weekly biotechnology news wrap up

July 14, 2017

July 14, 2017

This week’s headlines include: F.D.A. Panel Recommends Approval for Gene-Altering Leukemia Treatment, Sanofi to Buy Insect Cell Vaccines Company Protein Sciences for Up to $750M, Measles ‘tragedy’ kills 35 across Europe, Computer-Simulated Tests Eyed at FDA to Cut Drug Approval Costs, FDA Approves First New Sickle Cell Drug in Almost 20 Years, and UK launch for Pfizer’s MenB jab Trumenba.


“F.D.A. Panel Recommends Approval for Gene-Altering Leukemia Treatment,” The New York Times

“A Food and Drug Administration panel opened a new era in medicine on Wednesday, unanimously recommending that the agency approve the first-ever treatment that genetically alters a patient’s own cells to fight cancer, transforming them into what scientists call “a living drug” that powerfully bolsters the immune system to shut down the disease…”

“Sanofi to Buy Insect Cell Vaccines Company Protein Sciences for Up to $750M,” Genetic Engineering News

“Sanofi is looking to bolster its recombinant-based influenza vaccine portfolio through the acquisition of Protein Sciences for $650 million upfront and potentially up to another $100 million in milestones. The transaction, which has been approved by the Protein Sciences board and the majority of its shareholders, is expected to close during Q3 2017, subject to regulatory clearance…”

“Measles ‘tragedy’ kills 35 across Europe,” BBC

“Thirty-five people have died in the past year from measles outbreaks across Europe, the World Health Organization has warned. It described the deaths – which can be prevented with vaccination – as an “unacceptable tragedy”…”

“Computer-Simulated Tests Eyed at FDA to Cut Drug Approval Costs,” Bloomberg

“Computer simulations may get a role alongside human testing as part of an effort to bring new medications and medical devices to market more quickly and cheaply. The U.S. Food and Drug Administration outlined a proposal Friday to help integrate computer modeling and virtual testing as part of the regulatory approval process for manufacturers — a step the agency said could save money while helping find cures for puzzling conditions such as Alzheimer’s disease…”

“FDA Approves First New Sickle Cell Drug in Almost 20 Years,” Regulatory Focus

“The US Food and Drug Administration (FDA) on Friday granted approval to Emmaus Medical’s Endari (L-glutamine oral powder), the first treatment approved for patients with sickle cell disease in almost 20 years…”

“UK launch for Pfizer’s MenB jab Trumenba,” PharmaTimes

“Pfizer’s new meningitis B vaccine Trumenba is now available in the UK for teens and young adults providing an additional option for vaccination against the disease…”


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

Modernizing Biopharmaceutical Manufacturing: from Batch to Continuous Production

19th July 2017 | 10AM EST / 3PM GMT


The importance and value of continuous bioprocessing, both upstream and downstream has economic and sustainability advantages and due to the modular nature of continuous bioprocesses means that industry is able to adapt more rapidly to changing market demands. Continuous biopharmaceutical manufacturing in the context of other industries that have already successfully adopted continuous processing. Factor other than scientific ones, are the barriers to change from batch to continuous production. an excellent example of the manufacturing strategies of the steel industry in the 20th century, when this industrial sector incrementally switched from batch to continuous operations. biopharmaceutical industry has reached a stage that requires a change in the production paradigm. For a certain class of biopharmaceutical products upstream continuous manufacturing has always been applied: for example, unstable proteins that rapidly degrade in the culture broth. In order to obtain a high quality product, the residence time in the reactor must be minimized. This can only be achieved with continuous cultivation and preferably with perfusion reactors. a brief overview on the types of cell retention devices currently used in biopharmaceutical industry.

Furthermore, this is a universal production platform that can be extended to other classes of products, such as antibodies, which are relatively stable molecules. continuous manufacturing is as productive and with a much smaller footprint of the manufacturing plant, avoiding multiple non-value added unit operations. In essence, the investment for a continuous plant is much smaller compared to a batch-operated one.

Presented by Robert Dream, PE, CPIP of HDR COMPANY LLC

Register Here