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weekly biotechnology news wrap up

May 12, 2017

May 12, 2017

This week’s headlines include: The Senate Just Confirmed Scott Gottlieb to Lead the FDA, GSK’s inhaler improves asthma control in ‘real world’ study, Gates Foundation Supports Achaogen’s Antibacterial Platform with $20.5M, Novartis, Roche back French gene therapy start-up Vivet, Drug Prices Are Growing At The Slowest Rate In Years. Here’s Why It Doesn’t Feel That Way, and JSR Life Sciences Expands Amsphere™ A3 Production Capacity


Headlines:

“The Senate Just Confirmed Scott Gottlieb to Lead the FDA,” Fortune

“The U.S. Senate voted on Tuesday to confirm Dr. Scott Gottlieb, a health policy expert and venture capitalist, as commissioner of the Food and Drug Administration, which regulates everything from food and drugs to tobacco, cosmetics and dietary supplements…”

“GSK’s inhaler improves asthma control in ‘real world’ study,” PharmaTimes

“GlaxoSmithKline and Innoviva have unveiled data from a second ground-breaking Salford Lung Study (SLS) showing that Relvar Ellipta significantly improved asthma control versus patients’ standard therapy. Patients initiated with Relvar Ellipta (fluticasone furoate/FF and vilanterol/VI) had twice the odds of achieving an improvement in asthma control than those continuing with their usual care, which included inhaled corticosteroids (ICS) administered as monotherapy or as ICS/LABA (long acting beta agonist) combinations…”

“Gates Foundation Supports Achaogen’s Antibacterial Platform with $20.5M,” Genetic Engineering News

“The Bill and Melinda Gates Foundation has awarded Achaogen $10.5 million in grant funding and is making a $10 million investment in the South San Francisco-based firm to support the identification of monoclonal antibodies (mAbs) against serious, multidrug-resistant (MDR) Gram-negative bacteria. The initial grant will fund Achaogen’s program to discover mAbs against Acinetobacter baumannii, which is the major cause of neonatal sepsis. If this project is successful, Achaogen may receive future grants from the Gates Foundation for additional antibody discovery and development programs…”

“Novartis, Roche back French gene therapy start-up Vivet,” Reuters

“Its lead program VTX801, which is expected to enter clinical testing by the end of 2018, targets a condition called Wilson disease caused by a defective gene in liver cells that can require liver transplantation and is sometimes fatal…”

“Drug Prices Are Growing At The Slowest Rate In Years. Here’s Why It Doesn’t Feel That Way,” Forbes

“You’d think, from the political clamor, that the cost of prescription drugs is rising out of control. But actually, growth in drug prices this year was half of last year, according to a new report from The QuintilesIMS Institute, an arm of a gigantic pharmaceutical industry consulting firm. More than that, the average out-of-pocket cost to consumers has decreased…”

“JSR Life Sciences Expands AmsphereA3 Production Capacity,” Business Wire

“JSR Life Sciences (JLS), the global life sciences focused division of JSR Corporation, today announced plans for expansion of its production capabilities of AmsphereTM A3 protein-A chromatography resin at JSR’s Belgium subsidiary, JSR Micro NV. This expansion will effectively increase the company’s production capacity by 6 times and provide all-important redundancy in its manufacturing capability…”

Recent Articles on Cell Culture Dish and Downstream Column:

Cell Culture Dish

 


Downstream Column logo tall

Webinars:

Developing Practical Single-Use Processes for New Vaccine Formulations

May 16, 2017- 10:00 AM EST

SUMMARY

New vaccine process designs – and all the kinks that go with them – are typically hammered out in a small scale capacity, for example, prior to manufacturing for early phase human clinical trials. They are then upsized and further defined for industrial scale to supply the vast market. Single-use technologies (SUTs) have been a hot topic for several years now and their advantages well-known: easy product changeover, processing in lower classification areas, reduced CAPEX, elimination of glass, sterility assurance, to name a few. In vaccine manufacturing, SUTs are used throughout the processing stages, from cell culture all the way to filling. SUTs are quickly and conveniently designed, purchased and implemented for short-term manufacturing of clinical trial phase materials. Here a large percentage of new vaccines in Research and Development do not even make it to market.

As the final production stages are critical as they are the last stages before patient injection, the scope of thisarticle covers SU applications involving drug substance formulations, adjuvant processing, final bulk formulation and filling. The actual process itself may include some or all of the following: filtration, pumping, ingredient addition, mixing, adsorption, filling, labelling, sampling and and storage.

In this presentation only liquid formulations (“presentations”) will be discussed.

Presented by Kirsten Strahlendorf of Sanofi Pasteur

Webinar – Scale-up of Continuous Chromatography using Cadence™ BioSMB Process System

May 18, 2017 – 9:00 AM EST

Continuous bioprocessing for biologics manufacturing is being adopted in the biopharmaceutical industry by big players such as Merck. Pall Life Sciences has partnered with Merck to help bring this innovative technology platform to fruition.
In this webinar, Pall’s development journey in continuous bioprocessing will be described along with highlights of recent technology advances

Merck will present the development of a continuous Protein A chromatography process step using KANEKA KanCapA™ for the capture of a therapeutic mAb.  The method was developed initially in a batch mode and then transferred to the Cadence BioSMB PD system. This five column process was then successfully scaled-up 150-fold using the Cadence BioSMB Process system. The entire process development and scale-up was completed within four weeks and described in detail along with the process economic benefits of using multi-column chromatography.

Participants will learn:

  • How to reduce facility footprint, capital expenses, and product cost of goods
  • How to improve your process productivity, flexibility, and further facilitate the utilization of single-use and/or disposable technologies

Speakers
Dr Peter Levison, Senior Marketing Director- Downstream Processing, Pall Life Sciences
Dr Mark Brower, Principal Scientist, Merck

Cell Culture Events:

Cell Culture World Congress USA 2017 – May 24, 2017, Hilton San Diego Resort and Spa, San Diego, CA

The vision of Cell Culture World USA is to provide new, relevant content on process development for cell culture specific scientists working in bio manufacturing companies developing antibodies and immunotherapies. Over 4 years, the Congress has become a technical and networking forum for bioprocessing professionals to provide cutting-edge commentary, present novel and never-before-seen case studies, and highlight technological advancements to the industry.

Our 2017 event will feature a more focused structure, zeroing in on the topics that interest cell-culture specific scientists the most. Immunotherapies are the talk of the industry, and they’ll be a huge topic for this year’s event as well.

Download Brochure: https://goo.gl/t5ZRvx

Register now: https://goo.gl/KTOdxq

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.