Leah Rosin
- Marketing and Digital Content Strategist, BioProcess International Magazine
- Head, Digital Content Delivery, Informa Connect
Eugene
A PNW farm girl turned digital content strategist in the biopharma space. Former IT & biotech editor. Insatiable volunteer. Proud mama of a 5th grader. She/her
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Articles by Leah Rosin
Unique territorial and compartmental organization of chromosomes in the holocentric silkmoth
Abstract The hallmarks of chromosome organization in multicellular eukaryotes are chromosome territories (CT), chromatin compartments, and insulated domains, including topologically associated domains (TADs). Yet, most of these elements of chromosome organization are derived from analyses of a limited set of model organisms, while large eukaryotic groups, including insects, remain mostly unexplored.
Unique territorial and sub-chromosomal organization revealed in the holocentric moth Bombyx mori
Abstract The hallmarks of chromosome organization in multicellular eukaryotes are chromosome territories (CT), chromatin compartments, and different types of domains, including topologically associated domains (TADs). Yet, most of these concepts derive from analyses of organisms with monocentric chromosomes. Here we describe the 3D genome architecture of an organism with holocentric chromosomes, the silkworm Bombyx mori. At the genome-wide scale, B.
Single-Use Technology in Upstream Processing: A Roundtable Discussion - BioProcess International
The Sartorius upstream portfolio addresses key strategic challenges facing the biopharmaceutical industry: Increased speed to clinic/market and lowered capital costs, with improved process control. Fully scalable, proven process solutions for cell line, media, and process development through commercial manufacturing accelerate upstream development and simplify manufacturing.
Multi-Product Facility Realized by Modular Automation Platform - BioProcess International
This webcast features: Dr. Burkhard Joksch, Product Manager, Bioprocess Automation at Sartorius Stedim Biotech GmbH, and Dr. Stuart Tindal, Product Manager, FlexAct® Platform at Sartorius Stedim Biotech GmbH Multi-product facilities need modular package units to realize fast change-over without reducing product quality and process performance.
Development of a Standardized Extractables Approach for Single-Use Components: General Considerations and Practical Aspects — A Manufacturer's Perspective - BioProcess International
The subject of extractables for single-use bioprocess contact materials has been a subject of heated debate since roughly the summer of 2012, when the first ISPE paper was published issuing a call to action to develop a standardized extractables protocol for the industry (1).
Industry Innovators - BioProcess International
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Advantages of Fluoropolymer Single-Use Systems - BioProcess International
This webcast features: Eric Isberg, Director of Life Sciences, Entegris There remain significant performance risks restricting the use of disposables in bioprocessing. These factors include bag breakage, which is particularly evident in cold temperature applications; concerns around E&L and material purity; and use of materials which are incompatible with the process itself.
Developing a Whole Genome CRISPR Screen to Improve CHO Cells for Biomanufacturing - BioProcess International
This webcast features: Jaime Freeman, PhD, Product Manager, Horizon Discovery While great strides have been made in increasing the yield of biotherapeutic proteins, these have been achieved mainly through process improvement with a particular focus on media and feed strategies. Aside from single gene knockouts to allow for metabolic selection systems, the CHO host itself remains largely unchanged from that which was used thirty years ago.
test for error - BioProcess International
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TEST - BioProcess International
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Addressing Quality in Cell-Line Development: Direct Analysis of Bioreactor Harvest for Clone Selection and Process Optimization - BioProcess International
Therapeutic monoclonal antibodies mostly are manufactured using mammalian cells cultured in a bioreactor for two to three weeks. Often the bioreactor harvest is considered too “dirty” to be tested with any analytical method. We explored direct analysis of bioreactor harvest using capillary sodium-dodecyl sulfate (cSDS) electrophoresis, size-exclusion high-performance liquid chromatography (SE-HPLC), and surface plasmon resonance (SPR) assays.
Bioanalytical Contract Testing Customer Service Frost & Sullivan Award Given to Sartorius Stedim BiotechBioProcess International
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, received the prestigious Frost & Sullivan’s 2017 European Customer Service Leadership Award for Bioanalytical Contract Testing Services. Presented at the Frost & Sullivan ceremony yesterday evening in London, UK, this award recognizes the unique product and service combination and enhanced customer satisfaction provided by Sartorius Stedim BioOutsource, SSB’s subsidiary based in Glasgow.
