This FAQ explains how aseptic processing, contamination control, and validation protect patients amid sterile injectable failures.
|Articles|January 26, 2018
Almac Group Expands Site in Ireland
Author(s)BioPharm International Editors
The contract development and manufacturing organization has invested £30-million (US$42 million) at its Dundalk, Ireland site to offer expanded clinical trial services.
Advertisement
Almac Group announced the completed expansion if its Dundalk, Ireland site in a Jan. 18, 2018 press release. Initially announced in January 2017, the £30-million (US$42 million) investment includes a quality control laboratory, packaging facility for commercial drug products, and a 79,000-ft2 European Distribution Centre for clinical trial supply. The site is scheduled to be fully operational by January 2019.
The site passed Health Products Regulatory Authority (HPRA) inspections of its clinical and pharma services. Subsequently, the company plans to become officially licensed to conduct qualified person batch certification and release for both clinical trial material and commercial drug product from its Dundalk facility. This recent expansion accompanies the existing clinical supply and drug product development operations offered at the company’s main site in Craigavon, Northern Ireland.
“Achieving these successful HPRA inspections is a key milestone. In addition, the announcement today of further expansion will ensure our current and future clients receive a seamless solution with access to the EU [European Union] marketplace,” said Alan Armstrong, CEO and Chairman of Almac Group, in a company press release. “Crucially, this will ensure an uninterrupted service provision through any uncertainty Brexit may bring, and for the future, keeping Almac as a global leader in the life-sciences sector.”
Over the past 18 months, the company has made a series of investments, including the expansion of operational capabilities and new hires in each of its main territories in the United States, Asia, and the United Kingdom.
Source:
Advertisement
Related to this article
Bimekizumab-bkzx (Bimzelx) produced ACR50 joint responses in 54.9% of psoriatic arthritis patients at week 24 vs 43.8% with risankizumab.
VG801 gene therapy improved vision through 12 months in a Stargardt disease trial as VeonGen aligned with FDA on its pivotal phase 3 design.
Matt Trupo, Richard Jaenisch, and Brian Drapeau explore how AI advances biological insights, drug-target discovery, and supply chains.
As access to low Earth orbit expands, space-based research is opening possibilities in drug discovery, formulation, and manufacturing. In Part 1, the authors look at how microgravity changes biology and chemistry in ways that can’t be reproduced on Earth and where it fits from target discovery to life cycle management.
Aldevron and IDT added PE Ultra prime editor mRNA and 6 ABE8e base editor mRNAs to help researchers edit DNA without double-strand breaks.
In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
3
Blackstone to Provide Pfizer Up to $1.5 Billion for Monthly GLP-1 Berobenatide Development
4
Beam's Risto-cel Meets Primary Endpoint in Sickle Cell Trial
5