This week’s headlines include, stem cell applications, global biosimilars pipeline grown by 40%, big Pharma looking at past product portfolios, business deals, and organs on chips.
Cell Culture Dish – Ask the Expert:
The vast advances in technologies for the efficient generation of footprint-free induced pluripotent stem cells (iPSC) have led to the creation of several iPSC lines from varying sources, genetic backgrounds, and derivations in different medias and growth conditions, thus necessitating thorough characterization of the resulting cell lines.
One critical step in establishing iPSC lines involves the early identification of true iPSC clones and their subsequent characterization to ensure functional pluripotency. Various methods of characterization, ranging from visual morphological observation to the use of differentially expressed biomarkers are utilized for the initial identification of pluripotent cells. Dyes such as Alkaline Phosphatase Live Stain enable the early detection of emerging iPSC colonies that can be used in combination with morphological assessment to pick the right iPSC clone for further expansion. Established clones are further subjected to a combination of in vitro and in vivo cellular analysis to confirm functional pluripotency based on expression of self-renewal markers and trilineage differentiation potential. While such traditional methods have been successfully used, there is a need for a uniform standardized method for comprehensive characterization. Recently, the TaqMan® hPSC Scorecard™ Panel, a real-time PCR gene expression assay, provides a rapid molecular method to generate quantitative transcriptome data for the confirmation of functional pluripotency.
Join Uma Lakshmipathy, Principal Scientist at Thermo Fisher Scientific, to explore various options for identification and characterization of pluripotent stem cells.
Don’t miss this chance to have your identification and characterization pluripotent stem cell questions answered!
Cell Culture Events
Annual Meeting of the International Society for Stem Cell Research – June 18-21, 2014, -Vancouver, Canada
Cell Culture Dish will be blogging from this event with daily updates. If you are attending, don’t miss:
An Integrated Workflow for the Isolation, Expansion, and Characterization of Hematopoietic Progenitors and their Conversion to Induced Pluripotent Stem Cells in Defined Culture Conditions
Wing Chang, PhD, Scientist & Steve Szilvassy, PhD, Director, Hematopoietic Products, Stemcell Technologies
Thursday, June 19th, 8-8:30am
Hematopoietic stem and progenitor cells are undoubtedly the most well studied tissue-specific precursor cells and now are commonly used for generating iPSCs. This presentation will describe the isolation, expansion, and characterization of human blood-derived CD34+ progenitors and erythroid cells, and methods for subsequent reprogramming of these cells to iPSCs using defined culture conditions. The tutorial will highlight STEMCELL Technologies integrated workflow for manipulating hematopoietic development in vitro and the generation of iPSCs from these precursors.
Webinar – “Achieving FDA Acceptance and Releasing your Bio Product with Rapid PCR Mycoplasma Testing”
Thursday May 15, 6:00 AM PDT, 9:00 AM EDT
Validation of release methods and approval by authorities can be a lengthy, technically complex and sometimes costly process involving lots of misunderstandings along the way. Mycoplasma is the most common reason for contamination in cell culture and can greatly impact the quality and end-result of cell-based biopharmaceutical products. In this free webinar, Roche Custom Biotech will discuss FAQs asked by regulatory authorities and showcase how Roche Pharma addressed all these questions during validation of the MycoTOOL Test, including the experiments performed and the results that were presented to the FDA.
13th Annual Biological Production Forum 2014 – May 12-14, 2014 – Citywest Conference & Golf Resort, Dublin, Ireland
The 13th Annual Biological Production Forum addresses the need to identify and locate the optimum upstream, downstream & manufacturing excellence solutions whilst tackling the challenges of heightened regulatory pressures. Attend and network with over 100 senior-level pharmaceutical professionals. The agenda is organised around a schedule of highly targeted, pre-arranged 1-2-1 meetings between key corporate buyers and service providers. Each meeting is pre-planned and based on the detailed profile information supplied by each attendee and the sponsors.
World Stem Cells Regenerative Medicine Conference – May 20-22, 2014 – London, UK
Bioconjugates: From Targets to Therapeutics –June 04-06, 2014 · Grand Hyatt Hotel · San Francisco, CA
IBC Life Sciences’ Bioconjugates: From Targets to Therapeutics is taking place June 4-8, 2014 at the Grand Hyatt Hotel in San Francisco, CA. Increase your market share with the latest conjugation design and manufacturing science. This event brings together protein engineers with medicinal chemists in an interdisciplinary forum to foster innovation. Download a copy of the brochure today to see what this year’s event has to offer.
