Author Archives: BPI Contributor

Setting Up a Rapid Mycoplasma Assay Supporting Recombinant Production

This webcast features: Kent Persson, PhD, Project Manager, Octapharma Octapharma AB in Stockholm, Sweden, is the site for the NUWIQ® production, a recombinant human FVIII produced in human cells. Regulatory guidelines states that recombinant bulk harvest need to be tested for mycoplasma prior to further processing. The presentation will give the overview on a nearly completed journey on replacing an out-sourced mycoplasma test with Thermo Fisher’s MycoSEQ qPCR assay. Octapharma in Stockholm has recently been sought regulatory approval for the…

EZ BioPac® Powder Transfer Gets Your Biologic to Market Faster, with Less Risk

This whitepaper quantifies how one simple change can drastically reduce the time it takes to get biologics manufactured. Getting media and buffer into large-scale, continuous bioprocessing has been burdensome, time consuming and messy. Upgrading to modern single-use powder handling in your process gets your product to market without time wasted on complicated weigh and dispense steps, cleaning validations, or worries about powder in the air and in the room.

The Multi-Mode Mimetic Ligand Library: A New Tool for Rapid Development of Downstream Processes

Recent developments in downstream processing of biomolecules — including continuous processing, bind–elute affinity capture, and flow-through polishing steps — have increased the need for greater selectivity from chromatography adsorbents. This has led to the introduction of a new generation of adsorbents: so-called “mixed-mode” or multimodal ligands. They provide greater selectivity and tolerance to process buffer composition than either ionexchange chromatography (IEC) or hydrophobic-interaction chromatography (HIC) alone can provide. Learn more in this Special Report from Steve Burton, Chief Executive Officer…

Scaling Up? No Problem with New 80cm Diameter Pre-packed OPUS Columns

This webcast features: Fletcher Malcom, Director of Product Management, Downstream Technologies, Repligen The technical and economic benefits of ready-to-use, pre-packed chromatography columns have been proven and documented. The question remains, how large can we go? This presentation will show how the unique design of the new 80cm pre-packed OPUS column delivers chromatographic performance, and how usage can result in substantial cost and time savings for clinical and commercial scale manufacturing. Watch the recorded webcast on-demand.

Removal of Endotoxins – From Bench to Process Scale

Endotoxins or lipopolysaccharides (LPS) are highly toxic components of the cell wall of Gram-negative bacteria, which are often present in significant amounts in bacterial cell expression systems such as E.coli. A number of methods have been adopted for the removal of endotoxin based on adsorption, in particular ion exchange chromatography. Although downstream processing can significantly reduce endotoxin levels in the product, efficient and cost effective removal of residual endotoxin from biopharmaceutical preparations remains a challenge. Prometic Bioseparations have developed an…

Advantages of Fluoropolymer Single-Use Systems

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. Improved plastics are required to meet existing and future process needs; fluoropolymers appear to be very promising to achieve these goals. Fluoropolymers’ unmatched characteristics are inherent to their…

BPI West TV 2018: Dr Joswin Kattoor, Product Manager Pharma, DPL

At BioProcess International West (March 2018) Maribel Rios, Managing Director at BioProcess International, caught up with Dr Joswin Kattoor, Product Manager Pharma at DPL (Dr Paul Lohmann) for BPI TV. DPL manufacture a wide range of organic and inorganic salts, producing 400 products. According to Dr Kattoor, their biopharma customers are most often looking for speed to market – “raising a new product from initial discovery, to manufacturing, to product launch without failing in a clinical trial.”Salts play various roles…

RFID is the New Weapon in the Fight Against Counterfeiting

Counterfeit goods cost the economy up to $250 billion a year, with U.S. Customs and Border Protection agents seizing nearly $80 million in counterfeit pharmaceuticals and personal care products in one year alone. The World Health Organization (WHO) reports that 200,000 people die each year due to ineffective and substandard (counterfeit) malaria drugs. The WHO also reports similar issues in the medical device market. In 2010, over 8% of devices in circulation were counterfeit and that number increased by 50%…

Sumitomo Dainippon Pharma Co., Ltd. Chooses Cytonome’s GigaSort® Cell Sorting Technology for Cell Bioprocessing

Sumitomo Dainippon Pharma Co., Ltd. has installed the GigaSort® Platform in their newly opened Manufacturing Plant for Regenerative Medicine & Cell Therapy in Osaka, Japan. The center is the world’s first commercial iPSC plant. The GigaSort platform is a microfluidic based cell sorting technology that allows the selection of highly specific and pure cell populations in a manufacturing environment. “We are thrilled to be providing the GigaSort technology to Sumitomo Dainippon Pharma Co., Ltd. to enable exciting advances in regenerative…

Culture of 3D Cell Aggregates in Perfusion in a DASbox® Mini Bioreactor System

Three-dimensional (3D) cell aggregates are of great interest for many applications, including disease modeling, drug toxicity assessment, and manufacturing of stem cell-based products. Stirred-tank bioreactors are promising culture systems for 3D cell aggregates, as they allow efficient establishment and maintenance of cell aggregates, process monitoring and control, and process scale-up to larger volumes. Furthermore, they can be operated in perfusion mode, which allows 3D cell aggregates to be sustained longer than in traditional batch cultures. Researchers at the Instituto de…