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Merck Expands Production Know-how to Deliver Full End-to-End Solution for Biopharma Industry

Merck KGaA, Darmstadt, Germany

Flexible factory concept allows accelerated drug development and delivery to market, End-to-end solution available globally to help solve customer challenges

2 May 2016
Alex Waite
Editorial Assistant

Industry news

Merck, a leading science and technology company, has announced the expansion of its state-of-the-art single use current good manufacturing process (cGMP) facility with the addition of the Mobius 2000L single-use bioreactor.

With the new upstream suite at its Biodevelopment Center in France, Merck can now offer clients full process line cGMP manufacturing, comprised of Merck's own instrumentation and products.

"Our aim is to facilitate accelerated drug development and delivery via continued innovation and technical expertise by offering customers a complete end-to-end solution from clone to commercial production," said Udit Batra, CEO, Life Science at Merck. "Our unique offering gives customers the choice to transfer their production at any stage with the confidence that we will ensure the most efficient transition into commercial manufacturing - at either an existing facility or one we help them design."

With this increase in scale and scope, Merck can advance clients' recombinant products from cell line development through to late-stage clinical production. At the point of tech transfer out to a contract manufacturing organization or other facility, clients can also leverage Merck's Provantage® End-to-End Services available worldwide to mitigate the risks traditionally associated with upscaling to commercial production.

Merck's Provantage® End-to-End solution is a comprehensive suite of products and services that include process development, cGMP manufacturing, facility design, manufacturing equipment and consumables, process and equipment training, technology transfer and set-up for commercialization. The offering aims to minimize the risks for customers progressing from early clinical stages to commercial production helping to accelerate time to market and improve productivity and profitability.

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Merck KGaA, Darmstadt, GermanyCompany website

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Sample PreparationSample preparation can improve the quality and speed of separation techniques. Products to assist sample preparation include filtration equipment, evaporators, membranes and sieves.Combinatorial ChemistryCombinatorial chemistry, also known as combichem, is a technique used in drug discovery to create libraries of structurally related compounds. A library is generated by synthesis with a chemical reactor system or by computer-based modeling of compound combinations. When undertaking combinatorial chemistry consider reagents, buffers, resins and standards.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.Assay AssemblyAssay Assembly is technique used in drug discovery to develop assays to test the cytotoxicity, genotoxicity, or other activities of a compound on a cell. Assay assembly requires chip assembly, a delivery system and a detection and analysis method. Beneficial features of assay kits or automated systems include high-throughput, high speed and sensitivity and low signal to noise ratio.Process ChemistryProcess chemistry is an important stage of drug development for scaling-up drug production or chemical synthesis reactions. It is useful for optimizing economical and efficient drug production. Process chemistry uses reactors and pump systems as well as reagents, standards and buffers.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Discovery SoftwareComputational techniques used in both the chemistry and biology aspects of drug discovery, for data acquisition, processing and storage. Software is used for analysis of pathways, target identification, genomics, proteomics, modelling, lead identification, compound analysis and drug modelling among many others. Compound AnalysisCompound analysis is used to discover specific compounds that could be promising candidates for pharmaceutical use. This potential is identified when compounds have the desired effect, such as interaction with a target protein, during high throughput screening.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Bioprocessing / FermentationBioprocessing is the use of biological materials to perform commercial, scientific or medical research processes. Biological materials used include cells, enzymes and organisms. Usually bioprocessing requires a batch or continuous bioreactor such as a fermentor or cell culture system. The advantages of using a reactor include high productivity, easy configuration, adjustable values and automation.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.BiotechnologyBiotechnology is the use of biological processes, organisms, or systems in the production of products and services. It spans a wide range of applications, including healthcare, agriculture, and environmental management. Browse our peer-reviewed product directory to find the best biotechnology tools, compare products, check reviews, and get pricing directly from manufacturers.Drug MetabolismDrug metabolism is the enzymatic conversion within the body of pharmaceutical substances into other chemical compounds. The primary site for drug metabolism is the liver.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.

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Merck Expands Production Know-how to Deliver Full End-to-End Solution for Biopharma Industry