Next Generation Protein Therapeutics Summit –June 04-06, 2014 · Grand Hyatt Hotel · San Francisco, CA
IBC Life Sciences’ Next Generation Protein Therapeutics Summit is taking place June 4-8, 2014 at the Grand Hyatt Hotel in San Francisco, CA. Cross-fertilize ideas from multiple disciplines and turn promising new molecules into differentiated products. This event attracts world-renowned academics and industry visionaries to share ideas, clinical updates, and best practices. Download a copy of the brochure today to see what this year’s event has to offer.
Protein Aggregation, Oligomerization, Stability & Solubility –June 04-06, 2014 · Grand Hyatt Hotel · San Francisco, CA
IBC Life Sciences’ Protein Aggregation, Stability & Solubility is taking place June 4-8, 2014 at the Grand Hyatt Hotel in San Francisco, CA. Reduce protein degradation and safeguard your product’s efficacy with this new scientific meeting dedicated to minimizing protein aggregation from discovery through bioprocessing. Download a copy of the brochure today to see what this year’s event has to offer.
Single-Use Applications for Biophamaceutical Manufacturing – June 09-10, 2014 · Boston Park Plaza Hotel · Boston, MA
Antibody Drug Conjugates 2014 – June 17 – 19 2014, Hotel Fira Palace, Barcelona, Spain
At Informa’s Life Sciences Antibody Drug Conjugateswe’ll be providing scientific-led case studies from over 25 of the leading ADC companies including Genentech, Pfizer, Immunogen, Roche, Takeda, Genmab, Spirogen and more. Discover more about the latest clinical studies from the leading pharmaceutical companies and benefit from:
– Essential data on how to best assess and enhance ADC mode of action
– Establish reliable and reproducible ADC preclinical models
– Seamlessly translate ADCs into the clinic through critical data analysis
Simply quoteCQ3515CCD when booking your place.
Recombinant & Bispecific Antibodies 2014 – June 17 – 19 2014, Hotel Fira Palace, Barcelona, Spain
At Recombinant & Bispecific Antibodies event 2014 we’ll be exploring the latest developments and cutting edge technologies in engineered antibodies, including the latest advances in antibody fragments, antibody domains, ADCs and nanobodies with case studies from Affirmed Therapeutics, National Institute of Health and Cresendo Biologics.
The Recombinant & Bispecific Antibodies conference is part of the Empowered Antibodies Congress, collocated with Antibody Drug Conjugates. Join us to hear preclinical and clinical updates, advances in immunology and expert guidance on how to get your product into the clinic.
Simply quoteCQ3514CCD when booking your place.
BIO International Convention – June 23-26, 2014 – San Diego, CA
Informa Life Sciences’ 7th Annual Viral Safety for Biologicals 2014– June 24-25, 2014 – Pullman Hotel, Cologne, Germany
Informa Life Sciences’ 7th Annual Viral Safety for Biologicals 2014 conference will provide you with the latest technological developments and practical strategies to screen and detect new adventitious agents, optimise viral clearance and implement upstream and downstream viral risk mitigation measures to manage and prevent potential contaminations as quickly as possible.
Informa Life Sciences’ 3rd Annual Biopharmaceutical Raw Materials 2014 – June 24-25, 2014 – Hotel Pullman Cologne, Cologne, Germany
Effective raw materials and supply chain quality management is crucial to ensure appropriate material quality and to enhance the safety and consistency of a pharmaceutical product. Informa Life Sciences’ 3rd Annual Biopharmaceutical Raw Materials is Europe’s only dedicated conference focused on optimising raw material and supply chain quality, with 10+ industry experts and first-hand regulatory advice from Paul-Ehrlich-Institut.
“Germany’s Bayer AG has trumped rival bidders for Merck & Co Inc’s consumer care business in a $14.2 billion deal, adding to a string of major cross-border deals in the healthcare industry. “This acquisition marks a major milestone on our path towards global leadership in the attractive non-prescription medicines business,” Bayer’s chief executive, Marijn Dekkers, said in a statement on Tuesday.”
