weekly biotechnology news wrap up

June 30, 2017

June 30, 2017

This week’s headlines include: Repligen Merging with Spectrum Labs in $359M Deal, Needle-Free Flu Vaccine Patch Works as Well as a Shot, FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests, NYU scientists zero in on mechanism for removing plaque from arteries, BE Licenses Takeda’s Measles and Pertussis Vaccines for India and China, and Roche says new haemophilia drug cuts bleed rate by 87 pct.


Headlines:

“Repligen Merging with Spectrum Labs in $359M Deal,” Genetic Engineering News

“Repligen said today it plans to merge with privately-held Spectrum Laboratories, in an approximately $359 million deal that Repligen said will accelerate the growth of its filtration business and enhance its position as a leading developer of single-use and continuous-manufacturing technologies for bioprocessing…”

“Needle-Free Flu Vaccine Patch Works as Well as a Shot,” NBC News

“A press-on patch that delivers flu vaccine painlessly worked as well as an old-fashioned flu shot with no serious side effects, researchers reported Tuesday…”

“FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests,” Regulatory Focus

“At a Senate hearing on President Donald Trump’s FY2018 budget request for the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb vowed to eliminate the backlog of orphan drug designation requests and said he will soon release “modern and risk-based” tools for assessing new treatments, especially for rare diseases and conditions with no effective treatments…”

“NYU scientists zero in on mechanism for removing plaque from arteries,” Fierce Biotech

“Low-density lipoprotein (LDL) is commonly called “bad cholesterol” because it builds up along the walls of the arteries, forming plaques that can cause deadly blockages. But what if a key player in that inflammatory, plaque-building process also had the ability to switch roles, opening up and healing the arteries instead of blocking them?”

“BE Licenses Takeda’s Measles and Pertussis Vaccines for India and China,” Genetic Engineering News

“Biological E. (BE) negotiated two licensing agreements with Takeda for the latter’s measles and pertussis vaccines, which will allow BE to develop and commercialize affordable combination vaccines in India, China, and low- and middle-income countries. Takeda has sold both the vaccines in Japan for more than 20 years…”

“Roche says new haemophilia drug cuts bleed rate by 87 pct,” Reuters

“Roche’s investigational haemophilia drug emicizumab cut the bleed rate by 87 percent in patients who had developed resistance to standard treatment, compared with those who instead got bypassing agents, the Swiss company said on Monday…”

Recent Articles on Cell Culture Dish and Downstream Column:

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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 Americas

Registration for Europe/Asia