Author Archives: BPI Staff

December Spotlight

Revealed: Where Scientists Want to Work When you’re in the business of life-science innovation, highly trained employees are worth every penny. That’s why biotechnology companies pay top dollar for amenities-rich locations and facilities in the top US life-science real estate markets, according to Jones Lang LaSalle’s (JLL’s) Life Sciences Outlook published this past summer. JLL is a professional services firm that specializes in real estate and investment management. Its report says that life-science professionals have high expectations for their workplaces.…

November Spotlight

Crowdsourcing Cancer Research and Biomanufacturing In June, BioMed X launched two new global calls for application together with Merck KGaA for RNA splicing in cancer and for engineering of high-performance production cell lines. Talented young scientists from top universities and research institutions were invited to submit innovative project proposals and apply for a research fellowship at the BioMed X Innovation Center in Heidelberg, Germany. BioMed X was founded in 2013 in collaboration with Merck, its first pharmaceutical partner. Since then,…

October Spotlight

Introducing New Editorial Advisor Dr. Sanjay Nilapwar works as a purification process scientist in the novel-molecules group of Medimmune in Gaithersburg, MD, where he is also part of the platform chemistry, manufacturing, and controls (CMC) development team for antibody–drug conjugate products. In this position, he looks after the transitioning of ADC and monoclonal antibody (MAb) molecules as candidate drugs from development to the manufacturing stage, which encompasses cycles 1 and 2 purification process development, technology transfer and related CMC aspects…

Ask the Expert for Better Single-Use Powder Containment for Media and Buffers

Dave Howes (senior applications specialist at ILC Dover) introduces his company’s market-leading solution for single-use powder containment. Howes’s Presentation Some challenges in biopharmaceutical powder manufacturing include optimizing open-suite facilities; minimizing product loss from spills; lessening waste and cross-contamination; reducing worker exposure to airborne particulates; and lowering the risk of ignition with flammable materials. Characteristics to look for in a powder-transfer system are a system design that is exclusively meant for powders (not adapted from liquid-transfer designs) large-diameter top openings for…

Ask the Expert: Human-Error Reductions — Proper Task Performance in GMP Biomanufacturing

Tony Fultz (director of upstream manufacturing at Fujifilm Diosynth Biotechnologies) presented an “Ask the Expert” webinar on 23 August 2017. Fultz’s Presentation Human error was responsible for about 75% of batch failures at contract manufacturing organization Fujifilm Diosynth Biotechnologies in 2016. Technicians operate in a dynamic and stressful environment, both contributing factors to human error. With multiple projects running concurrently, some employees are involved in executing several processes during a shift. The company has several ways of reducing human error:…

Ask the Expert: CHT Column Packing Is Easier Than You Think

On 6 September 2017, Mark Snyder (manager of the process chromatography R&D applications group at Bio-Rad Laboratories) gave an “Ask the Expert” presentation on process-scale column packing with CHT ceramic hydroxyapatite media. Snyder’s Presentation CHT is an incompressible mixed-mode chromatography medium using cation exchange and calcium-affinity interactions, and it is available in 40-μm and 80-μm particle sizes. This medium can be used to purify monoclonal, polyclonal, and bispecific antibodies; antibody fragments; other recombinant proteins and isozymes; viruses, viral particles, and…

September Spotlight

“Smaller Is Better” Chemical Bioproduction Ramon Gonzalez, professor of chemical and biomolecular engineering at Rice University and director of its Advanced Biomanufacturing Initiative (iBIO), believes that “waste” methane represents an opportunity for biomanufacturing that should not be missed. Instead of getting burned off, methane could and should generate profits. With advancements in biomanufacturing, wild-type or genetically modified bacteria can turn carbon-rich methane into valuable chemicals — producing them at smaller scales in more environmentally friendly processes than those of classical…

New Tools to Improve Cell Viability, Purity, and Recovery

Presented by Sean Kevlahan (chief executive officer, Quad Technologies) 11:00–11:20 am Kevlahan described Quad Technologies as an early stage company founded in 2013 and headquartered in Woburn, MA. Its approach to cell and gene therapies is offering bioprocessing tools with a biomaterials focus. The company’s QuikGel platform is a hydrogel-based technology for making different sizes of hydrogel microbeads that will dissolve under gentle conditions. The beads can be magnetic or nonmagnetic for both research and bioprocessing applications. This technology provides Quad…

Advanced Therapies Capabilities at FDBT

Presented by Yan Zhi (program design technical lead, Fujifilm Diosynth Biotechnologies) 11:20–11:40 am Fujifilm Diosynth Biotechnologies Texas (FDBT) has two dedicated viral products facilities: The National Center for Therapeutic Manufacturing (NCTM) building was designed for process development and early phase clinical good manufacturing practice (GMP) production of advanced therapeutics including viral, microbial, and plasmid products. The newly built Flexible Biomanufacturing Facility (FBF) is designed for clinical and commercial GMP production of viral products. View the full video here – Login Required…

Covering a Spectrum of New Product Development Technologies: From Cells to Cell Therapy

Presented by Stewart McNaull (senior vice president of business development, KBI Biopharma) 11:40 am–12:00 pm Founded in 2004, KBI Biopharma operates a core facility in Durham, NC. In 2013, the company needed more space and set up laboratories in Research Triangle Park, NC. Using mammalian cell lines, it has developed both monoclonal antibody (MAb) and non-MAb platforms. It acquired a former Merck site in Boulder, CO, in 2014 and retained staff experts in fermentation expression, refolding, and mass spectrometry. With manufacturing…