Wednesday, August 27, 2014

What Some Are Calling the “Holy Grail” of Stem Cell Research

Australian researchers have made what some are calling one of the most significant discoveries in the history of stem cell research. 

Thanks to a recent study involving zebrafish, researchers have uncovered how hematopoietic stem cells, one of the most critical types of stem cells, are formed.  These cells, also known as HSCs, are essential in replenishing the body’s supply of blood and immune cells and are key in transplants for patients with blood cancers.  The cells are thought to have the potential to treat a range of conditions because of their ability to transform into muscle, bone and blood vessels. 

An understanding of how these cells develop and regenerate is considered by many to be the “holy grail” of stem cell research and has applications for the treatment of spinal cord injuries, diabetes and degenerative diseases. 

The research team, led by Professor Peter Currie, from the Australian Regenerative Medicine Institute at Victoria’s Monash University, was able to uncover a major part of the cells development—something that had previously been a mystery to scientists.  The team had originally been studying muscle mutations in zebrafish but upon closer examination, they came across something perhaps more significant.  Thanks to transparent larvae of the fish, they noticed that a “buddy cell” appeared to help in the formation of HSCs.  These helper cells, known as Endotome cells, act as a “comfy sofa for pre-HSCs to snuggle into, helping them progress and even become fully fledged stem cells,” explained Currie. 

Currie said the focus of research can now turn towards finding the signals present in Endotome cells responsible for HSC formation in the embryo. 

“Then we can use them in the lab to make different blood cells on demand for all sorts of blood-related disorders,” he said.

While some are in fact calling this discover the “holy grail” of stem cell research, there is still some work to be done.  Said Georgina Hollway of the Garvan Institute of Medical Research in Sydney, “It’s difficult to say exactly how close we are, but we have uncovered a vital step in the process.”


What else is new in the field of cell therapy?  Join us for the Cell Therapy Bioprocessing conference, September 15-16, Boston, MA.  Download the agenda to see what’s on tap.

SAVE 20%* off the standard rate as a reader of this blog. Register here and use code XB14188BLOG.

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Cell Line Meeting Is Just Two Weeks Away - See Who's Attending

IBC's Cell Line Development & Engineering meeting is less two 3 weeks away, taking place on September 8-10, 2014 in Berkeley, CA. 

Don't miss your chance to network with these confirmed attendees who will share their experiences, successes and lessons learned for improving cell line stability, predictability, quality and understanding.  The list includes guests from:

-         -  Merck Serono SA
-         - GlaxoSmithKline
-         - Lonza
-         - Bristol Myers Squibb
-         - Eli Lilly
-         - The FDA
-         - Amgen
-         - Genentech Inc.

Check out the full list here.

If you haven't had a chance to review the 40 case studies and new data presentations on this year's agenda, check it out today.

Register to attend this year's event and gain the practical strategies, best practices and approaches you need to implement today's novel technologies for developing better expression systems for novel modalities and difficult-to-express proteins.  Now you can save 20% off the standard rate* as a reader of this blog.  Register here and use code XB14188BLOG.  

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Highlights from the 2014 Antibody Engineering Agenda

Today, we're giving you highlights from the 2014 Antibody Engineering & Therapeutics Agenda-at-a-Glance:

Sunday Agenda - December 7, 2014
  • Workshop #1 - The Nuts and Bolts of Antibody Development: Accelerating Antibody Drugs to the Clinic
  • Workshop #2 - Advances in Precision Targeting

