Monday, October 15, 2018 Daily Archives

Ask the Expert: Key Considerations for Advanced Therapies Manufacturing

On 12 September 2018, Thomas Page, PhD (vice president of engineering and asset development at Fujifilm Diosynth Biotechnologies, FDB) shared a brief overview of challenges encountered in manufacturing of advanced biotherapeutics. Page’s Presentation FDB is a contract and development manufacturing organization (CDMO) that uses microbial and mammalian cell lines to produce protein therapeutics as well as viral vaccines and gene therapies. The company’s Center of Excellence for Advance Therapies Manufacturing is located in Texas. FDB set out some years ago…

Ask the Expert: Bioproduction Efficiencies Gained Using ExpiCHO Stable Production Medium

The transition from transient to stable production workflow with Chinese hamster ovary (CHO) cells requires a change in culture medium. On 22 August 2018, Shreya Lowmaster (field applications scientist at Thermo Fisher Scientific) discussed transient to stable solutions for moving from research to commercial production. Lowmaster’s Presentation  Researchers are demanding higher titers in transient systems, and many people use CHO systems as an alternative to HEK293 cells. The Thermo Fisher Gibco ExpiCHO Expression System kit was developed for transient expressing…

Computational Science Changes Biolaboratory Design

Until relatively recently, life-science research was characterized by test tubes, Petri dishes, and centrifuges. Now, as with many industries, the life sciences are undergoing a digital transformation. Computational science is changing laboratory design. The healthcare industries always have generated large amounts of data. What has changed is the available information technology. With the growth of cloud computing, large data sets — and the high-speed tools for analyzing them — are available increasingly to a degree not possible with traditional servers…

Merck drops Lantus biosimilar, blames pricing and production cost concerns

Merck & Co. has ended the commercialization of Lusduna, a version of Sanofi’s Lantus (insulin glargine), and will pay Samsung Bioepis a termination fee of around $155 million. In 2014, Merck & Co. (known as MSD outside of North America) entered into an agreement with Korean biosimilar maker Samsung Bioepis to commercialize an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes. The product, Lusduna, formerly MK-1293, was approved in Europe in January 2017…

BMS invests in Compugen, grants access to Opdivo for combo trial

Compugen has gained access to top-selling programmed death-1 (PD-1) inhibitor Opdivo (nivolumab) through collaboration and a $12 million investment from Bristol-Myers Squibb. Israeli early-phase biotech Compugen’s candidate COM701, a first-in-class therapeutic antibody targeting PVRIG, will be investigated in combination with Bristol-Myers Squibb’s monoclonal antibody (MAb) Opdivo (nivolumab) after signing a clinical partnership with the big pharma firm. “We discovered PVRIG as immune checkpoint proteins using our computational target discovery platform. We prioritized this target among the marketable other internal programs…