Paediatric Drug Development and Manufacture brochure

The 100,000sq ft facility not only expands our range of capabilities, but also reinforces our position as an industry leader in pharmaceutical development and commercial manufacturing with an ability to tailor our services to suit individual products.

Your integrated API and analytical services provider

The 100,000sq ft facility not only expands our range of capabilities, but also reinforces our position as an industry leader in pharmaceutical development and commercial manufacturing with an ability to tailor our services to suit individual products.

With more than 50 years’ experience, we offer a wide range of specialised packaging solutions to meet, and deliver your product launch and ongoing commercial needs.

Almac Group has announced the official opening of new GMP-qualified analytical stability chambers and office space at its US Headquarter campus in Souderton, Pennsylvania. This $2 million investment builds on the multi-million-dollar expansion of global analytical services and reinforces Almac’s commitment to meeting growing client demand.

Balancing speed with precision, our flexible suite of offerings provides you with a reliable, effective, and expert approach to support the successful and timely introduction and launch of your new product and market penetration into new territories.

Almac Sciences, a member of the Almac Group, has invested £500,000 in state-of-the-art instrumentation within its spectroscopy laboratories at its global headquarters in Craigavon, Northern Ireland. 

Our product development service spans early to late phase clinical programs, offering technical experience and dedicated project management, and a track record of on-time delivery from state-of-the-art facilities.

Dr Megan Smyth wins award for rising stars bringing fresh approaches in the pharma industry

Non-GMP & GMP stable & radiolabelling expertise14C labelling of drug substance for human AME studies
Stable & radiolabelled metabolite synthesis
Specialist expertise in peptide & bioconjugate 14C labelling
QC, Analytical & QA integration
MHRA regulatory approved for 14C GMP manufactureof drug substance

Almac Group, the global contract development and manufacturing organisation (CDMO), has today announced an £11m investment and the creation of over 100 new jobs to expand global analytical services capabilities. 

Over 30 years’ experience in peptide manufactureRapid throughput, high quality manufacture
Customised supply plan for your project needs
Free consultation on peptide design & manufacturability
Smooth transition to scale-up & cGMP manufacture
Strong emphasis on project management & customercare throughout project lifetime

Grant awarded to support the expansion of Almac’s small molecule API manufacturing plant

As a world leader in pharmaceutical services, Almac delivers early formulation development workprograms for DRF/PK/tox studies. Designed to maximise solubility and bioavailability withoutcompromising on chemical stability, the studies accelerate drug development to the clinic and minimizerisk in any downstream activities. Almac offer bespoke work packages specifically tailored to thephysiochemical properties of the API (BCS class II, III, or IV) for solubility or permeability enhancement.

Tonmya™ is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by positive results from two Phase 3 studies

New Drug Application (NDA) submission to the FDA planned for second half of 2024

As a world leader in pharmaceutical services, Almac deliversbespoke crystallisation development work programs for smallmolecules and peptides designed to provide a robust, scaleable,and transferrable crystallisation procedure to help accelerateclinical development and minimise risk in any downstreamactivities by eliminating batch-to-batch variability

The Almac Group has today announced the completion of two new purpose-built facilities at its headquarters in Craigavon, Northern Ireland meeting client demand in commercial manufacturing and packaging as well as peptide production.

As a world leader in pharmaceutical services, Almac delivers unrivalled polymorph,salt, co-crystal, and early crystallisation work programs designed to identify the mostdevelopable solid form of your API to help accelerate development to the clinic andminimise risk in any downstream activities.

The new custom-built facility will consolidate the existing warehouses to support all manufacturing and laboratory activities.

Expertise in long peptides, radiopharmaceutical precursors & peptide cocktailsSolid phase & liquid phase synthesis
Experience in conjugation to a wide range of chemical entities
Strong project management culture
Full support from in-house analytical & QA teams, & for CMC section preparation

Almac Sciences’ Technology Group was selected as the winner of the “Life Sciences Team of the Year” category  during this year’s Irish Life Sciences Awards ceremony, held on 6 July 2023 at Crowne Plaza Hotel, Dublin..

Almac has the expertise andcapabilities to deliver flowtechnologies from proof ofconcept reaction validitythrough to manufacture withdefined workflows

Strengthened collaboration with University College Dublin (UCD) that will focus on the development of novel continuous flow protocols for accessing new industrially relevant drug targets.

