Author Archives: BPI Contributor

Quantum ReNu SU Technology® Validation Guide and Performance Testing Summary

As the use of disposable systems within biopharmaceutical manufacturing has moved from niche preclinical applications to large scale commercial processes. This has led to the requirement for novel technologies that improve processing throughput and allow manufacturers to increase their output. To this end, WMFTG has developed a new pumping technology to enable end-users to meet their downstream processing needs for unit operations such as chromatography and tangential flow filtration (TFF). Quantum allows end-users to use novel peristaltic technology for their…

Achieving Continuous Downstream Bioprocessing Through Multi-Column Chromatography (MCC)

In recent years, improving downstream manufacturing has become an emerging challenge to the biopharmaceutical industry. Initially, the bottleneck in biopharmaceutical manufacturing existed in the output of bioreactors. Due to advances in cell line development and upstream process (i.e., perfusion), the output of bioreactors has increased at a much faster pace than downstream processing capacity. Therapeutic biologics, including monoclonal antibodies (mAbs), represent the fastest growing segment of the pharmaceutical market. By 2019, the biological market is expected to exceed 20% of…

BIOne – Single-Use Bioreactor System

Convert your existing benchtop glass bioreactor to a single-use bioreactor in seconds. Distek, Inc. has developed a benchtop scale single-use bioreactor (SUB) system for mammalian cell growth and recombinant protein production. The pre-sterilized BIOne system is engineered with a disposable headplate welded to a triple-layered liner that can be easily inserted into a non-sterile bioreactor glass vessel, converting it to a sterile, disposable SUB within a matter of seconds. Simply remove your existing headplate and place the preassembled and irradiated…

Continuous Processing Optimization With Smarter Tools

Single-use technology (SUT) has long been viewed as a viable solution to today’s biopharmaceutical manufacturing challenges. It offers the flexibility to change a production configuration to meet demand while also offering many other cost benefits, such as savings related to the elimination of clean-in-place (CIP) and sterilization-in-place (SIP) processes. However, traditional and fed-batch models fail when trying to adapt to single-use flexibility due to the required rewriting of code and revalidation. The best way to use the flexibility of single-use…

Impact of Single-Use Tangential Flow Filtration in Downstream Bioprocessing

This webcast features: Michael LaBreck, Sales Director, Repligen TagenX Products Single-use solutions are fast becoming platform in bioprocessing as a response to pressure to optimize process economics and process efficiencies. Implementing single-use alternatives in tangential flow filtration (TFF), a critical step in downstream bioprocessing for concentration and diafiltration (buffer exchange), is a major part of this transformation. Repligen TangenX™ SIUS™ Single-use Cassettes are the first purpose-built cassettes designed for tangential flow filtration. This webinar will demonstrate how deploying these innovative…

MilliporeSigma Launches Industry’s First Off-the-Shelf Cell Culture Media for Perfusion Processes

MilliporeSigma, today took a significant step toward increasing manufacturing flexibility and enabling higher productivity with the launch of the EX-CELL® Advanced™ HD Perfusion Medium. This first off-the-shelf, high-density cell culture media supports perfusion processes and facilitates high productivity at low perfusion rates, increasing production yield and speed to clinic. Biomanufacturers are moving toward perfusion processes, the next generation in manufacturing, as they seek to cut costs while increasing quality and efficiency. Perfusion processes, however, require a new type of medium…

JSR Life Sciences Expands Amsphere™ A3 Production Capacity

JSR Life Sciences (JLS), the global life sciences focused division of JSR Corporation, today announced plans for expansion of its production capabilities of Amsphere™ A3 protein-A chromatography resin at JSR’s Belgium subsidiary, JSR Micro NV. This expansion will effectively increase its production capacity by six times and provide redundancy in its manufacturing capability. JLS’s Amsphere™ A3 has experienced rapid adoption as an alkali-stable, high-capacity alternative option for downstream purification in the biopharmaceutical industry since its launch in January 2016. Based…

Sartorius Stedim Biotech Introduces New BIOSTAT STR® Bioreactor Range

Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, announced the launch of its next generation BIOSTAT STR®, a fully scalable, single-use bioreactor family based on a conventional stirred-tank design. This new bioreactor range featuring upgraded hardware and software, as well as a fully integrated, new design of Flexsafe STR® single-use bags, ensures quick and easy bioprocess scale-up of biologics and vaccines. The BIOSTAT STR® bioreactors are equipped with an improved stainless steel bag holder for user…

Charter Medical Announces Exclusive Global Distribution Agreement with INCELL Corporation

Charter Medical Ltd., a Fenner PLC subsidiary (LSE:FENR), a globally recognized manufacturer of products for the regenerative medicine and bioprocessing industries, announced today that it has established a strategic partnership with INCELL Corporation, an innovative developer and manufacturer of specialty medias and formulated solutions for tissue and cell collection, transport, processing and storage. The partnership will enable both organizations to meet the growing customer demand for more comprehensive solutions in cell culture, cell expansion, and cryopreservation. Mary Pat Moyer, Founder,…

Sartorius Stedim Biotech Launches Chemistry Testing Services

Sartorius Stedim Biotech (SSB) announced the launch of a full range of chemistry testing services. Offered by its subsidiary Sartorius Stedim BioOutsource, they characterize the physicochemical properties and structural attributes of therapeutic monoclonal antibodies (MAbs). The service platform methods have been developed to ensure rapid sample analysis and reporting for MAbs and biosimilars. This comprehensive range of chemistry testing services complies with the well-established ICH Q6B scientific guidelines for pharmaceuticals for human use, and includes methods to characterize protein structure,…