Biological Manufacturing

RecipharmCobra Biologics is the specialist biologics division of the Recipharm AB group, one of the leading contract development and manufacturing organisations in Europe. We provide a comprehensive range of services, from early-stage development to the supply of GMP material for Phase I, II, and III clinical trials. We are with you every step of the way.

The Market Is Growing — So Are We

We have provided contract development and manufacturing services to customers worldwide for more than a decade, and now Recipharm has expanded its biologics capabilities to include two development and GMP facilities in Södertälje, Sweden and Keele, UK. With this expansion of capacity and expertise, we are able to offer extensive services to the growing biopharmaceutical market.

One-Stop Shopping or Stand-Alone Services

RecipharmCobra’s services include cell line development, analytical and process development, and GMP production for recombinant proteins, monoclonal antibodies, DNA, viruses, and cell products. This, with fill finish and formulation capabilities, provides customers with true one-stop shopping for their biologics outsourcing needs. We also offer stand-alone analytical services, including assay development, qualification and validation, cell-based potency assays, product characterisation, product release testing, and stability testing in accordance with ICH guidelines.

We Provide the Latest Technology…

We understand the importance of speed to clinic and have developed platform processes and expertise in key expression technologies, which help our customers reach their critical development milestones. RecipharmCobra has developed a range of proprietary technologies to benefit our customers’ projects including ORT, a method for producing plasmid DNA without antibiotics, antibiotic resistance genes, or any other selectable marker genes.

RecipharmCobra is also pleased to offer the maxXpress service, which combines the power of UCOE technology with the experience and expertise of RecipharmCobra’s cell line development team.

…And First-Class Service

By working closely with our customers, we design a development program that ensures critical milestones and strategic targets are achieved. Our team of scientists are experienced in the development and GMP production of biopharmaceuticals and provide ongoing scientific and regulatory support. Our expertise and state-of-the-art equipment enable us to design processes for early-stage clinical supply through to large-scale manufacture.

RecipharmCobra has a proven track record of delivery. For more than a decade, we have worked successfully with our customers to take projects through early-stage development and into clinical trials. In 2008 we received the VIE Award (Vaccine Industry Excellence) for best contract manufacturing organisation. Our mission as part of the Recipharm group is to be acknowledged as the best-in-class provider of contract manufacturing and development services in the biopharmaceutical industry.

The Recipharm AB Group

Recipharm AB is a leading contract development and manufacturing organisation based in Sweden with 2,000 employees. The company operates 11 development and manufacturing facilities in Sweden, France, the UK, and Germany and is headquartered near Stockholm. We supply the global pharmaceuticals market with hundreds of different products in most dosage forms, including solid dose, granulates, powders, sterile liquids and lyophilisates, semisolids, beta-lactams, hormones, and inhalers.

About the Author

Author Details
Simon Saxby is vice president, Biologics, and is located at RecipharmCobra’s Keele facility, Stephenson Building, Science Park, Keele, Staffordshire ST5 5SP, UK; 44-1782-714181; [email protected], www.recipharmcobrabio.com.