Monday Agenda - December 8, 2014
  • Keynote Speakers:
    • o James Wells, Ph.D., Professor, Pharmaceutical Chemistry and Cellular and Molecular Pharmacology, UCSF
    • o Ian Tomlinson, Ph.D., SVP, WWBD and Biopharmaceuticals R&D, GlaxoSmithKline, United Kingdom
    • o Douglas A. Lauffenburger, Ph.D. , Professor of Bioengineering, Massachusetts Institute of Technology
    • o Ira Pastan, M.D., Co-Chief Laboratory of Molecular Biology, National Cancer Institute
    • o Anthony Rees, DPhil, Principal, Rees Consulting AB and Emeritus Professor, University of Bath
  • Sessions topics:
    • o Immunocytokine Engineering
    • o The High-hanging Fruit: Targeting Difficult Antigens
  • Day 1 Training Course: Introduction to Antibody Engineering
  • • Opening of Exhibit & Poster Hall
  • • Evening Mardi Gras-themed Networking Cocktail and Food Reception
Tuesday Agenda - December 8, 2014
  • Session topics:
    • o High Quality Research Antibodies against the Proteome
    • o Why is Choosing Targets for Bispecific Antibodies so Difficult
    • o Antibody-based Therapeutics for Diabesity
    • o Preclinical and Clinical Case Studies: Emerging Targets, New Approaches
  • Day 2 of Training Course: Introduction to Antibody Engineering
    • o Evening International Food Festival-themed Networking Cocktail and Food Reception

Wednesday Agenda - December 10, 2014
  • Session topics:
    • o Antibody Effector Functions
    • o New Targets and Applications in Immune Checkpoint Inhibitors
    • o Engineering Antibody Developability Expression, Solubility and Polyreactivity
    • o Emerging Clinical Data with Therapeutic Antibodies and ADCs
  • Special Session of The Antibody Society: Antibodies to Watch in 2015

Thursday Agenda - December 11, 2014
  • Session topics:
    • o Antibody Repertoires: Next Generation Sequencing, Data Analysis, Storage and Sharing
    • o The Best of Both Worlds: Antibodies with Enhanced or Multiple Functionalities
    • o Antibody Therapeutics for Non-Cancer Indications

Take an in-depth look at this year's highlights by downloading the 2014 agenda. Would you like to join us this December in Huntington Beach? As a reader of this blog, when you register to join us and mention code XP14172BLOG, you'll save 20% off the standard rate!


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Tuesday, August 26, 2014

Doctors Take Sides on Biosimilar Naming Issue

Doctors have officially taken sides in the naming rights battle for biosimilars.  In a recent letter to the FDA, a group of physicians has taken the stance that biologic and biosimilar drugs should in fact have unique names.  This letter comes weeks after another piece of mail showed up at the FDA headquarters requesting that the agency not require distinct names for the two types of drugs.  The lobbying is part of a struggle between biologics manufacturers who want to protect their brand equity by requiring separate names and potential biosimilar manufacturers wanting to piggy back off that equity by using the original drug names for their products.

The letter, signed by 23 different physicians, claims that no matter how similar drugs might be, they can cause different reactions among patients with similar diagnosis’ and physical traits.  Distinguishing between the drugs is key and the group feels similar names could get in the way of that.   

Biosimilar naming: Doctors have  drawn a line in the sand“A biosimilar will only be similar, but not identical to the reference product for the foreseeable future. Distinct nonproprietary names will help to alert physicians that each product, while safe and effective, may differ slightly,” the group writes to the FDA.  “Rather than deter physicians from prescribing these products, we believe that allowing physicians to know the exact product that they are prescribing will increase confidence, thus encouraging more robust utilization of biosimilars than may develop without this transparency.”

A recent survey found that in the Europe (where a robust biosimialr market already exists), 61% of physicians prescribing biologics or biosimilars were of the understanding that if two products shared an international non-proprietary name, they were approved for all of the same indications. 

Other lobbying efforts on this policy include a number of petitions submitted to the FDA over the last few weeks.  While the organization has been mum on a possible decision, the market may push their hand sooner rather than later.  Two drug makers are already seeking regulatory permission to sell certain medications meaning that at least one biosimilar could become available next year. 

Until then, the letters and petitions will likely continue to fill the mailboxes at the FDA’s headquarters.

Want more on the latest in the biosimilars industry? Join us for the 15th Annual Business of Biosimilars meeting, October 20-22 in Boston, MA.  Download the agenda to see what else is on tap.

