Page 166 - CW E-Magazine (8-10-2024)

News from Abroad News from Abroad

GROWING DEMAND ADVANCED DRUG DELIVERY
Spain’s Agarose Bead Technologies expands resins PCI Pharma Services invests over $365-mn in EU,

production capacity US facilities

Agarose Bead Technologies (ABT), PCI Pharma Services, a US-based
Spanish manufacturer of agarose resins, contract development and manufactur-
has completed a major expansion at ing organisation (CDMO), is investing
its facility located in Northern Spain, more than $365-mn in infrastructure
Burgos. The 1,000-sq.m. addition supporting the clinical and commer-
positions ABT as one of Europe’s cial-scale fi nal assembly and packaging
largest manufacturers of agarose resins of drug-device combination products uti-
and helps meet the growing global lising advanced drug delivery systems,
demand for agarose resins in the pharma- with an emphasis on injectable formats.
ceutical and bioprocessing industry.
Comprising new and expanded facili-
The Burgos site now boasts two ties in both Europe and North America,
Highlighting the phased plan is a presence in Europe with a newly ac-
new state-of-the-art cleanroom facili- the effort is part of PCI’s global invest- comprehensive 475,000-square-foot quired built-for-purpose pharmaceu-
ties and has increased its annual capa- ment plan, is anchored and funded by project comprising 345,000 square feet tical packaging and device assembly
city to 100,000-litres of resins per year. recent new business, and is designed to for advanced drug delivery injectable facility near Dublin, Ireland providing
More storage space will also be availa- augment and accommodate future growth. packaging and 130,000 square feet of large-scale temperature-controlled storage
ble to accommodate large volumes of additional warehousing for products capabilities. Operations are scheduled
products. For PCI, the investments build upon in all development phases. The space to commence in Q4 2024, with the
antibodies, vaccines, and cell and gene manufacturers worldwide. “Our invest- 20-plus years of biologics expertise, a houses over 20 customer suites, with facility providing commercial-scale
The expansion comes as ABT solidi- therapies. As these therapies require ment in expanding the Burgos facility position highlighted by the company’s scalable technology for the clinical and packaging and assembly operations for
fi es its commitment to supporting the advanced purifi cation processes, the is a direct response to the increasing Biotech Centre of Excellence in Phil- commercial-scale fi nal assembly and injectables as well as oral solid dose
growing needs of biopharmaceutical demand for high-quality agarose resins global demand for high-quality agarose adelphia, US. That location employs packaging of vials, prefi lled syringes, (OSD) drug products.
companies engaged in the development has surged, and ABT’s expanded capa- resins,” said Ms. Carolina Egea, CEO precision handling equipment for pre- autoinjectors, and pen-cartridge com-
of novel therapies, such as monoclonal bilities aim to provide critical support to of ABT. fi lled syringes, syringe assembly and binations, complete with sophisticated Elsewhere in Ireland, PCI has bro-
Eurofi ns CDMO Alphora plans biologics facility labelling, vial labelling and cartoning, top-open cartoning technology and ken ground on a new packaging and
and autoinjector assembly. Recently, extensive fi nal assembly and functional device assembly services facility at its
in Canada PCI invested in complex, automated product testing to ISO standards. City North Dublin campus. Slated to
advanced drug delivery technologies to
begin operations in Q3 2025, the plant
enhance capabilities and capacities at PCI also is announcing plans for a will provide increased capacity for the
Canada-based Eurofi ns CDMO ted on Eurofi ns CDMO Alphora’s 14- is expected to provide Eurofi ns CDMO this facility. further 70,000-square-foot expansion fi nal assembly, labelling and packaging
Alphora Inc., a part of Eurofi ns CDMO acre campus in the Sheridan Research Alphora a suite of integrated solutions, dedicated to advanced drug delivery and of injectable drug products including
that provides active pharmaceutical Park in Mississauga. The facility will be building upon a 20-year history of Combined, the new projects further patient-centric drug-device combination vials, prefi lled syringes, and drug-
ingredient (API) and drug product (DP) equipped to the 2,000-L bioreactor scale, developing and manufacturing thera- bolster PCI’s ability to manage the full assembly and packaging. A response to device combination products such as auto-
development services, has announced employ single-use technology, and be peutics for the Canadian, US and ROW lifespan of such products, from sterile customer needs, the facility will support injectors. The facility also will include
the construction of a new GMP biolo- capable of running both fed-batch and markets. Eurofi ns CDMO Alphora said drug product development and manu- a range of low- to high-speed packaging cold chain packaging for injectable and
gics manufacturing facility in Missis- perfusion modes. It will provide a fully its expertise in APIs and highly potent facturing through clinical trial supply, technologies for a variety of advanced biologic products, as well as associated
sauga, Ontario (Canada), to manufacture integrated offering with a state-of-the- APIs (HPAPI) uniquely positions it to product launch and commercialisation. drug delivery categories, including but temperature-controlled storage.
monoclonal Antibodies (mAbs) and art sterile fi ll line with a capacity of up provide development and manufactur- not limited to vials, prefi lled syringes,
protein therapies for clinical and to 24.9-mn units annually. ing services for both small and large New US Centre of Excellence autoinjectors and on-body injectors. The “This substantial, multi-continent
commercial applications. molecules “under one roof”. This inte- In the US, PCI has plans for an ambi- plant is intended to be brought online in investment places PCI Pharma Services
This manufacturing facility invest- grated approach facilitates effi cient tious 545,000-square-foot expansion at two phases, with operations expected to at the forefront of the global advanced
The 50,000-sq.ft. biologics manu- ment follows the completion of Euro- product development and manufactur- its campus in Rockford, Illinois, dedi- commence in Q3 2025. drug delivery solutions and drug-device
facturing facility, scheduled for comple- fi ns CDMO Alphora’s development & ing, particularly for complex modali- cated to advanced drug delivery and combination product assembly land-
tion in April 2026, will be housed within pilot scale-up facility, operational since ties such as Antibody Drug Conjugates drug-device combination assembly and Expanded EU operations scape,” said Mr. Salim Haffar, CEO of
a new 112,000-sq.ft. building, construc- January 2024. This biologics initiative (ADCs), it added. packaging. Additionally, PCI is amplifying its PCI Pharma Services.

166 Chemical Weekly October 8, 2024 Chemical Weekly October 8, 2024 167

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