Author Archives: BPI Contributor

Additions to the MAS-100® Product Line of Microbial Air Samplers Deliver Improved Functionality for Pharmaceutical Manufacturers

EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, today announced three additions to its MAS-100® product family. The MAS-100 Iso MH® and MAS-100 Iso NT® systems were developed for use in isolators and enable sampling at critical control points. The distinguishing feature of the MAS-100 Iso MH® system is its four sampling heads, which allow for increased monitoring capacity compared to single-head systems. The compact and easy-to-handle design of the MAS-100 VF® air sampler makes it well-suited for use in controlled environments. The…

Finesse Solutions Introduces SmartLounge at Achema

Finesse will introduce an interactive exhibit called SmartLounge at Achema 2015.  Come visit us at Booth B80 Hall 4.1 for a fun and educational experience.  Visitors will have the opportunity to build a model biomanufacturing process using representative parts on an interactive light table.  On-site experts can then suggest which automation solutions best suit their needs.  Whether an end-user with general questions about our TruBio® software and G3 Universal Controllers or an automation expert looking to do a plant-wide integration…

Goodwin Biotechnology and Aspyrian Therapeutics Collaborate on the Successful GMP Manufacturing and IND Submission for a Novel Antibody Drug Conjugate (ADC) Platform

Goodwin Biotechnology, Inc., a biological contract development and manufacturing organization (CDMO) that specializes in bioprocess development and GMP manufacturing of biopharmaceuticals utilizing mammalian cell culture expression systems and bioconjugation technologies, has partnered with Aspyrian Therapeutics to successfully complete process development, scale-up, and cGMP manufacturing of their novel antibody drug conjugate (ADC). Based on achieving this critical milestone, Aspyrian Therapeutics recently submitted and has received FDA’s acceptance of an Investigational New Drug (IND) Application for RM-1929, their first-in-class, precision targeted therapy…

Vetter Development Service Chicago Completes Recent On-Site Expansion Activities

Vetter, a leading contract development and manufacturing organization (CDMO) that specializes in aseptic filling, has announced today that a number of activities undertaken at its Skokie facility to satisfy existing and ever-increasing future customer demands have been completed. The initiatives include an additional staff shift for daily clinical manufacturing operations, as well as the doubling of capacities for performing visual inspection and in-process control (IPC). The facility also expanded its on-site offerings by giving customers the option to obtain secondary…

Enzo Life Sciences Launches Human Growth Hormone ELISA Kit

Human Growth Hormone (HGH) is produced by the pituitary gland to fuel childhood growth and help maintain tissues and organs throughout life. Human growth hormone initiates a wide variety of growth promoting pathways. The broad spectrum of tissues impacted by HGH lead to its use in the treatment of diverse conditions including growth disorders, obesity, bone disease, diabetes, cardiovascular disease, memory/cognitive disorders and diseases of aging. The anabolic effects of HGH have resulted in its use and abuse by athletes.…

Secondary Packaging: Creating Value with Product Lifecycle Management

This webcast features: Daniela Guttmann, Product and Service Manager at Vetter, and Susanne Hall, Team Leader of Secondary Packaging at Vetter. Factors such as new regulatory requirements (e.g. serialization) and expenses associated with secondary packaging have created significant interest in Product Lifecycle Management (PLM). When incorporated early in the planning process, PLM can boost a product’s chance for success by helping to meet market requirements, and save costs. Watch the webcast on PLM for Secondary Packaging, and learn how it…

Anti-Ebola MVA Vaccine Produced on ProBioGen’s Avian AGE1.CR® Cell Line Platform in Clinical Trials

Complex biologics development and manufacturing specialist ProBioGen today announced that an investigational vaccine against Ebola virus disease, produced on its proprietary, continuous muscovy duck AGE1.CR.pIX® cell line, has proceeded into clinical trials at the Jenner Institute, Oxford University, UK. The vaccine candidate, a modified vaccinia Ankara (MVA) Ebola Zaire vaccine (MVA EBOZ) was produced by Emergent BioSolutions at a 200 L scale to supply the Phase 1 clinical trial. Professor Adrian Hill, Director from Oxford’s Jenner Institute commented: “Production of…

EMD Millipore Introduces Compaction Technology to Improve Solubility and Facilitate Handling of Cell Culture Media Used in Biopharmaceutical Production

EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, today introduced a new technology that compacts dry powder cell culture media into granules, accelerating solubility and improving flowability and handling. The compacted media are therefore more convenient to use, allowing biopharmaceutical manufacturers to further optimize their upstream processes. The technology is water- and additive-free and applies compression force to EMD Millipore’s highly homogenous dry powder media, fixing that homogeneity in place and creating granules several millimeters in…

The Path to Genderless Connectors: How Genderless Connectors Lead to More Flexibility, Faster Changeovers and Reduced Costs

Genderless sterile connectors — with their ability to interconnect with each other without male/female limitations — can enhance the flexibility of single-use systems in a wide range of bioprocessing applications. Genderless connectors reduce system complexity, which in turn lowers requirements for inventory management, simplifies operator training and reduces misconnections in the manufacturing suite. In fact, it’s possible this new connector design will drive industry change similar to the transition from stainless, reusable systems to single-use. How can something as small…

EMD Millipore Launches Cellvento® CHO Cell Culture Media Platform for Optimized Cell Growth and Productivity

EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, today announced the launch of its CellventoTM CHO platform of cell culture media and companion feed formulations for batch, fed-batch and perfusion applications. Available in liquid and powder form, the chemically defined, non-animal-origin media deliver superior cell growth and productivity for various CHO cell types used in biopharmaceutical development and manufacturing. The CellventoTM CHO platform includes cell line and process-specific media and feed compositions, allowing selection of the optimal…