Company Category: Tumor Markers

Almac Diagnostic Services We are a precision medicine company specialising in biomarker driven clinical trials. Our global CLIA and CAP accredited laboratories cover UK, Europe, USA and APAC regions. Our cores services: * Multi-Omic Services: We offer a range of genomic & proteomic platform and chemistry options, alongside expert data sciences support & a specialty central lab service. * Clinical Biomarker & CDx Development: Custom Clinical Biomarker & CDx development, validation & delivery service from our CLIA & CAP accredited laboratories in USA, Europe and APAC. * Clinical Testing: Global clinical trial testing service from our clinical laboratories, including a menu of platforms & assays and an integrated specimen collection & logistics service. Find Out More www.almacgroup.com/diagnostics | The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Operating from state-of-the-art facilities in the US, Europe, and the UK, Almac Pharma Services is a FDA, HPRA, and MHRA approved CDMO partnering with global pharmaceutical and biotechnology industries. We have over 50 years’ experience in providing a comprehensive range of tailored solutions. Almac possesses a wealth of technical expertise to support the delivery of your complex projects. Our scientists can develop your clinical candidate into an optimum formulation, and solid manufacture oral dose products for all stages of clinical trials. Almac’s integrated pharmaceutical development solutions are tailored to meet your needs. We specialise in the manufacture & primary packaging of solid, oral dosage forms (Tablets, Capsules and Powders). As well as customised secondary packaging for all drug products including ultra-low temperature drug products. Almac works in close partnership with our clients offering unique solutions designed to support the efficient and successful development, and commercialisation of new treatment options. | Operating from state-of-the-art facilities in the US, Europe, and the UK, Almac Pharma Services is a FDA, HPRA, and MHRA approved CDMO partnering with global pharmaceutical and biotechnology industries. We have over 50 years’ experience in providing a comprehensive range of tailored solutions. Providing end-to-end integrated solutions to bring your drug product from development through to commercialisation from a single source. We work with clients to provide pharmaceutical development, manufacturing, product launch, and packaging solutions to fit their unique needs. Our team of experts can support the development of fit-for-purpose formulation for First-in-Human trials, to developing a more robust formulations scaling up for late phase trials, and ultimately commercialisation. Supporting key development and manufacture areas such as paediatrics, potent and highly potent products. We provide primary and secondary packaging for all drug products including ultra-low temperature drug products and specialised kit assembly. Almac was one of the 1st EU CDMOs to support gene therapy product launches, and currently supports 25% of EU approved/pre-registration Gene Therapy solutions. We provide end-to-end management of drug product supply, including distribution, packaging design, and support initial and ongoing global product launch. We provide unique, tailormade solutions designed to support the efficient and successful development, and commercialisation of new treatment options. Partnering with our clients to provide flexible, stable, ongoing supply to meet their product pipeline needs. | The Almac Group is a global leader in providing a range of expert services and support across the drug development lifecycle. A privately owned organisation, under the McClay Foundation, Almac has grown organically over the past five decades, now employing over 7,500 highly skilled individuals across 18 locations in Europe, the US and Asia. Almac Group is comprised of 5 Business Units: • Almac Diagnostic Services • Almac Sciences • Almac Pharma Services • Almac Clinical Services • Almac Clinical Technologies Each Business Unit offers specialist and dedicated solutions at each phase of the product lifecycle providing the ability to select single or multiple, integrated solutions to meet your unique needs. Our unique combination of inspirational people, exceptional innovation and outstanding quality, enables us to provide tailored solutions for your specific requirements – either on a single, standalone project or on a long-term basis as your strategic partner. About Almac Pharma Services: With over 55 years’ experience, Almac Pharma Services is an established, reliable and world leading outsourcing partner to the global pharmaceutical and biotechnology industry. Employing over 1,800 highly skilled individuals across 4 locations in Europe and the US, we provide a range of tailored, quality-led and timely solutions from early and late phase pharmaceutical development, clinical and commercial drug product manufacture, product launch through to commercial packaging and global distribution. Currently supporting client portfolios across more than 70 countries, our fully integrated, end-to-end solutions are tailored to meet the needs of your unique products, and, ultimately, your patients. Pharmaceutical Development Solutions: Spanning both early and late phase development, our teams of expert scientists possess a wealth of experience in developing clinical candidates into optimal formulations and manufacturing high-quality oral dose products for all phases of clinical trials. Operating both non-GMP and GMP facilities we have complementary equipment trains and integrated technical teams to facilitate technology transfer providing a seamless transition between formulation and process development, and clinical trial material manufacturing. Through a range of flexible and fully tailored unit operations including blending, roller compaction, high shear granulation, encapsulation (including Xcelodose) micro encapsulation and fluid bed processing, we offer the following oral dose formulations with batch sizes ranging from grams to tons: • API / powder in hard gelatin capsules or bottles, including micro-dosing • Formulated blends in hard gelatin capsules or bottles • Tablets (coated) • Mini-tablets • Granules • Beads/pellets • Non-sterile liquid in capsules or bottles • Immediate and modified release • Fixed dose combination products • Potent and highly potent products (OEL as low as 0.05 ug/m3/8 hours) • Specialist paediatric drug development expertise Analytical Solutions: We employ over 700 highly skilled analysts working in state-of-the-art, fully certified GMP laboratories across Europe and the US with significant experience in the analysis of both small and large molecules. We support drug substance (API) and drug product (finished product) analytics across all phases of clinical development through to commercial release. We offer a range of tailored services including: • Method development • Method validation • Method transfer • Stability programmes • Release analysis: all lifecycle stages • Spectroscopy services • Investigational analysis • Reference standard management • Microbiological testing • Physical sciences • Bio-pharmaceutical testing • Analytical support for clinical trial supplies Commercial Manufacture Solutions: Scaling up from our oral dose development assets and expertise through registration and launch into commercial supply, or transferring existing commercial products, we support your commercial manufacturing needs with flexibility and expertise. With blend sizes from 10kgs up to 2.5 tons, our range of state-of-the-art processing equipment is designed to enable scalability to the batch size requirements of your product for a range of presentations including: • Tablets • Mini-tablets • Capsules • Powders • Granules • Beads/pellets • Non-sterile liquids • Potent and highly potent products (OEL as low as 0.05 ug/m3/8 hours) • Specialist paediatric drug manufacturing expertise Commercial Packaging Solutions: Our high and low throughput operations provide the flexibility and efficiency necessary to meet your ongoing and fluctuating demand. Our commercial facilities in Europe and the US, combined with our local expertise offers flexible, quality-led commercial pharmaceutical packaging solutions tailored to meet your specific needs. Our range of primary packaging solutions include: • Tablets • Mini-tablets • Capsules • Powders • Granules • Non-sterile liquid • Our secondary packaging, labelling and assembly capabilities include: • Bottles Vials / ampoules • Pre-filled syringes • Wallets / blister cards • Auto-injectors • Cartons • Sachets • Stick packs • Offline blister printing Innovative, specialist packaging solutions including: • Specialist paediatric drug packaging expertise • Expert cell and gene therapy (ATMP) Ultra Low Temperature (ULT) solutions (-20° to -80°) • Complex medical kit assembly solutions via our unique, custom built semi-automated packaging technology Support Solutions: We provide a wide range of tailored support and consultancy services to help guide you through every aspect of your unique development and commercialisation journey. Find out more – www.almacgroup.com