weekly biotechnology news wrap up

April 14, 2017

April 21, 2017

This week’s headlines include: FDA continues to approve most drugs faster than its European counterpart, Scotland first UK nation to routinely offer HIV PrEP, GE Healthcare Adds to Its Cell Therapy Portfolio by Acquiring Asymptote, Mesoblast takes off as cell therapy for heart failure passes interim test, Roche’s Alecensa notches trial win against Pfizer’s Xalkori, and FDA Delays eCTD Requirements for Master Fi


“FDA continues to approve most drugs faster than its European counterpart,” STAT News

“Amid ongoing skepticism of the US Food and Drug Administration, a new analysis finds the agency is notably faster at reviewing and approving new medicines than its counterpart in Europe. And the researchers suggest the results, which resemble an earlier comparison, should reassure FDA critics as Congress looks to renew a law that allows the agency to collect industry funds for product reviews…”

“Scotland first UK nation to routinely offer HIV PrEP,” PharmaTimes

“Scotland will become the first UK nation to routinely offer HIV pre-exposure prophylaxis to all eligible patients after the Scottish Medicines Consortium backed the use of Gilead’s Truvada alongside four other new therapies to be funded by the NHS…”

“GE Healthcare Adds to Its Cell Therapy Portfolio by Acquiring Asymptote,” Genetic Engineering News

“GE Healthcare said today it has acquired Asymptote for an undisclosed price in a deal that the buyer said would strengthen its cell therapy portfolio with technologies designed to enable the cryopreservation of cellular materials…”

“Mesoblast takes off as cell therapy for heart failure passes interim test,” Fierce Biotech

“At the halfway point, a phase 3 trial of Mesoblast’s off-the-shelf cell therapy for chronic heart failure is on track and should continue to completion, say advisers. Shares in the Australian biotech hit a 12-month high on the update from the trial, which came after it enrolled 270 out of a planned total of 600 patients with moderate CHF and—crucially—revealed no safety issues with Mesoblast’s MPC-150-IM candidate…”

“Roche’s Alecensa notches trial win against Pfizer’s Xalkori,” Reuters

“Roche’s Alecensa kept people with a specific lung cancer alive longer without their disease progressing than Pfizer’s Xalkori, the Swiss drugmaker said on Monday, as it seeks to move in on the U.S. company’s share of early treatment of the disease…”

“FDA Delays eCTD Requirements for Master Files,” Regulatory Focus

“The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format. In a revised guidance released Friday, FDA says it is delaying the requirement for drug master files (DMF) and biological product files (BPF) to be submitted in eCTD format until 5 May 2018…”

 Recent Articles on Cell Culture Dish and Downstream Column:

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Design, Characterization, and Scale-Up Strategy for a New Single-Use Production-Scale Bioreactor – April 27th 11:00 EST

The design of the initial range of single-use stirred bioreactors was cylindrical, essentially copying that of traditional stainless steel bioreactors. The cylindrical shape with dished ends was intended to minimize the expensive steel stainless wall thickness and still be strong enough to withstand the internal pressure developed during steam sterilization. However, since single-use biocontainers can be supplied presterilized, novel shapes can now be considered. Indeed a square cross-section design demonstrates some significant advantages over a cylindrical one.

This GEN webinar will first introduce and discuss the engineering concepts of the Allegro™ STR bioreactors, a square bioreactor design with volumes of 200 L, 1000 L, and 2000 L, and then utilize these concepts to demonstrate scale-up from the bench with a live culture.

Who Should Attend

  • Upstream bioprocessing engineers
  • Upstream process development scientists
  • Clinical and commercial manufacturing supervisors and technicians
  • QA/QC scientists

You Will Learn

  • Why a square cross-section brings significant advantages to the upstream process, for handling, process assurance, while maintaining optimal cell culture performance
  • About the performance of a square-shaped bioreactor, in terms of mixing efficiency, mass transfer of oxygen (kLa), and CO2 stripping
  • Applying system engineering principles toward bioreactor characterization, and how tech transfer methods are leveraged across designs, from the bench to production vessels

Cell Culture Events:

World Vaccine Congress – April 10-12, 2017, Washington D.C.

The 17th Annual World Vaccine Congress is the place where the global vaccine industry meets to discuss commercial and scientific issues around regulation, strategy, manufacturing, trials, partnering, influenza, cancer, emerging diseases and veterinary vaccines.

Across 150 sessions, you will learn from leading experts across the issues most impacting on the wider vaccine sector, as well as delve into your specialist area of research and job focus in co-located conferences.

Meet over 700 of your peers in one room and take advantage of the multiple extended networking breaks, co-located World Vaccine Congress (including 7 streams on Immune Profiling, Cancer & Immunotherapy, Influenza & Respiratory, Clinical Trials, Emerging Diseases, Partnerships, Veterinary Vaccines and Bioprocessing & Manufacturing) as well as the evening drinks reception.

For more information, please visit the website https://goo.gl/nJ2bZ1

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.