SAVE $100. Register here and use code XP1986BLOG.

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Monday, August 25, 2014

Web Seminar: 3M™ Innovation: Transforming and Redefining Biopharmaceutical Purification with 3M™ Emphaze™ AEX Hybrid Purifier

We're pleased to announce the upcoming web seminar:


3M™ Innovation: Transforming and Redefining Biopharmaceutical Purification with 3M™ Emphaze™ AEX Hybrid Purifier


Speaker: Dr. Alexei M. Voloshin, the Global Scientific Services Leader at 3M
Date: Thursday, September 25, 2014
Time: 2:00 PM - 3:00 PM EDT
Register here. Mention priority code 3MWeb_Blog

About the web seminar:
In this web seminar you will learn about the Emphaze™ AEX Hybrid Purifier - a multi-mechanism clarification device that embodies the philosophy of innovation necessary to transform and redefine the biologic purification process from blood fractionation to viral vaccine manufacturing.

In some processes, such as the monoclonal antibody purification, the unique performance characteristics of the Emphaze™ AEX Hybrid Purifier bring significant advantages to process performance, control, and economics, including the following:
  • -Chromatographic levels of soluble contaminant reduction at the clarification stage.
  • -Enabling the use of 0.1 µm sterile filtration ahead of Protein A column without the use of a pre-filter and with reduced surface area.
  • - Significantly enhanced product purity post-protein A column.
  • - Potential reduction or elimination of aggregate formation at the low pH viral inactivation step.
Emphaze™ AEX Hybrid Purifier is an exciting product made possible by 3M’s 100+ year history in advanced materials research and development. We think that this innovative product will enable our customers and partners to tackle today’s and tomorrow’s challenges in bio-process development.

What you will learn:
  • - Emphaze ™ AEX Hybrid Purifier is a novel multi-mechanism chromatographic qualifier designed to offer significant process wide advantages in a variety of biological purification applications.
  • - Emphaze ™AEX Hybrid Purifier offers high performance clarification including high degree of soluble and insoluble contaminant removal, and significant bio-burden reduction all in one flow-through device. 
  • - In specific processes, such as monoclonal antibody purification from CHO cell culture, the device offers significant advantages such as fixed low turbidity at the outlet of the device and a dramatically increase in purity of the product post protein A.

This web seminar is presented in coordination with BioProcess International Conference and Exhibition.


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Friday, August 22, 2014

Flexible Bioproduction Technologies and Facilities

In today's featured presentation from Biopharmaceutical Development and Producion Week 2014, Thomas Warf, Director, Manufacturing, Facilities and Engineering, BARDA, U.S. Department of Health & Human Services talks about how the government is entering the vaccine industry. He states that the companies have to apply like the vaccine is a commercial product, and talks about how there was almost a pandemic in 2009, and how they delivered more doses of the vaccine for this pandemic than ever before.He also states that this was the first product that was approved for animal trials. To learn more watch the presentation:


Biopharmaceutical Development and Production Week 2015 will take place March 30-April 2 in Huntington Beach, California. For the latest program announcements including the call for speakers and program release, sign up for email updates.


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Thursday, August 21, 2014

Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies.



WWW.COOKPHARMICA.COMOver the past decade, monoclonal antibodies have become mainstream therapeutics for treating a broad range of conditions from autoimmune disorders to cancer. Part of this evolution is increasing time and cost pressure on biopharmaceutical companies to bring new drugs to market. Additionally, companies now routinely engineer and screen molecules for developability and manufacturability during discovery before selecting a final candidate molecule.

The biosimilar development paradigm also demands significantly more bioanalytical analysis during initial cell-line and process development. Thus, a significant investment is being made to assure that molecules entering the pipeline are successful. It is therefore imperative to take an integrated approach to cell-line development and early stage screening and process development. This enables companies to make appropriate, timely decisions about pursuing therapeutic candidates for preclinical and clinical manufacturing.

