Author Archives: Leah Rosin

Enzo Life Sciences Launches New PLAQPRO™ Lp-PLA2 Assay to Measure Cardiac Risk

Enzo Life Sciences is proud to introduce our new assay, PLAQPRO™ Lp-PLA2 Assay, measuring the activity of Lp-PLA2 in vitro.  Lp-PLA2 is produced by inflammatory cells and circulates primarily bound to LDL. The oxidization of LDL is an early key event in the pathogenesis of atherosclerosis. Increased levels of Lp-PLA2 have been found in atherosclerotic plaques and rupture lesions. The PLAQPRO™ Lp-PLA2 Assay is a colorimetric readout assay that measures the activity of Lp-PLA2 in serum samples. Our assay represents a cost-efficient alternative to…

Distek, Inc. Awarded U.S. Patent for Multi-Motion Assembly Design

Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry, as well as an experienced provider of validation and qualification services, has been awarded U.S. Patent 9,333,469 for their multi-motion assembly design. Distek’s patented, multi-motion assembly design, also known as D-Drive, allows for one assembly mechanism to provide both linear and rotational motion. This D-Drive technology, found on the symphony 7100 “Bathless” Dissolution Instrument, can raise and lower the shafts at various speeds as well…

MilliporeSigma Builds on Leading Viral and Gene Therapy Service Offering with Capacity Expansion

MilliporeSigma today announced an expansion of its Carlsbad, California facility to meet growing demand for viral and gene therapy products. Scheduled for completion in 2016, the Carlsbad campus will increase from 44,000 square feet to 65,000 square feet, with 16 modular viral bulk manufacturing cleanroom suites, two fill/finish suites and twice the warehouse capacity. The expansion will incorporate single-use equipment in a flexible, scalable format for clinical and commercial bulk drug production. “We are building on our industry-leading offerings in the…

Lonza and Renova Therapeutics Announce Manufacturing Agreement for Clinical Supply of RT-100 Gene Therapy

Lonza Houston, Inc., a global leader in viral gene therapy manufacturing, and Renova™ Therapeutics, a biopharmaceutical company developing gene therapy treatments for congestive heart failure and other chronic diseases, have entered into a Manufacturing Services Agreement to develop a scalable manufacturing process and produce cGMP-grade RT-100 (Ad5.hAC6) Drug Product for use in Renova’s future clinical trials. This relationship will leverage Lonza’s expertise for the development of a cost-effective, scalable and robust suspension culture-based adenovirus manufacturing platform, which is anticipated to…

Defining Your Product Profile and Maintaining Control Over It | A Look Back with Emily Shacter

This is a transcript from a Q&A interview with Emily Shacter, PhD, Consultant, ThinkFDA LLC (former FDA Scientist and Regulator). We will be talking today about the CMC Forum that was published back in 2005. We are revisiting it in the magazine to specifically update our understanding of how to maintain process control; understanding your process. In general, how do you feel the discussions in the four-part paper from 2005 has held up after 10 years? Emily: I think they…

Introducing Novo Nordisk Pharmatech: A Rebranding Initiative Transforms the Former FEF Chemicals

In June of this year, Leah Rosin, BPI’s marketing and digital content strategist, spoke with Rasmus Hother Le Fevre, managing director and corporate vice president, Novo Nordisk Pharmatech A/S (formerly FeF Chemicals A/S), about the company’s rebranding initiative. She began by asking him about the company’s history and reason for the name change to Novo Nordisk Pharmatech A/S. Le Fevre: Novo Nordisk Pharmatech was established in 1949 as FeF Chemicals, acquired by Novo Nordisk in 1986, and has been part…

Pall Acquires BioSMB Platform from Tarpon Biosystems

Pall Corporation announced today that it has acquired the BioSMB technology platform from Tarpon Biosystems. The addition of Tarpon’s cutting-edge technology with Pall’s engineering capabilities and innovative single use technologies will accelerate the adoption of continuous downstream processing into biopharmaceutical manufacturing. The BioSMB chromatographic systems enable single use, multi-column chromatography for process development and are well placed for multi-product and single use facilities. The addition of the BioSMB technology expands Pall’s portfolio in continuous processing technology at both the process…

Novasep Selected for Commercial Biomanufacturing of Celladon’s Mydicar API

Novasep, a leading supplier of services and technologies for the life sciences industry, today announces that it has entered into an agreement with Celladon, a clinical-stage biotechnology company, to prepare the supply of the drug substance for MYDICAR®. The €4.7M deal covers scale-up and pre-validation studies as well as facility enhancement engineering Novasep will make at its Seneffe (Belgium) bioproduction plant to enable it to bring advanced heart failure drug MYDICAR into commercial production. In addition, Novasep and Celladon have…