May 5, 2017

May 5, 2017

This week’s headlines include: Here’s the visual proof of why vaccines do more good than harm, Dr. Julius Youngner, Polio Vaccine Pioneer, Dies at 96, B is for biotech: Alphabet, and its search for life science glory, Charter Medical Announces Exclusive Global Distribution Agreement with INCELL Corporation, MockV Solutions Announces Collaboration with Texcell N.A. to Assess MVP Technology, and U.S. FDA approves Novartis’ leukemia treatm


“Here’s the visual proof of why vaccines do more good than harm,” Science

“Vaccines have beat back infectious diseases. Bubbles represent reported U.S. cases, but not all diseases were notifiable in all years. For example, mumps was not reported until 1968, the year after a vaccine was licensed…”

“Dr. Julius Youngner, Polio Vaccine Pioneer, Dies at 96,” The New York Times

“Dr. Julius Youngner, an inventive virologist whose nearly fatal childhood illness destined him to become a medical researcher and a core member of the team that developed the Salk polio vaccine in 1955, died on April 27 at his home in Pittsburgh. He was 96…”

“B is for biotech: Alphabet, and its search for life science glory,” Fierce Biotech

“While you’re searching for, statistically speaking, cat videos, Alphabet’s venture arm GV is searching for life sciences companies that are working on new ways to help people live longer. The California-based GV, formerly Google Ventures, which was launched in 2009 and has around $2.4 billion under management, started off with a Silicon Valley approach, but is now increasingly looking to add bio to tech…”

“Charter Medical Announces Exclusive Global Distribution Agreement with INCELL Corporation,” Digital Journal

“Charter Medical Ltd., a Fenner PLC subsidiary (LSE:FENR), a globally recognized manufacturer of products for the regenerative medicine and bioprocessing industries, announced today that it has established a strategic partnership with INCELL Corporation, an innovative developer and manufacturer of specialty medias and formulated solutions for tissue and cell collection, transport, processing and storage. The partnership will enable both organizations to meet the growing customer demand for more comprehensive solutions in cell culture, cell expansion, and cryopreservation…”

“MockV Solutions Announces Collaboration with Texcell N.A. to Assess MVP Technology,” Texcell

“MockV Solutions, Inc. (MockV or the Company), a biotechnology company developing non-infectious viral clearance prediction products that address the unmet needs of process development scientists as they establish biopharmaceutical manufacturing platforms, announced today that it is partnering with Texcell North America, Inc. (Texcell N.A.) to assess its Mock Virus Particle (MVP) technology…”

“U.S. FDA approves Novartis’ leukemia treatment,” Reuters

“The U.S. Food and Drug Administration approved Novartis AG’s Rydapt as an initial treatment for acute myeloid leukemia (AML) as well as certain other blood disorders, the agency said on Friday. AML is a cancer that originates in the bone marrow and progresses rapidly, resulting in an abnormal increase in white blood cells…”

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Monday, May 8, 2017

GMP Proteins for Cell Therapy Manufacturing

GMP (Good Manufacturing Practice) growth factors and cytokines designed for therapeutic manufacturing are a critical component in defined medias. To date, the cell therapy industry has accepted the term GMP for this reagent class despite the fact that there is no direct oversight by regulatory authorities. These proteins are intended to be used during further manufacturing and do not come in direct contact with the patient. In fact, cell therapy manufacturers need to take steps to ensure that reagents used for further manufacturing are removed before the cells can be used in the clinic. In addition, FDA-regulated, clinical grade proteins that can be directly used as therapeutics may also be described as GMP, leading to confusion of the term “GMP” within different contexts.

We recently published a blog, “GMP Proteins for Cell Therapy Manufacturing: Top 6 Things to Know,” that discusses what you should look for in a supplier. It was a popular piece with readers, so we asked the author, Tim Manning, if he would host an Ask the Expert session on the topic. Tim was kind enough to agree to answer questions from readers this week on the topic of GMP protein manufacturing..

This should be of interest to anyone interested in cell therapy research or those manufacturing cells that will be used as therapeutics.

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.

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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.