A critical part of biopharmaceutical development is choosing the right cell line with the objective of confirming cell productivities, cell-line stability, and final-product quality. For a proof-of-concept program outlined herein, Cook Pharmica and Selexis were able to successfully develop a productive cell line, design an efficient process, and scale up a commercially available antibody. Selexis generated the high performance SURE CHO-M cell line that was used in Cook’s rapidly scalable development process at its state-of-the-art CGMP biologics manufacturing facility in Bloomington, IN. Current data from the program demonstrate comparability to the originator drug while achieving commercial-ready titers up to 4 g/L.

Read the full article here.



You can find out more about topics like this and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.



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Wednesday, August 20, 2014

BioProcess International 2014 Symposiums Highlights

In addition to all the programming the BioProcess International conference offers you, IBC has even more programming choices for you by making the five pre-conference symposia available as either an add-on to your 3 or 4 day conference registration, as a stand-alone learning experience, or you can combine with an exhibit hall & keynote pass.

Isn't It Great to Have Choices?  Here are your symposium options for this year:

  1. Antibody-Drug Conjugates - Developing ADC Technologies to Increase Therapeutic Windows: Understand how to apply novel linkers, conjugation methods and payloads to develop, scale up and manufacture next generation ADCs.
  2. Innovation through Integrated Process Development Sponsored by: 3M: : Learn how Innovation through Integrated Process Development provides step change solutions to bioprocesses. Delivering purity to process fluidity leading to process efficiencies and better process economics.
  3. Cell Therapy Bioprocessing: Discover how to successfully develop and manufacture cell therapies and achieve commercial success through technical and process innovations.
  4. Optimize Processes and Improve Raw Materials Continuity and Transparency: Improve your supply chain with the latest techniques to trace your raw materials, better collaborate with suppliers, and troubleshoot the performance of your processes.
  5. Knowledge Management across the Product and Process Lifecycle: Learn how to apply data from your process development and manufacturing operations on an ongoing basis to your next project/run to improve efficiency, quality and control.

Plus, register for the knowledge management symposia and be entered to win a free copy PAT Applied Biopharmaceutical Process Development Manufacturing courtesy of CRC Press.


BioProcess International Conference and Exhibition will take place October 20-23 in Boston.  As a reader of this blog, you can register to join us with priority code BPI14BLOG and save 20% off the standard registration rate.  Have any questions about the symposiums or want to get involved?  Reach out to Jennifer Pereira.


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BioProcess International Poster Preview: Case Studies of hERG Membrane Protein and Japanese Encephalitis Virus Production Using a New Innovative Moving Bed Bioreactor

Leading up to the BioProcess International Event, we'll be highlighting many of the posters you'll be able to find in the hall at the event taking place October 20-23, 2014 in Boston, MA. If you'd like to join us at the event, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate!

Poster: Case Studies of hERG Membrane Protein and Japanese Encephalitis Virus Production Using a New Innovative Moving Bed Bioreactor

Presenter: Lewis Ho,  BioReactor Sciences

About: Human ERG membrane protein has gained great interest as a target for drug discovery. A two fold increased expression of the hERG gene was induced under nutrient limitations. The protein is membrane bound and therefore whole cell recovery from the carriers is required. HEK293 cell was used. Japanese encephalitis virus (JEV) for vaccine has long been the only reliable solution to prevent deadly encephalitis. The virus however is unstable and post-infection conditions for optimal virus production and recovery is critical. We use two case studies to illustrate a new innovative Moving Bed (MB) bioreactor’s unsurpassed versatility and functionality to accommodate specific desired conditions and to accomplish the entire upstream processes in one single bioreactor. The mobility of the moving matrix bed allows for the least amount of volume required for seeding, yielding high seed density resulting in increased cell attachment. Similarly, this feature results in high virus infection and DNA transfection efficiency. The MB system facilitates the principle similar to roller bottles intermittently exposing and submersing cells to air and medium to achieve maximum oxygenation with near minimal shear, and also eliminating foaming issues. The moving bed sets a new precedent in performing the mechanism of cell detachment and recovery in place.

