Almac Pharmaceutical Development

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

Your integrated API and analytical services provider

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

Tailor-made Pharmaceutical Development & Commercial Solutions

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.

By Dr Colin Lorimer, Formulation Development Manager, Almac Pharma Services

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

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 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..

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.

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.

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

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

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

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

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

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.

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

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.

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 can help you achieve success in your cancer research programmes using our range of peptide technologies:• Specialist research reagents
• Peptide conjugates
• Custom peptide synthesis
• Individualised cancer vaccines (NeoPeptidesTM)

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

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...

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

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

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

Almac Pharma Services offers early and late phase pharmaceutical development. Its expertise also includes pharmaceutical product launch & distribution, commercial drug product manufacture, commercial packaging, serialisation and commercial storage & distribution.

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

We offer a wide range of tailored commercial packaging solutions and global expertise, to meet your product launch (including rapid launch) and commercial needs.

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 increasing demand for packaging solutions for auto-injectables, and acompressed timeline to supply these products to patients, Almac Pharma Services’commercial facilities in the UK, EU & US, provide flexible, quality led commercialpharmaceutical packaging solutions tailored to meet your specific needs, from initialartwork and pack design to commercial drug product packaging, serialisation anddistribution.Our high and low throughput commercial pharmaceutical packaging operations provide flexibility and efficiency inthe processing of all types of presentations. We’re able to support both high volume marketed products and niche/orphan drug launches and ongoing lifecycle supply.

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.