired Alcami from two other investor groups: Madison Dearborn Partners and Ampersand Capital Partners. The acquisition was first announced in November 2022. GHO Capital and The Vistria Group have acquired a 50/50 controlling interest in Alcami. Ampersand and Alcami management have reinvested equity as part of the acquisition. Financial terms were not disclosed.
Source: Alcami
Argonaut To Add Fill–Finish Production Line
Argonaut Manufacturing Services, a Carlsbad, California-based CDMO of fill-finish and lyophilization services, is adding a manufacturing line at its Carlsbad facility capable of filling vials, syringes, and cartridges for clinical and commercial drug products. Argonaut’s added capacity for vials and new capabilities to support syringe and cartridge filling will more than double the capacity of the existing filling line. The new filling line is expected to be GMP-ready for clinical and commercial business in the first half of 2025.
Argonaut will also make investments in support of its molecular diagnostics business
Source: Argonaut Manufacturing Services