Are you interested in presenting your own findings? BioProcess International is accepting poster submissions through September 19.  For more information and how you can submit your poster to be presented in the poster hall, visit our BioProcess International Poster Page.


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Tuesday, August 19, 2014

FDA Tentatively Approves Lilly's New Diabetes Medication

The FDA has granted Eli Lilly “tentative” approval for a diabetes medication akin to Sanofi’s Lantus.  The drug, to be marketed as Basaglar, is a long-lasting insulin injection that helps to control blood-sugar levels and is essentially a knockoff of the Sanofi version.

The new medication, however, won’t reach shelves for at least 30 months as Sanofi has filed a suit claiming patent infringement.  The drug could hit the market earlier if the court rules in favor of Eli Lilly but is in a holding pattern until then.  Lantus is scheduled to come off of patent February of next year.  This news comes months after Merck divulged plans to develop its own knockoff of the diabetes medication. 

Basaglar has the same amino acid sequence as Sanofi’s drug but for technical reasons is not considered a biosimilar—although for all intents and purposes, it is one.  By European standards, the drug does actually fall under the biosimilar classification and goes by the name Abasria.    

Said Christophe Arbet-Engels, Vice President, Metabolic-clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., "Because of the combined diabetes, development and commercialization experience of Lilly and Boehringer Ingelheim, we are confident that Basaglar, upon final approval, will become a valuable treatment choice for people who need a basal insulin to manage their type 1 or type 2 diabetes."


The biosimilars news is going to keep coming. We’ll have the breakdown of the latest industry updates and trends at the Business of Biosimilars conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.

SAVE $100Register here and use code XP1986BLOG.

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New Antibody Technology and Enhancing Quality

In today's featured interview from Antibody Engineering 2013, Co-founder and Chief Scientific Officer of Larix Bioscience LLC, Bo Yu, talks about how Larix Bioscience had just developed a new technology called the antibody switch. He also talks about some of the companies goals such as streamlining antibody engineering, reducing cost while enhancing quality. In this interview Yu states that one way to achieve this quality is to access this quality in the early stages of development. He also states that one of the trends in the antibody engineering industry is improved product quality.

What is this "antibody switch"? Watch the interview to find out:
 

The 25th Annual Antibody Engineering &Therapeutics Event will take place December 7-11, 2014 in Huntington Beach, California. To find out more about this year’s speakers and topics, download the agenda. If you’d like to join us, as a reader of this blog, when you register and mention code XD14172BLOG, you’ll save 20% off the standard rate.


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Friday, August 15, 2014

Complex Medicines & Global Drug Delivery

In today's featured interview from Biopharmceutical Development and Production Week 2014, Tina M. Larson, Senior Director, Technical Development Operations & Engineering, Genentech talks about the four major opportunities in the drug delivery industry, and challenges in this industry. The four major opportunities include: improving drug-delivery to improve outcomes for patients, developing more complex medicines for patients, improving facility design and improving consistency for these drugs. She states that a challenge in this industry is delivering sophisticated medicines. She also says one opportunity in this industry is to scale these medicines globally. To learn more check out this interview:



Biopharmaceutical Development and Production Week will take place March 30-April 2 in Huntington Beach, California. To stay up to date on the latest about next year's program, sign up for email updates.


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Thursday, August 14, 2014

Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies.


For successful development and marketing of biosimilars with desired efficacy and safety, this industry recognizes the central importance of extensive analysis comparing innovator and biosimilar molecules. It is also recognized in the biotechnology arena that our understanding of complex biologics remains limited even though we have many analytical technologies available to us. A recent FDA guideline for biosimilar development states the following:

The three-dimensional conformation of a protein is an important factor in its biological function. Proteins generally exhibit complex three-dimensional conformations (tertiary structure and, in some cases, quaternary structure) due to their large size and the rotational characteristics of protein alpha carbons. The resulting flexibility enables dynamic, but subtle, changes in protein conformation over time, some of which may be absolutely required for functional activity. . . At the same time, a protein's three-dimensional conformation can often be difficult to define precisely using current physiochemical analytical technology. (2)

With an understanding of our current capabilities in biologics higher-order structure (HOS) characterization, we developed an antibody array enzyme-linked immunosorbent assay (ELISA) to provide a new approach for evaluation of MAb HOS.

