USA — Aptar Pharma, a drug delivery and active materials science solutions and services company has delivered the first phase of its previously announced expansion program of approximately US$180 million to meet growing customer capacity needs for injection system solutions.

The multisite, international expansion project began in 2020 and is intended to significantly boost capacity across all product lines, ultimately enabling Aptar Pharma to produce over 10 billion injectable component units annually when completed.

Injectables account for approximately 50% of the pharmaceutical drug development pipeline, with an estimated 40% market share, according to recent market research.

Between 2016 and 2021, injectables experienced the highest compound annual growth rate (CAGR 16-21), driven primarily by biologics and the demand for high-value solutions such as Aptar Pharma’s PremiumCoat.

Aptar Pharma’s investment includes expanding and ramping up Aptar Pharma’s global manufacturing of PremiumCoat ETFE film-coated components, PremiumFill enhanced specification solutions, elastomer components, and vial stoppers.

The expansion program includes investments in France and the United States, totaling more than 23,000 square meters of manufacturing space.

The first phase of PremiumCoat capacity expansion, which includes new ISO7 clean rooms and advanced robotics, is already operational in Granville, France.

An additional factory utilizing cutting-edge technology will open in Granville, France, in early 2024 marking a new milestone in the transformation of Aptar Pharma and paves the way for a step change in capacity and high-tech efficiency.

Manufacturing capabilities based in the United States will also be operational by 2024 to better serve the local market.

The program also includes additional manufacturing expansion phases in both the United States and France.

Elsewhere, Japanese drug developer Eisai recently completed the construction of an injectable formulation research building christened Eisai Medicine Innovation Technology Solutions (EMITS), positioning it to continue its expansion beyond oral drug delivery.

The 10 billion Japanese yen (US$69 million) plant will manufacture drug delivery systems such as liposomal and lipid nanoparticle formulations and will serve as Eisai’s global base for formulation and modality research.

The facility’s completion comes just as one of Eisai’s top injectable prospects, the Biogen-partnered Alzheimer’s disease drug candidate lecanemab, achieved the primary endpoint in clinical trial.

As a general trend, CDMO consolidation has been particularly noticeable in the biologics market. Catalent’s acquisition of Paragon for US$1.2 billion in 2019 and Brammer Bio’s sale to Thermo Fisher in 2019.

In 2021, Sanofi agreed to effectively become a mega-CDMO by assisting Pfizer in the production of its COVID-19 vaccine, while Bayer and CureVac formed a multifaceted partnership in order to roll out 160 million vaccine doses by 2022.

Millipore Sigma, Merck KGaA’s life science arm, acquired German mRNA CDMO AmpTec, combining AmpTec’s PCR-based mRNA technology with Millipore’s expertise in lipids manufacturing to strengthen offerings across the mRNA value chain.

Most notably MilliporeSigma, which already provides lipids, the central delivery mechanism for mRNA therapeutics, to Pfizer-BioNTech for their COVID-19 vaccines.

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