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.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
I have compiled a list of our most popular 30 Blogs for 2016. Here are the top Cell Culture Dish blogs in alphabetical order.
Much of current cell-based vaccine manufacturing is done in cell lines like Vero (African green monkey kidney), MDCK (Madin-Darby canine kidney) or CEF (chicken embryo fibroblast) cells. These cell lines are adherent cells that require a surface to attach to in order to proliferate and produce viruses. Production scale-up with adherent cells is generally more challenging than with suspension cell cultures due to the surface area requirements for adherent cells…
Flexibility in cell culture manufacturing via a reduction in process duration can be a key strategy for maximizing facility utilization and facilitating the production of multiple therapeutics from a facility. A key bottleneck is the seed train, which can add weeks to the timeline of the production culture. Seeding production bioreactors with a direct, cryopreserved CHO cell inoculum could possibly eliminate the need for a lengthy, continuous seed train and provide other numerous benefits…
As the Cell Therapy industry increasingly moves from research to clinical trials and commercial manufacturing, it is necessary to scale up manufacturing processes to meet increasing product demand. Clinical and commercial manufacturing also requires that the manufacturing process be compatible with quality and regulatory expectations to ensure safety…
At this year’s Boston Biotech Week there were many exciting talks on downstream purification and associated new technologies. In particular, there were several talks about optimizing the downstream purification process. One very interesting talk, given by Renaud Jacquemart, PhD Principal Scientist, Director Vaccines Process Sciences, was titled “Enabling Manufacturing Of Affordable Biologics Through The Use Of A Protein A Membrane In A Single-Use Purification Strategy ” and focused on the application of a fully single-use chromatography purification process in place of resins. This strategy envisions the use of a unique Protein A membrane for which Natrix recently signed collaboration agreements with Merck & Co. and Sanofi…
I have compiled a list of our most popular 10 Blogs for 2016. Here are the top Downstream Column blogs in alphabetical order…
As part of our Boston Biotech Week 2016 coverage, we will be writing about some of the posters presented at the conference. One poster that caught my eye for downstream was presented by Oncobiologics and JSR Life Sciences, “Optimization of a Protein A Chromatography Process for a Herceptin® Biosimilar (Trastuzumab).” In the poster, Oncobiologics and JSR Life Sciences describe the steps taken in identifying the most efficient chromatography process…
Only 1 out of each 50 biopharmaceutical new product candidates makes it through the research phase into clinical trial testing and subsequently to the market. This high attrition rate is predominantly in the early development phases and is attributed to (I) undesired pharmacokinetics profile (39%), (II) lack of efficacy (30%), (III) in vivo toxicity in preclinical model (11%), (IV) adverse effect in humans (10%), and (V) other reasons, of which most commonly commercial arguments based on cost of goods (10%). It is therefore imperative that technologies become available that allow significant de-risking of biopharmaceutical product trajectories in the early research and development phase. The importance of this has been recognized by the field with the introduction of the “Design of Experiments” (DoE) approach, identifying critical quality attributes and performance attributes like yield, glycosylation, potency, and consumable costs of a manufacturing process. Owing to the DoE approach, scientists now have a tool to strategize the development of a novel product candidate. That said, it is often found that due to the complexity of many novel molecules, the number of parameters that need to be tested still requires vast numbers of experiments which are time consuming and costly…
Cell Culture Events:
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
Case Study: CMC Biologics Explores the Potential of Continuous Multi-Column Chromatography – February 6, 2017
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.
Case Study: Merck Presents Scale Up of Continuous Chromatography using Cadence BioSMB Process System – February 20, 2017
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.
Continuous Bioprocessing Solutions: An Update on Significant Enabling Technology Advances – March 7, 2017
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.
“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.”
“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’ embryonic stem Cell Therapy linked to sustained improvements in motor function in small spinal injury trial,” Fierce Biotech
“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.”