In a previous report, we showed that antibody arrays developed specifically toward marketed MAbs could detect structural differences that correlated well with other analytical readouts, including bioassays and glycosylation analysis (8). Experiments have shown that antibody arrays can detect subtle changes that sometimes were not detected by bioassays or any other analytical technologies currently available.

The arrays use more than 30 polyclonal antibodies to cover an entire MAb molecule, thereby measuring its surface-epitope distribution systematically and sensitively, whereas other assays measure only part of the molecule or give an average status of a biologic's population. So antibody array technology should be able to provide a unique measurement of biosimilar MAb HOS comparability. We suggest that additional surface exposure from a baseline readout be termed conformational impurity(8).

Another advantage for antibody array technology is its ability to quantify small amounts of conformational impurity using an easy-to-operate ELISA format. As little as 0.1% conformational differences could be detected from all areas covered by the polyclonal antibodies, thus providing for accurate and sensitive measurement of the status of a MAb's conformation. No data yet correlate the impact of conformational impurity with efficacy and safety of a biosimilar MAb. But it is reasonable to postulate that more conformational impurities (epitope exposures) would increase the risk for potential immunogenicity if those additional epitopes were originally inside the innovator MAb molecule, which has been proven to be tolerated by patients’ immune surveillance systems. A significantly different new epitope exposure could break self-tolerance to a MAb and induce immunogenicity. Furthermore, increased exposure of new epitopes raises the possibility of a biosimilar MAb interacting with other regulatory proteins in a patient's body, causing off-target effects.

Read the full article and see detailed illustrations here.



You can find out more about manufacturing process and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.





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Wednesday, August 13, 2014

Improved Immunogenicity, Rapid Action of Anthrax Vaccine

Soligenix, a company developing vaccines for inflammatory diseases and biodefense, has released results demonstrating improved immunogenicity for VeloThrax™, the company’s anthrax vaccine.

VeloThrax™ is a proprietary recombinant Protective Antigen (rPA) vaccine of Soligenix.  It had been believed that VeloThrax™’s improved immunogenicity could result in a vaccine with the potential to be administered in fewer doses.  Recent results prove that this is in fact the case. 

Immunogenic response vaccine velothrax immunogenicityNext generation anthrax vaccines had aimed for fewer vaccinations over a shorter period of time for both pre and post exposure use.  While the current vaccination requires as many as five administrations over an 18 month period, recent developments with VeloThrax™ show that it’s capable of producing the necessary immune response with only two doses in less than a month’s time.   
The enhanced vaccine was developed by stimulating receptor 4 (TLR-4) which plays an important role in the recognition of pathogens.  The stimulation of these receptors resulted in a boost to toxin neutralizing antibodies and triggered an elevation in immune responses in mice after just one immunization. 

The improved vaccine also proved to be stable at 40 degrees Celsius for up to three months as well as up to 70 degrees Celsius for one month.  This alleviates some of the burden in storing the vaccine. 

“We are very pleased that our enhanced anthrax vaccine, VeloThrax™, has demonstrated promising results indicative of rapid onset of protective immunity," explained Christopher J. Schaber, PhD, President & CEO of Soligenix. "These data demonstrate the potential of creating a rapidly acting anthrax vaccine with the ability to withstand temperature extremes thereby avoiding the need for cold chain management. We believe that stability at such elevated temperatures provides a distinct advantage over other anthrax vaccine technologies currently in development. Further, DNI rPA is highly immunogenic and offers the potential for complete immunization with just one or two doses.”

Schaber says he expects his company to continue to develop the vaccine.  The ultimate goal?  A position as an anthrax vaccine for “stockpiling by the US government”.

