API Services, Chemical Development & Manufacture

QC and analytical support, including method development and validation, method transfer and radiolabelling stability studies

With our extensive experience in the synthesis and analysis of stable and ¹⁴C isotope labelled compounds – from drug discovery through to launch. We can label any compound at any stage, including small molecules, peptides, and antibody drug conjugates.

¹⁴C is the radioisotope of choice in preclinical and clinical ADME studies. ¹⁴C avoids the challenges encountered with tritium labelling, including label exchange and the loss of label due to radioactive decay.

²H, ¹³C and ¹⁵N stable labels are routinely used to prepare stable labelled versions of APIs. Multiple labels are typically incorporated to ensure complete mass resolution from the unlabelled API.

Isotopic labelling imposes many synthetic challenges beyond those found in normal chemical synthesis. When the isotope is radioactive, this becomes even more demanding. That’s why we offer advice on the most appropriate label position for your molecule, including feasibility and metabolic stability.

We can provide a complete suite of solutions for your radiolabelling needs, including:
- Non-GMP and GMP Stable Labelling
- Facilities and Equipment
- ADC Labelling
- QC and analytical support, including method development and validation, method transfer and stability studies
- Storage and Re-purification

We are MHRA certified for ¹⁴C IMP and GMP compliance and we are fully equipped to deliver an industry-leading, cost-effective radiolabelling service.

From our state-of-the-art analytical laboratories in the UK and US, our highly skilled analysts deliver comprehensive solutions to support drug substance (API) and drug product development programs. Analytical and microbiological testing solutions for clinical and commercial drug product supply are also provided.

Our Skilled Professionals
We employ over 250 highly trained analytical scientists with expertise in all areas of drug development, including small molecules, peptides, conjugates and potent materials. Drawing upon our vast pool of scientific knowledge, we can greatly reduce the analytical challenges that typically arise during drug development.

Communication and scientific continuity is key, whether your analytical requirements are stand-alone or form part of a drug development or commercial manufacture project. Our analytical scientists work with our API / drug product formulation scientists, forming an integral part of the project team. This means they can share data, easily coordinate planning and scheduling, and deliver maximum efficiency.

Our Comprehensive Services
We support drug substance and drug product development from early phase to commercialisation and beyond.

Biocatalysis Solutions:  Biocatalysts are essential tools in chemical synthesis, particularly in the synthesis of pharmaceutical and fine chemical targets. As highly selective catalysts, they offer a direct and simple way to synthesise complex achiral and chiral compounds. The application of biocatalysts in the pharmaceutical and fine chemical industries continues to grow as it moves from the domain of specialised technology to mainstream methodology. This movement has been facilitated by the increasing commercial ‘off-the-shelf’ availability of biocatalysts. Almac has heavily invested in this area to secure the supply of selectAZyme^TM biocatalysts for clients’ non-GMP and GMP manufacturing projects.

Our Biocatalysis Group
Consisting of computational, molecular and micro biologists, enzymologists, organic chemists and analysts, the group has demonstrated expertise in gene identification, expression, enzyme evolution, fermentation, enzyme production and biotransformation scale-up.  Expertise ranges from enzyme production to the synthesis of complex chiral APIs from mg-tonne scale.

Our team is closely linked to the process chemistry and manufacturing chemistry groups, where enzyme discovery and development is integrated with screening and route definition. Each member of the team brings expertise to complex processes procedures and can rapidly implement an enzymatic process to significantly improve the yield and timelines of a multi-step synthesis.

In addition, Almac has recently acquired Arran Chemical Company which significantly increases our scale (a range of reactors up to 6,300L and total capacity of up to 45m3).  The new combined business will integrate Biocatalysis technology with large scale intermediates manufacture. The bespoke facility offers a full range of scales including kg lab, multi-purpose pilot plant and manufacturing plant.

Over 40 years’ Experience Manufacturing Solid, Oral Dosage Forms
Scaling up from our development services to full scale commercial drug product manufacture or transferring existing commercial products we can meet your commercial drug product manufacturing requirements.

Our range of commercial scale dry blending and wet granulation technology supports the commercial drug product manufacture of:

Tablets

• Immediate and modified release
• Uncoated and coated (including enteric coating)

Capsules

• Hard gelatin capsules (powders, pellets)

Powders

• Granules
• Oral powders for reconstitution

With blend sizes from 10kgs up to 2.5 tons, our range of state-of-the-art processing equipment can flex to the batch size requirements of your particular product needs.

Ensuring That Your Products Meet Specifications
We are MHRA licensed and have been successfully inspected by the FDA, Pmda, ANVISA, Turkish Ministry of Health and South Korea FDA. With UK Home Office approval, we are also licensed for the storage and processing of controlled drugs (schedules II-V). A quality led environment is the foundation of our operations and we impose comprehensive standard operating procedures, rigorous training and a range of process controls.