Almac’s biocatalysis expertise ranges from enzyme discovery, enzyme engineeringand enzyme production to the synthesis of complex chiral intermediates andactive ingredients, all based on selectAZymeTM technology. Challenge us with yourchemistry problems and see how we can successfully deliver biocatalysis solutionsand more...

Overall recognition received for compatibility, expertise, quality and reliability.

At Almac we have the expertise and capabilities to deliver enzyme technologies from their discovery through to commercial enzyme supply

Health Products Regulatory Authority (HPRA) has certified Almac Sciences Ireland (ASI) facility for testing of biologics after a successful audit

Providing comprehensive and flexible analytical solutions toaccelerate the development and approval of biologics

Expanded GMP manufacturing facility now operational for use in clinical and / or commercial manufacturing

Drawing upon our vast pool of scientific knowledge, we greatly reduce the analytical challenges that typically arise during drug development.

Almac Sciences offers services including API development & manufacture, radiolabelling, biocatalysis solutions, peptides & protein technology, pre-formulation, solid state and analytical services.

Scaling up from our development services to full scale commercial drug productmanufacture or transferring existing commercial products, Almac Pharma Servicescan meet your commercial drug product manufacturing requirements.Our range of commercial scale dry blending, and wet and dry granulation technologysupports the commercial drug product manufacture of granules and oral powders forreconstitution.

With over 50 years’ experience in providing packaging solutions, we understand theunique requirements for paediatric medication packaging. Almac’s comprehensiverange of paediatric packaging options ensures safety, convenience, and adherence toregulatory standards for children’s medications.

Almac has the flexibility to meet your complex kit assembly outsourcing requirements from low volume, manual kitting through to high volume, semi-automated processing to meet the needs of larger scale commercial market demands.

Meeting your commercial needs, we provide a wide range of customised commercial services from supporting your product launch, manufacturing and/or packaging your drug product, to securing your supply chain with global serialisation solutions.
 
In line with regulatory compliance, our facilities regularly undergo GMP inspections by MHRA, FDA, and HPRA. We hold GMP certificates enabling GMP development, manufacture, and packaging of products, as well as flexible GMP specific floorspace. Pre-qualified amenities within our floorspace include, power, compressed air, purified water, and RH control.

With over 55 years’ experience and commercial facilities in the UK, US and EU, our global reach and local expertise provides flexible, quality led commercial solutions from orphan drug launches to ongoing high volume commercial product manufacture, packaging and supply.

Commercial manufacturing: At Almac Pharma Services, we specialise in providing comprehensive solutions for commercial pharmaceutical drug manufacture. 

With 55+ years of experience and a commitment to excellence, we are your trusted partner in bringing life-saving medications to patients worldwide.We understand the complex and evolving landscape of pharmaceutical manufacturing. Whether it’s scaling up from clinical trials or optimising manufacturing processes, we are here to guide you every step of the way.

Insights into our Custom-built GMP commercial manufacturing facility measuring 100,000ft2 / 9,300m2

With over 55 years of experience, Almac combines expertise in oral dosage form
development and controlled release technologies to produce well-characterised and
reproducible dosage forms that release within specifications.

We follow rigorous containment protocols to protect both our employees and the environment, ensuring both safety and compliance at every step. Almac develops and manufactures oral dosage formulations containing high potency API from our state-of-the-art non-GMP and GMP facilities, with batch sizes ranging from gms to tons.

With more than 55 years’ experience, we offer a wide range of flexible specialised packaging solutions, including innovative ATMP packaging, to meet all your product launch and ongoing commercial supply needs.Streamline your pharmaceutical product launch and distribution with Almac's expert services

 

At Almac, we bridge the gap between drug substance and drug product. From pre-formulation all the way to GMP manufacture, trust Almac to transform your drug product’s potential into a clinical-ready solution.

The Almac Group is a global leader in providing a range of expert services and support across the drug development lifecycle.

Almac employs over 700 highly skilled analytical scientists across five global locations working in regulatory-approved GMP laboratories. With 55+ years of experience, our expert teams develop 1,000+ analytical methods and validate 250+ methods annually. Drawing upon an extensive range of analytical technology, combined with a wealth of analytical knowledge, we can add real value to your drug development and commercialisation programs.