Want more on the latest in immunogenicity?  Join us at the Immunogenicity for Biotherapeutics conference this October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

SAVE $100Register here and use code XP1938BLOG.

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1st Annual Women Leaders in Pharma and Biotech Dinner Series

IIR is committed to the support and growth of women in the life sciences industry and after much success with the annual Women's Clinical Leadership Forum at the Partnerships in Clinical Trials conference, we're thrilled to introduce the Inaugural Women Leaders in Pharma & Biotech Dinner Series:

October 20, 2014 | 6:00 – 8:30PM
Omni Parker House | Boston, MA



We invite established leaders and up-and-comers in the pharmaceutical industry — both women and men of all levels — to attend.

Take part in lively and open conversation amongst leaders in the biomedical, bio-technology, diagnostic, health informatics, healthcare, medical device, and pharmaceutical sectors as they discuss strategies to help women work their way up the life sciences ladder.

Don’t forget to check out IIR’s other events in Boston this October 20-22:


Questions? Contact Marina Adamsky


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Tuesday, August 12, 2014

Biologics, Antibody Engineering and Cancer Treatment

In today's featured interview from Antibody Engineering 2013, Jane K. Osbourn, Ph.D., Vice President, R&D and Head of Biosuperiors, Medimmune, United Kingdom, talks about how there were great strides made in biologics for cancer treatment. She states that there the opportunities and challenges are mixed as more technology is moving this field into fruition but brings the challenge of how to spent their resources efficiently.  She also looks at how biologics and antibody engineering can be used for cancer treatment. Watch the interview to learn more:


The 25th Annual Antibody Engineering & Therapeutics Event will take place December 7-11, 2014 in Huntington Beach, California. To find out more about this year’s speakers and topics, download the agenda. If you’d like to join us, as a reader of this blog, when you register and mention code XD14172BLOG, you’ll save 20% off the standard rate.


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Monday, August 11, 2014

Could Gene Therapy Replace the Need for a Heart transplant?

Could gene therapy help avoid a heart transplant?  We’ll soon be one step closer to knowing the answer thanks to a groundbreaking trial in the UK.  Lee Adams, 37, is the first of an eventual 24 patients who will take part in a trial to see if Mydicar, a treatment from U.S. biotech firm Celladon, can help overcome advanced heart failure. 

The treatment is designed to deliver a spike in SERCA2a protein in the heart muscle.  The SERCA2a protein is responsible for making heart muscle contract and low levels have been known to make the heart pump weakly.  The protein will be delivered to the heart via harmless virus.  Researchers plan to take a samples after an initial six month period to measure the presence of the gene.  For those that undergo a subsequent transplant, the researchers will be able to examine the actual heart as well.

Gene Therapy Heart Transplant SERCA2a Protein TreatmentOf the 24 patients the study plans to involve, 16 will receive the actual treatment while the other eight are given placebos.  Like Adams, these patients have advanced heart failure and rely on Left Ventricle Assist Devices (LVAD) to keep them alive while they await a transplant. 

The trial, led by Imperial College London and funded by British Heart Foundation as well as Celladon, claims to be the first in the world to investigate the use of gene therapy to correct heart failure. 

Says Professor Sian Harding, who helped develop the treatment, “It's important to remember that the therapy is not correcting a gene defect. We are working much more downstream, which means that no matter what the cause of the heart failure, the therapy should be equally beneficial for patients whether their heart problems stem from genes, lifestyle or the environment or a mixture of all of these."

Adams has a reserved optimism towards the study.  "Of course the best thing that could happen would be for my heart function to show signs of improvement and for the gene therapy to prove to be a 'miracle cure' for myself and other patients. But I'm not building up my hopes too much because, for all I know, I might have had the placebo.”

Here’s to hoping it is the “miracle cure”.

What else is new in the field of cell therapy?  Join us for the Cell Therapy Bioprocessing conference, September 15-16, Boston, MA.  Download the agenda to see what’s on tap.