Customised Solutions
To support operational activities, we have a dedicated in-house engineering team who provide equipment maintenance and calibration, tooling design and machine prototype manufacture. With dedicated specialists in place, we are able to facilitate the rapid turnaround of tailored solutions and provide equipment designed to meet the unique requirements of each and every project.

We offer a wide range of commercial packaging solutions to meet your needs, from initial artwork and pack design, to commercial packaging and distribution.

From our UK and US commercial packaging facilities, we are able to serve global markets. We are MHRA and FDA licensed and have been successfully inspected by global regulatory authorities including PMDA, ANVISA, Turkish Ministry of Health and South Korea FDA. With DEA and UK Home Office approval we are also licensed for the storage and processing of controlled drugs (schedules II-V). Through comprehensive standard operating procedures, rigorous training, and a range of process controls, we can ensure that your products meet the required specifications.

Our high and low throughput packaging operations provide flexibility and efficiency in the processing of solid oral dose and sterile presentations. We’re able to support both high volume marketed products and niche / orphan drug launches.

- Primary Packaging
- Secondary Labelling and Packaging
- Advanced Packaging Technologies
- Dedicated Product Supply Managers 
- Customised Solutions

Complementing our commercial manufacturing and packaging services, we provide a range of commercial storage and distribution solutions for solid oral dosage forms and sterile biopharmaceuticals, for both niche / orphan drug products and large scale commercial market volumes.

Utilising our bespoke ERP system, we provide full traceability of all materials on site from receipt, storage, processing and final dispatch.

Meeting all your commercial storage requirements, we have multiple, modular GMP warehousing and storage capabilities for raw and in-process materials and finished goods. All our storage facilities are temperature mapped and qualified prior to release for operational use. The temperature of each facility is continuously monitored by a building monitoring system with any temperature excursion from the defined limits escalated in real time.

Working with a select number of approved distribution partners, from express couriers through to dedicated pharmaceutical carriers specialising in temperature controlled road freight and airfreight, we provide a range of customised distribution services; from large scale deliveries to wholesalers; to single unit distribution direct to pharmacies.

Almac’s peptide and protein technology offering is a key component within our suite of services.  We offer a complete range of peptide and protein services from catalogue products through to GMP manufacture from early phase to commercial launch.  We have a proven track record in high quality supply, whilst providing excellent customer service through the balance of technical expertise and project management within our MHRA audited facilities.

As specialists in the manufacture of complex and high quality peptides, we continually make significant technological advances to support your research and development programmes and routinely produce peptides in excess of 100 amino acids in length.

We are a reliable partner for GMP peptide manufacture across the drug development lifecycle, and have an established reputation for developing fit-for-purpose processes that will ensure the success of your drug development programme .

Almac’s experienced formulation scientists can develop a range of oral dose formulations for early stage clinical trials.

With both non-GMP and GMP facilities, flexible and efficient solutions are provided to develop a fit-for-purpose formulation for your early phase clinical trial.
For early phase First-in-Human (FIH) supplies, we offer a range of solutions:

Drug in Bottle / Liquid in Bottle
“Drug in Bottle” or “Liquid in Bottle” offers a flexible solution for your early stage clinical studies. Taking your anticipated dose range into account, we will complete solubility screening experiments with various co-solvents. We will then assess solution stability to ensure there is sufficient shelf life to cover the intended period of time.

Drug in Capsule
Filing drug or active pharmaceutical ingredient (API) directly into capsules is one of the quickest ways for you to enter Phase I clinical trials whilst requiring a minimum quantity of API. This approach can reduce time and financial investment at an early stage in the development process, by minimising the API required and reducing the scope of analytical work required to support your clinical trial application.

Manual / Semi-Automated Filling
For low volume capsule supply we can provide manual API filling of capsules. We can also use capsule boards which are engineered to suit the characteristics of your particular API and the doses required.

Automated Processing
Using the Xcelodose® system, we have the ability to fill formulations or API directly into capsules with a high level of accuracy. This system can dispense amounts from 100 micrograms up to 100 milligrams and beyond, into capsules from size 00 to 4. Dosing directly into capsules can reduce the amount of API required.[/expand]

Conventional Capsule / Tablet Formulations
Developing an initial solid oral dose formulation is still the preferred choice for many of our clients. Our highly skilled team has significant expertise in developing initial prototype formulations and identifying a number of potential formulations. Their dedicated work can provide you with the optimum formulation and process to bring forward to GMP manufacture.

Enabling Confidence and Security in the Supply Chain

Specialising in solid oral dosage forms, Almac has the technical experience and knowledge to develop robust formulations and manufacturing processes.

We have assisted many of our clients in the development of both immediate and modified release formulations, for their late stage clinical trials, registration batch manufacturing and commercial launches. Our expertise covers the development of the following dosage forms: