Author Archives: BPI Contributor

Updated Sustainability Report from NewAge® Industries Showcases Recent Improvements

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Plastic tubing manufacturer NewAge Industries has released the Second Edition of its Sustainability Report focused on continued commitment to corporate social responsibility (CSR). The company made additional improvements to its facility and operations to further its sustainability practices. This Second Edition report highlights recent upgrades such as: The installation of an electric vehicle charging station Energy-efficient LED lighting in all building renovation areas Becoming a zero landfill organization by using enhanced recycling and an EfW, or Energy from Waste, facility…

October 11, 2017

WPI’s Biomanufacturing Education and Training Center 2018 Schedule

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Now is the time to plan professional development for 2018: check out the Biomanufacturing Education and Training Center’s 2018 schedule. Download the flyer and gain access to exclusive discount opportunities for BPI subscribers. About: The Biomanufacturing Education and Training Center at Worcester Polytechnic Institute (BETC) is where biotechnology professionals gain a competitive edge. Our innovative partnership between academia and industry creates customized workforce development solutions for forward-thinking biotechnology companies across the region and around the world. Whether you’re an employee…

October 11, 2017

Rentschler Biotechnologie GmbH Announces Transition into a European Corporation Called Rentschler Biopharma SE

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Rentschler Biotechnologie GmbH, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, today announced that the Company has successfully transitioned into a European corporation (SE) with entry into the German commercial register on October 1, 2017. The Company is operating as Rentschler Biopharma SE with immediate effect. There will be no operational changes for clients or employees of the family-owned company due to the transition. “With our transition to Rentschler Biopharma SE, we emphasize our long-term international corporate identity,…

October 9, 2017

Single-Use Bag Permeability Testing in Cryopreservation Conditions

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This webcast features: Mike Johnson, Business Development Engineering Manager, Life Sciences Puncture strength, haze, Tg, extracts and permeation rates are all single-use bag attributes about which end-users want data. While these are important characteristics, they are polymeric material properties that may or may not indicate actual bag performance. Ultimately, an end-user wants to know that the single-use bag will not put their process fluid at risk. In this study, single-use bags with different gas permeation rates were filled with a…

October 9, 2017

The Eclipse 5300 Dissolution Sampler Receives CE, ETL and FCC Mark Approval

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Distek, Inc., has announced that the Eclipse 5300 Dissolution Sampler has now received CE, ETL and FCC mark approvals. The Eclipse 5300 has undergone certification with an accredited testing laboratory and has passed all the required testing standards for obtaining approval. Placing CE, ETL and FCC Marks on our product shows consumers, specifiers and authorities that our instrument fully complies with these important safety and regulatory standards. The European Commission describes the CE mark as a “passport†that allows manufacturers…

October 4, 2017

Lonza to Acquire a U.S. Clinical Manufacturing Site to Support Ongoing Customer Demand

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Lonza announced today that it is acquiring a clinical-stage mammalian manufacturing site in the United States from Shire plc. Financial details of the deal were not disclosed. The 58,000-square-foot (approximately 5,388-square-meter) site, located in Hayward, CA (USA), has been operating as a multiproduct cGMP facility since 1990 and has a successful regulatory track record. Assets include 1,000L and 2,000L single-use bioreactors and associated downstream capabilities. Currently the site employs more than 100 personnel, all of whom will have the opportunity…

October 3, 2017

How to Overcome Validation Challenges in a Single-Use World

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While the popularity of single-use systems (SUS) is increasing, regulation of SUS supply chains is not. With increased regulatory scrutiny on supply chain security and risk mitigation strategies throughout the development and manufacturing of a therapeutic drug product, end users are scrambling to find ways to ensure the expected level of compliance. The solution? Sharing responsibilities across the entire supply chain. Validation must begin at the component raw material level and continue to final assembly. Primary parties – including drug…

October 3, 2017

Vetter Lays the Foundation for a State-of-the-Art Administration Building

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At a cornerstone ceremony, Vetter officially signaled the start of a project for the creation of a new administration building at its Ravensburg Schuetzenstrasse site. Scheduled to be completed by the middle of 2019, the new building is part of an ongoing investment strategy designed to further develop Vetter sites and make available additional manufacturing capacities. Following its completion, the new building will have a useable area of 25,000 square meters (269,000 square feet). As a modern office building, Vetter…

October 2, 2017

Purification of Antibody Fragments and Single Domain Antibodies With Amsphereâ„¢ A3 Protein A Resin

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The standard capture purification of full-size, classical antibodies is typically performed with Protein A affinity chromatography. Binding of the Protein A affinity ligand to the “Fc†region of antibodies (Abs) (abbreviations are defined at end of paper) takes place at the juncture of the constant domains 2 and 3 of the Ab heavy chains (Lewis et al. 2008). This high affinity binding primarily involves hydrophobic interactions. Antibodies that belong to the same subclass have greater than 95% homologous Fc-regions, allowing…

September 26, 2017

Collaborate to Innovate: Shaping the Future Pharmaceutical Manufacturing Landscape

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As the demand for new life-enhancing therapies increases globally, the pharmaceutical manufacturing community faces an unprecedented challenge to accelerate speed to market. Keeping up to date on industry trends is critical to maintaining a competitive edge. But how do you actively drive these trends and apply them to your manufacturing processes to bring your innovation strategy to life? Whether you are implementing single-use technologies to reduce costs and increase productivity or expanding your operations in emerging markets, scientific collaboration and…

September 21, 2017