SAVE 20%* off the standard rate as a reader of this blog. Register here and use code XB14188BLOG.

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Biosimilars Can Save Money and Lives. Why the Delay?

Biologic drugs are used to treat a number of serious, life threatening diseases and save countless lives.  They are, however, exceedingly expensive.  The average daily cost of a biological in the U.S. ($45) dwarfs that of chemical drugs ($2).  Annually, some of these drugs can cost patients as much as $400,000.  The question becomes “how do we make these treatments more sustainable?”  The short answer to that question centers around biosimilars as one study estimates they have the potential to save north of $250 billion from 2014 to 2024. 
 
The long answer to that question, however, is not as straight forward.  Manufacturers of biological drugs can continue to charge monopoly prices as long as those drugs remain under patent protection.  Even as these medications begin to come off patent, many over the next few years, the road for biosimilars to enter the market is not exactly paved.  While many other countries (Australia, Canada, and the EU specifically) have had a market for biosimilars since 2006, the US policy for entry of these drugs remains ambiguous. 

Biosimilars Money Savings Patients FDA Cost Drug Biologics
A big part of this delay can be attributed to the FDA’s lack of progress in establishing guidelines for the approval of biosimilars.  Although they did accept their first biosimilar application last week, there still lacks a definitive set of regulations.  Tentative guidelines had been provided both in 2012 and 2014 but a final set is still in progress. 
This uncertainty in the regulatory process has caused apprehension among many drug companies and left fewer players vying for a place in the market.  Said one pharmaceutical executive, “I would like absolute clarity before we make a large investment. The quality of the decision is worth more than speed.”

While the FDA wavers in putting a process in place, biologics manufacturers have engaged in stall tactics.  The longer biosimilar drugs stay off the market, the longer these companies can continue to enjoy massive profits—reportedly as much as $100 million a month for some drugs.  The latest strategy employed involves disputing the naming system to be put into place for these drugs.  Biologics manufacturers have lobbied to maintain separate names, and the equity that goes with those names, from competing biosimilars.

While this dispute carries on, patients are missing out on billions of dollars in savings.  Many have called for the FDA to re-calibrate their priorities and fast track a set of guidelines that would allow biosimilars to hit the market sooner.  Other countries have had regulations in place for almost eight years while we wait for officials to perfect ours.  Until then, drug companies will continue to pad their pockets with massive profits from these drugs.   

Biosimilars is projected to be a lucrative industry. Can you afford to miss out? We’ll have the latest industry news and trends at the Business of Biosimilars conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.

SAVE $100Register here and use code XP1986BLOG.

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Inside BioProcess International: Kenneth Green, Ph.D., Director, Global Technical Services, Pfizer

BioProcess International Magazine is releasing a series of podcasts over the summer to prepare for the BioProcess International Conference and Exhibition taking place this October in Boston. Next up in our exclusive podcast series is an interview with speaker Kenneth Green, Ph.D., Director, Global Technical Services, Pfizer.

In his interview, Dr. Green discusses the common risks of raw material with cell cultures, how vendors control risk management for raw materials and how predictive modeling can affect risk management of raw materials.


Dr. Green will be at the BioProcess International Conference and Exhibition on Thursday, October 23 to present The Application of Risk Assessments to Identify and Mitigate Material Risks.  To find out more about his presentation and the rest of the agenda, download the brochure here.  If you'd like to join us October 20-23 at the event in Boston, as a reader of this blog, when you register to join us and mention BPI14BLOG, you can save 20% off the standard rate.


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Thursday, August 7, 2014

Stay cool this summer with a 25% savings! Register by August 15 and save 25% off the standard rate!

Register now to get your cool savings off IIR’s 15th Annual Business of Biosimilars event with a 25% discount off the standard rate!*


Register here to join us and mention code XP1986Cool to take advantage of this discount.

The Biosimilars event will take place October 20-22, 2014 in Boston, MA, visit the website for full details.  
Download the agenda here to see what’s on tap.

Have any questions? Email Mike Madarasz.


Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn


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