weekly biotechnology news wrap up

June 23, 2017

June 23, 2017

This week’s headlines include: Sanofi to invest further in biologics, Priority Generic Drug Reviews: New FDA Draft Guidance, Clovis’s ovarian cancer drug set for label expansion, shares soar, Cell Medica Acquires Catapult Therapy for Lead WT1-TCR T-Cell Therapy, Danger map reveals health threat zone, and FDA Approves Quicker-To-Administer Drug for Blood


Headlines:

“Sanofi to invest further in biologics,” Reuters

“Sanofi announced plans to invest 600 million euros ($673 million) annually over the next two to three years in the field of biologics production, an area of strong growth potential…”

“Priority Generic Drug Reviews: New FDA Draft Guidance,” Regulatory Focus

“In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II), the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs…”

“Clovis’s ovarian cancer drug set for label expansion, shares soar,” Reuters

“Clovis Oncology Inc said on Monday late-stage data on its already-approved ovarian cancer drug showed that the treatment could benefit four times as many patients, sending shares of the U.S. biotech soaring 50 percent…”

“Cell Medica Acquires Catapult Therapy for Lead WT1-TCR T-Cell Therapy,” Genetic Engineering News

“Cell Medica is buying Catapult Therapy TCR and the firm’s gene-modified WT1-TCR (Wilms’ tumor 1 protein–T-cell receptor) T-cell therapy candidate. The treatment is currently in Phase I/II development for the potential treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)…”

“Danger map reveals health threat zone,” BBC News

“The EcoHealth Alliance in New York looked at mammals, the viruses they harbour and how they come into contact with people. It revealed bats carry more potential threats than other mammals. The researchers hope the knowledge could be used to prevent the next HIV, Ebola or flu…”

“FDA Approves Quicker-To-Administer Drug for Blood Cancers,” US News and World Report

“U.S. regulators have approved a more convenient version of a blockbuster drug for treating three common blood cancers. The Roche Group’s Rituxan, on the market for 20 years, is administered in a hospital or clinic through an intravenous drip that can take several hours. On Thursday, the Food and Drug Administration approved the Swiss drugmaker’s new version, Rituxan Hycela (RIH’-tux-en HEYE’-cell-uh). It’s injected in about six minutes, shortening clinic visits…”

Recent Articles on Cell Culture Dish and Downstream Column:

Cell Culture Dish


Downstream Column logo tall


Webinars:

Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption

Presented by: James Hathcock, Ph.D. & Hélène Pora, Ph.D.

Date: Thursday, June 29, 2017
Time: 11:00 AM PDT / 1:00 PM CDT / 2:00 PM EDT

Date: Tuesday, July 04, 2017
Time: 9:00 AM BST / 10:00 AM CEST / 1:30 PM IST / 4:00 PM SGT / 5:00 PM JST

Duration: 1 hour

A primary concern limiting the rapid adoption and implementation of single-use technology has centered on standardizing single-use component extractables data packages to be used for end user risk assessments. Experimental findings and insights from execution of both the BPOG and USP <665> extractables protocols on multiple single-use components will be shared, including similarities and differences in extraction profiles. Case studies will also be presented illustrating how Pall’s growing portfolio of BPOG extractables datasets can be used to help support component qualification and overall toxicological risk assessment for single-use systems.

Registration

SUMMARY

Continuous multi-column chromatography (MCC) has been gaining increasing interest as an enabling bioprocessing technique that allows for increases in specific productivity (g/L/hr) and operating binding capacity (g mAb/L sorbent) over traditional batch solutions. With recent advances, users have reported an increase in cost savings stemming from reduced resin volumes, lower buffer consumption, and increased resin usage.

Mark Pagkaliwangan presents on July 18th at 1PM EDT, with David Johnson moderating, as they discuss MCC solution advances with processes utilizing two columns or more. They will explore how the total number of columns used in a process can affect performance, and how titer and flowrate can be optimized with more columns for greater efficiency and productivity.

Registration for the America
Registration for Europe/Asia

Cell Culture Events:

Cell Culture & Cell Therapy: Bioprocessing Conference – June 26-27, 2017, Philadelphia

MarketsandMarkets put together a unique platform to establish the reproducible and robust manufacturing processes for the production of stable cell culture and therapeutic cells. At the Cell Culture & Cell Therapy: Bioprocessing Conference scheduled to be held in Philadelphia, USA on 26 – 27 June 2017, leading experts in the industry will be gathered to discuss strategies, technologies and innovations in the area of bioprocessing of cell culture and cell-gene therapies.