If you like this story, please see our blog titled “Biologics Still on Top in Best Selling Drugs of 2013”
“UCSF scientists may have found a clever way to use stem cells found in fat tissue to repair or replace bone damage from trauma, cancer or other injuries. The technique, tested in mice with broken shin bones, could improve current bone grafting procedures, which are common but sometimes not as successful as doctors and patients would like. Bone grafting is done to strengthen joint replacements, fuse vertebrae, improve healing of bad fractures or replace bone loss. It involves removing healthy bone from either the patient who needs the graft or from a donor, living or dead. But bone tissue isn’t always available and grafts don’t always work, so scientists have been hunting for techniques to improve or replace the procedure.”
If you like this story, please see our blog titled “10 Things You Should Know About Dry Shippers Before Shipping High Value Biologics”
“Leading global pharmaceutical companies have started to view their vast portfolios of older, established prescription drugs as vehicles for raising large sums of cash to fuel development of new medicines with far higher profit margins. France’s Sanofi (SASY.PA:) and U.S. drugmakers Merck & Co (MRK.N:) and Abbott Laboratories (ABT.N:) are exploring selling off their mature drugs that have lost patent protection, Reuters reported this week, citing people familiar with the plans. Officials at the three companies declined to comment.”
If you like this story, please see our blog titled “CHO Cell Culture – Ten Tips from the Experts on Expression, Media and Bioprocessing”
“Most of these projects have yet to enter clinical development, but the 20% annual increase in the number of biosimilars in clinical trials also indicates substantial advancement in the late-stage pipeline, says the study, from Decision Resources. South American companies have achieved the biggest increase in the number of biosimilars in development, driven by the large number of Productive Development Partnerships in Brazil between public organisations and industry, the study finds.”
If you like this story, please see our blog titled “Highlights from the 14th World Vaccine Congress – A Cell Culture Perspective”
“Organs-on-chips are piling up faster than body parts in Dr. Frankenstein’s lab. Such chips, microfluidic devices that amount to compact, three-dimensional cell culture versions of real organs, already exist for skin, cartilage, bone, gut, artery, heart, and kidney. And that’s not all: scientists anticipate linking together collections of organ chips to create body chips. But such a microfluidic “creature” would require, at a minimum, an artificial circulatory system, which would in turn require a constant supply of fresh blood cells. That’s where the scheme may falter. Unless an in vitro model of hematopoiesis can be developed that is capable of showing all the cellular diversity and complex functions of living marrow, no scientist will ever exult, “It’s alive!” while standing over a newly animated system of organ chips.”
If you like this story, please see our blog titled “Companion Diagnostics – The Power of Personalized Medicine”
“Two new studies out today show both the incredible promise of Stem Cell Research and its current limitations. In one, published in the journal Nature, researchers showed that they could repair damaged hearts by injecting these versatile stem cells into macaque monkeys. Heart disease is the leading cause of death, and if the same process can work in people, it could benefit hundreds of thousands a year. In the other study, published in Science Translational Medicine, five men were able to regrow leg muscles destroyed by accidents or military service. The researchers, from the University of Pittsburgh, inserted into the men’s muscles a “scaffold” of muscle tissue from a pig. Through aggressive physical therapy right after the surgery, the men’s own stem cells were encouraged to populate the scaffold and substantially rebuild their leg muscles.”
If you like this story, please see our blog titled “Aastrom CEO Discusses How Recent Acquisition Strengthens Current Manufacturing Capability and Clinical Pipeline”
“Pfizer Inc. (PFE:US)’s plan to buy AstraZeneca Plc (AZN) probably will lead to billions of dollars in research cuts, the closure of laboratories and thousands of scientists being fired if history repeats itself. While drugmakers routinely refer to “synergies” in proposing large takeovers, the bottom line for patients is often fewer new medicines being pursued, according to a review of past large acquisitions by Pfizer. Since buying Wyeth in 2009, New York-based Pfizer has shed $4.6 billion in research spending, announced plans to close at least seven labs and narrowed its scientific focus to six areas of medicine, ending work in diseases such as asthma and allergies. Pfizer says the changes help make its search for drugs more focused and consumer savvy. Critics contest that the cuts have limited creative, early-stage research and slowed the process of bringing new drugs to market.
If you like this story, please see our blog titled “Flexible Facilities for Biopharmaceutical Manufacturing”