PCT Establishes Global Contract Development and Manufacturing Services Platform with Opening of Yokohama, Japan Facility
Hitachi Chemical Co., Ltd. (HCC), a global service provider for the cell therapy industry through its PCT development and manufacturing service platform, today announced the completion of construction and opening of its Yokohama, Japan facility on October 11.
The Eclipse 5300 Dissolution Sampler Receives CE, ETL and FCC Mark Approval
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.
testx - BioProcess InternationalBioProcess International
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Selexis Announces Commercial License Agreement with Takeda for the Development of Fusion Proteins
Selexis SA, a pioneering life sciences company and a global leader in mammalian cell line generation technology, announced today that it has entered a commercial license agreement (CLA) that provides Takeda Pharmaceutical Company Limited [TSE:4502], (“Takeda”) with access to high-performance research cell banks (RCBs) developed using the Selexis SUREtechnology Platform™. Takeda is leveraging Selexis’ mammalian cell line-based protein expression platform to develop recombinant fusion proteins.
AdvantaPure Launches AdvantaSil™ Brand of Silicone Tubing and Hose
AdvantaSil silicone tubing and hose products are quickly becoming recognized as superior products for Single-Use processes worldwide. Engineers in process development and manufacturing have relied on AdvantaSil products for years for unreinforced tubing, reinforced hose, pump grade tubing and wire reinforced suction hose. The products are designed and tested for the biopharm and pharmaceutical industries and are used for food, beverage, laboratory and chemical transfer applications as well.
Distek, Inc. Releases Eclipse 5300 Automated Dissolution Sampler
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, announced today the release of the Eclipse 5300 automated dissolution sampler. The Eclipse 5300 Automated Dissolution Sampler by Distek offers rapid and accurate sampling using precision syringes.
MaSTherCell to Develop CAR-T Cell Therapy for ServierBioProcess International
Servier, the independent international pharmaceutical company, and MaSTherCell SA, the full-service contract development and manufacturing organization (CDMO) specializing in the delivery of optimized process industrialization capacities to cell therapy organizations, today announced the signing of a master service agreement for the development of a manufacturing platform for allogeneic cell therapies.
Sartorius Stedim Biotech Opens New Bioanalytical Testing Laboratory in Boston
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, opened a new bioanalytical and biosafety testing laboratory yesterday in the major biotech hub of Boston, Massachusetts. This dedicated bioanalytical laboratory is designed to accommodate the rising demand for the company’s BioOutsource brand specialized assay platforms in North America and facilitate the ongoing expansion of this unique service offering.
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-PLA Assay, measuring the activity of Lp-PLA in vitro. Lp-PLA 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-PLA have been found in atherosclerotic plaques and rupture lesions. The PLAQPRO™ Lp-PLA Assay is a colorimetric readout assay that measures the activity of Lp-PLA in serum samples.
MilliporeSigma Launches Viresolve® Pro Shield H for More Robust, Economical Parvovirus Removal
MilliporeSigma today launched the Viresolve® Pro Shield H for removal of parvoviruses from therapeutic protein feed streams. The new Viresolve® Pro Shield H is designed for use as a prefilter with Viresolve® Pro Devices for more robust, cost-economic viral clearance. Viresolve® Pro Shield H removes protein aggregates and impurities that foul virus filters in high pH and high conductivity monoclonal antibody (MAb) feed streams.
MilliporeSigma Developing Next-Generation Vaccine Purification with IVIBioProcess International
MilliporeSigma has entered a research agreement with the International Vaccine Institute (IVI) of Seoul, South Korea to help develop more robust, scalable vaccine manufacturing processes. MilliporeSigma will provide funding and expertise in the areas of clarification and purification. The IVI is a nonprofit international organization committed to the discovery, development and delivery of safe, effective and affordable vaccines for global public health.
Distek, Inc. Releases BIOne Single-Use Bioreactor System
From the company that has brought you 40 years of excellence in laboratory pharmaceutical instruments, Distek, Inc. is proud to introduce the BIOne (pronounced “BIO One”) Single-Use Bioreactor System. Distek, Inc. has developed a benchtop scale single-use bioreactor (SUB) system for mammalian cell growth and recombinant protein production.
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.
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.
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, 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 have held up well.
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