14C Radiolabelling

14C Radiolabelling
Product Description

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.

Almac Group ltd

  • GB
  • 2015
    On CPhI since
  • 5000+

Almac Group ltd

  • GB
  • 2015
    On CPhI since
  • 5000+

More Products from Almac Group ltd

  • API Services, Chemical Development & Manufacture

    Product API Services, Chemical Development & Manufacture

    Almac’s strength in API development and manufacture is proven by being the partner of choice for many pharma and biotech companies seeking integrated drug development solutions from molecule to market.

    Our technical expertise and extensive facilities enable us to offer integrated API contract manufacturing solutions through all stages of the drug development lifecycle.  We are fully supported by dedicated analytical and regulatory teams.

    In addition, we offer numerous support capabilities, including: rapid implementation of chromatography for purification, containment equipment for potent compounds and micronisation to control particle size.  Our dynamic team successfully address many complex project challenges, and implementing our on-site biocatalysis  technology expertise is one example of our responsive solutions.

    Project management is critical for the effective execution and delivery of our  customers’ complex projects.  Our project managers are experienced scientists, working with clients to anticipate and respond to project priorities.

    Almac has an excellent regulatory history with regular inspections by all appropriate regulatory bodies (FDA, MHRA) and our clients.

    Project management is critical for the effective execution and delivery of our  customers’ complex projects.  Our project managers are experienced scientists, working with clients to anticipate and respond to project priorities.

    Almac has an excellent regulatory history with regular inspections by all appropriate regulatory bodies (FDA, MHRA) and our clients.

  • Analytical Services

    Product Analytical Services

    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

    Product Biocatalysis Solutions

    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 selectAZymeTM 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.

  • Commercial Drug Product Manufacture

    Product Commercial Drug Product Manufacture

    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:

      • Immediate and modified release
      • Uncoated and coated (including enteric coating)
      • Hard gelatin capsules (powders, pellets)
      • 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.

  • Commercial Packaging

    Product Commercial Packaging

    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

  • Commercial Storage and Distribution

    Product Commercial Storage and Distribution

    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.

  • Peptide and Protein Technology

    Product Peptide and Protein Technology

    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 .

  • Pharmaceutical Development - Early Phase

    Product Pharmaceutical Development - Early Phase

    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.

  • Pharmaceutical Development - Late Phase

    Product Pharmaceutical Development - Late Phase

    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:

  • Immediate and modified release capsules
  • Immediate and modified release tablets
  • Fixed dose combinations
  • Powder / granule filled sachets

  • When developing modified release dosage forms, we often employ one of the following approaches to achieve the desired release profile:
    - Matrix Systems
    - Coating Systems

    Our manufacturing technologies and processing scales range from hundreds of grams for small-scale process investigation studies to hundreds of kilograms for phase III/IV and registration batches.

    We understand that the best way to ensure a smooth regulatory review process for an NDA or MAA is to clearly present the results from a well-defined series of experiments. By understanding the parameters that are critical to the quality of the product and the safety of the patient, we build quality into the product from the start, implementing effective control strategies.

  • Pharmaceutical Product Launch and Distribution

    Product Pharmaceutical Product Launch and Distribution

    Pharmaceutical Product Launch and Distribution
    Having successfully partnered in the launch of 15 significant orphan and niche drug products into the EU market over the last 3 years, Almac is the industry leader for Pharmaceutical Product Launch and Distribution.

    The European marketplace presents a variety of challenges, from numerous official working languages to complex regulatory frameworks. With the knowledge and expertise of our professional Product Supply Managers, we can ensure your pharmaceutical product launch runs smoothly.

    We have supported many of the industry’s recent first in class, innovative orphan drug launches in areas such as Cystic Fibrosis, Muscular Dystrophy, Hemolysis and Short Bowel Syndrome.

    Our Dedicated Product Supply Team
    Our dedicated product supply team are experts in navigating market requirements and supporting client partners to successfully launch their orphan / niche drug products. They have extensive practical experience of launching pharmaceutical products into the marketplace and manage a multidisciplinary project team in quality, packaging design, regulatory and distribution, ensuring milestones are met and that your market entry strategy is successful.

    Our Services
    In our experience, it’s never too early to start to think about your pharmaceutical product launch. We take pride in our ability to support our clients with varying time frames, from as far as 24 months before submission of their MAA to those with shorter time frames, post submission.

    Having successfully supported the pharmaceutical product launch of 15 high value niche and orphan drugs over the past three years, we can provide expert guidance on launch strategy and offer the following tailored solutions:

    - Named Patient Supply and Early Access Programs
    - EU Import Testing and QP Release
    - Regionalised Packaging
    - Order and Financial Management
    - End-User Distribution

    The Almac TouchTM: By integrating all of your pharmaceutical and distribution needs for your pharmaceutical product launch into a single supply team, you will minimise your effort and maximise your return

  • Preformulation & Solid State Services

    Product Preformulation & Solid State Services

    Almac’s Physical Sciences groups’ comprehensive range of services and expertise will help strengthen the success of your product.

    Identifying and consistently producing a drug in its optimal physical form is vital to any successful drug development programme. It also avoids the need for bridging toxicological or pharmacokinetic studies or the need to implement expensive form control strategies at short notice.

    Through the creation of synergy between solid-state chemistry and formulation development, our experienced scientists have the ability to add great value to your pre-clinical project, while decreasing timelines.

    Our investigations are driven by science, not robotics with highly trained chemists and analysts directing every study.  We have delivered screening, troubleshooting and analysis solutions for over 100 virtual, biotech and large Pharma clients, thus contributing to the success of many drug development programmes.

  • Serialisation

    Product Serialisation

    Serialisation and Track & Trace
    Addressing evolving global serialisation legislation, Almac’s expert multi-disciplinary serialisation team lead the way in supporting clients in developing their serialisation strategies to GS1 standards.

    Our Experience
    Almac have over 7 years’ experience in developing and delivering serialisation solutions to secure our clients supply chains.  Our product serialisation software was designed by our own IS team, enabling us to provide a flexible and adaptable solution to readily meet individual market / client requirements.

    Our Solutions
    Tackling counterfeiting and facilitating traceability throughout the product supply chain; from our EU and US commercial packaging facilities we offer:
    - Serialisation strategy consultative services
    - Design, review & generation of new artwork
    - Technical / prototype testing artwork
    - Flexible serialisation / track & trace solutions for all pack formats artwork
    - Serialisation to 3 levels of aggregation
    - Integration with external providers to support serialisation management and Government reporting as required

    With EU and FDA approved commercial manufacturing and packaging facilities we are able to provide end to end solutions for your drug product, helping you meet commercial supply timelines, mitigate risk and reduce overall product costs whilst helping to secure your supply chain.
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