January 27, 2017
January 27, 2017
This week’s headlines include: Novartis chases rivals with next wave of cancer immunotherapy, FDA Begins Accepting Regenerative Therapy Applications for RAT Designation, Intrexon to Acquire GenVec, Washington state mumps outbreak: 278 cases reported in 5 counties, Roche says FDA grants priority review for Actemra, Asterias’ embryonic stem cell therapy linked to sustained improvements in motor function in small spinal injury trial, and European Commission Offers New Q&A on Biosimilars.
“Novartis (NOVN.S), lagging some other big drugmakers in the first wave of immunotherapy drugs that are revolutionizing cancer treatment, hopes to catch up by focusing on the next wave of immune system-boosting medicines.”
“The US Food and Drug Administration (FDA) on Thursday unveiled a new designation category created as part of the 21st Century Cures Act to allow drugs to be eligible for designation as a regenerative advanced therapy (RAT).”
“Intrexon has agreed to acquire GenVec, the developer of the AdenoVerse™ gene delivery platform, for an undisclosed price, the companies said today. The deal is designed to enable Intrexon to enhance its broad gene transfer capabilities encompassing multiple viral and nonviral platforms by integrating and expanding upon GenVec’s expertise in adenoviral vectors and cGMP drug product manufacturing.”
“Washington state reported Wednesday that there have been 278 confirmed and probable cases of mumps across five counties since October: King, Pierce, Snohomish, Spokane and Yakima. Mumps is a contagious disease caused by a virus spread from person to person through saliva and mucus.”
“U.S. Food and Drug Administration (FDA) has granted priority review designation of Roche’s rheumatoid arthritis medication Actemra for giant cell arteritis (GCA), the Swiss drugmaker said on Tuesday.”
“Asterias Biotherapeutics has posted data from a phase 1/2a trial of its embryonic stem cell-based therapy. After six months, motor levels of all five evaluable patients who received a 10-million-cell dose have improved.”
“The European Commission on Monday unveiled a new question and answer document for those looking to better understand biosimilars. Similar to the Focus explainer on biosimilars, the 9-page EC explainer, available in seven languages, offers a quick 10,000-foot view of the biosimilars landscape, answering questions that patients might have on what a biologic is, what a biosimilar is, how biosimilars compare to generics, what types of studies biosimilars must undergo prior to approval and how to define extrapolation.”
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
The Top 30 Cell Culture Dish Blogs of 2016
I have compiled a list of our most popular 30 Blogs for 2016. Here are the top Cell Culture Dish blogs in alphabetical order.
A New Chemically-defined Medium for use with Suspension-adapted Avian Cells in Vaccine Manufacturing
Direct Inoculum of Bioreactors with CHO Cells from Frozen Seed Bags to Eliminate Continual Seed Trains and improve Facility Utilization
Cool Tool – Pall AcroPrep™ Advance 96-well Long Tip Filter Plate Offers Efficiency and Flexibility in Nucleic Acid Purification
Affordable Biologic Downstream Purification with Single-Use Protein A Membrane
The Top 10 Downstream Column Blogs in 2016
Optimization of a Protein A Chromatography Process for a Herceptin® Biosimilar (Trastuzumab)
Cool Tool – SCOUT® technology reduces time to market and increases chance of success for biopharmaceutical products
Cell Culture Events:
Bioprocess International West – February 27-March 2, 2017, San Francisco
The BPI West 2017 agenda format is designed to break down silos across multiple departments that work in the same stage of development. With four concurrent tracks focused on early stage process development through commercial manufacturing, attendees can collectively share challenges and discuss the solutions needed to improve the speed, cost and quality of biologics development.
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
The Protein A capture chromatography step for monoclonal antibodies (mAbs) is both costly and challenging. Recent advances in continuous multi-column chromatography have drawn great interest due to the potential to dramatically lower the cost and complication of this key purification step in both semi- or fully continuous application. In this webinar, you will learn more about the practical application of continuous multi-column chromatography from the team at CMC Biologics and Pall Life Sciences.
In the present study, the development of a continuous Protein A chromatography process step using KANEKA KanCapA for the capture of a therapeutic mAb is described. 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.
While continuous processing has been applied for several decades, the highly regulated biopharm industry has just started to embrace this approach. The team at Pall Life Sciences has leveraged an industry-leading single-use portfolio to deliver innovative continuous bioprocessing solutions to the market. Join our team as they detail the development journey, and highlight critical advances to date.