Showing posts with label research. Show all posts
Showing posts with label research. Show all posts

Friday, December 4, 2015

Antibodies as Drugs: A Lesson from Before the Antibiotic Era

This post was contributed by Twist Bioscience


'His penicillin will save more lives than war can spend’ was the tagline accompanying a serious-looking Alexander Fleming on the cover of the May 15th, 1944 issue of TIME Magazine. With his discovery of penicillin came the antibiotic era of medicine. However, when one giant rises, another must fall. Serum therapy was, almost overnight, systematically dethroned as the accepted treatment for infectious diseases.

The cover of the May 15th 1944 issue of TIME magazine, which features Alexander Fleming shortly after his discovery of Penicillin. Source.

Serum therapy, the treatment of an infectious disease by injection of an immunized animal’s blood serum, was first used to cure disease in the 1890s. In the 40 years it took for penicillin to be discovered, serum therapy treated a swath of diseases including tetanus, diphtheria, measles and chicken pox.

By inoculating an animal with a dead pathogen, the animal’s antibody-rich immune sera could be extracted. Injecting the immunized animal sera into patients lead to prophylactic, bactericidal, antitoxic and protective benefits. However, it would take around six months to develop a serum, and even then only around 40% of patients would show improvement, making antibiotics were a better solution1.

Today, with the threat of antibiotic resistance looming, antibody treatment is reinstating itself into the next era of medicine. Significant developments that enable us to mass-engineer an antibody’s binding domains have occurred in recent years. Our ability to screen candidates for highly efficient binding, and grow them into concentrated sera of monoclonal antibodies has also drastically improved.

With this, antibody therapy has become accepted into routine clinical practice. Antibody research is now at fever pitch, with thousands of published clinical trials on PubMed today.

Monoclonal antibodies have incredible potential in disease and disorder treatment, due to their ability to explicitly bind specific molecules. The immunosuppressant Muromonab-CD3, given to organ transplant patients, was the very first to be approved by the FDA for human use in 1985. Since its approval, many monoclonal antibodies have now been cleared for use, or are advancing through clinical testing. Disease targets include Crohn’s disease, cancer, asthma, psoriasis, diabetes, HIV, influenza and Alzheimer’s disease.

Importantly, antibody-based therapies are moving toward completely humanized monoclonals (as opposed to those sourced from mice). Research focuses on engineering low toxicity, high target specificity and improved manufacturability – all characteristics bolstered by the advent of synthetic biology, especially massively multiplex DNA libraries.

These vast libraries contain around 1010 different antibody sequences, representing every possible combination of mutations at particular points within an antibody’s variable regions. The single set of mutations that confers perfect, high-specificity binding to an antigen of interest can then be fished out with a number of high throughput screening technologies. Such advancement has been pivotal to antibody therapy research, pushing engineering costs down, reinforcing efforts to treat complex diseases with global reach, such as cancer.

The many ways an antibody can be engineered to destroy a tumor cell. Source: (Chao et al., 2012)

In addition to DNA libraries, advances in next-generation sequencing-based diagnostics have opened new avenues for targeted, personalized, antibody-based therapies. By sequencing a tumor biopsy, it is possible to identify specific cancer-related surface antigens that are overexpressed – known as the ‘oncotype’ of the patient’s tumor. The corresponding antibody treatment can then be administered.

One well-known example of a cancer-treating, FDA-approved monoclonal antibody is Herceptin – for treatment of HER2-positive (HER2+) breast cancer oncotypes. In a large fraction of aggressive breast cancers, HER2 is overexpressed causing accelerated cellular proliferation. Herceptin targets HER2 receptors, blocks their signaling pathway, and attenuates tumor growth and proliferation. In a 10-year study of 4,000 women with early-stage HER2+ breast cancer, treatment with Herceptin showed a 37% increase in overall survival and a 40% increase in disease-free survival compared to a cohort treated only with chemotherapy2.

A vial of the breast cancer fighting, monoclonal antibody - Herceptin. Source.

Herceptin binds specifically to its cancer-specific antigen, however, oftentimes antigens are shared between cancer and some of the body’s own cells, causing the destruction of healthy tissues.

Yvonne Chen of UCLA, who spoke at the recent 2015 Synthetic Biology Congress in London, discussed her research on integrating synthetic biology and antibody engineering to solve this problem. Her group engineered antibodies to contain additional binding domains – so one antibody will only have strong binding if two antigens are present. This ensures the antibodies exclusively bind to a specific cancer cell.

Synthetic biology tools are revolutionizing high-throughput antibody engineering. As the cost of writing DNA decreases with new methods of DNA synthesis, the speed of development will increase. Simply, pharmaceutical and biotechnology companies will be able to test more options to improve specificity and manufacturability. In turn, this will enable highly targeted and highly beneficial therapies for the hardest-to-treat diseases, which can be delivered to patients worldwide.



About Twist Bioscience
At Twist Bioscience, our expertise is synthetic DNA. We have developed a proprietary semiconductor-based synthetic DNA manufacturing process featuring a 10,000-well silicon platform capable of producing synthetic biology tools, such as oligonucleotides, genes, pathways, chassis and genomes. By synthesizing DNA on silicon instead of on traditional 96-well plastic plates, our platform overcomes the current inefficiencies of synthetic DNA production, and enables cost-effective, rapid, high-quality and high throughput synthetic gene production. The Twist Bioscience platform has the potential to greatly accelerate the development of personalized medicine, sustainable chemical production, improved agriculture production as well as new applications such as in vivo diagnostics, biodetection and data storage. For more information, please visit www.twistbioscience.com. Twist Bioscience is on Twitter. Sign up to follow our Twitter feed @TwistBioscience at https://twitter.com/TwistBioscience.






1. Glatman-Freedman, Casadeval. Serum Therapy for Tuburculosis Revisited: Reappraisal for the Role of Antibody-Mediated Immunity Against Mycobacterium Tuburculosis. Clin Microb Rev. 1998.

2. Perez et al. Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831. J. Clin. Oncol. 2014.


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Tuesday, October 27, 2015

Last Chance to Submit a Poster for Antibody Engineering & Therapeutics

As a reminder, there is only one week left to submit a poster presentation for this year's Antibody Engineering & Therapeutics meeting, held December 7-10, 2015 in San Diego, CA. If you haven't submitted a poster yet but would like to present one, be sure to submit your poster abstract by Friday, October 30th.

By presenting a poster, you will:

• Push Your Research Project Forward
Gain fresh ideas and new perspectives to accelerate your current project by hearing 100 academic and industry presentations covering the latest antibody research and therapeutic programs.

• Premier Networking Opportunities..Make New Pharma/Bio and Industry Contacts
Forge scientific collaborations with world renowned researchers during a variety of networking opportunities-last year over 700 attendees from around the world were in attendance. And 75% of attendees are from companies you need to meet with, so if you are looking to make pharma/bio contacts with whom to discuss your research programs, this is one event you will not want to miss.

• Free Posters for Academic Attendees to Present Your Research
Any registered academic attendee may present a research poster during the event at no additional charge-share updates from your current research project with this global audience.

• Gain a First-Hand Look at New Technologies in Our Exhibit Hall
Visit 50+ different exhibit booths and experience a first-hand look at the newest technologies that can accelerate your current research projects.

Not only will you be able to showcase your research, but you will gain face-to-face time with other presenters and industry scientists during the dedicated poster viewing times. Take advantage of the dedicated "stand by your poster" viewing times to ensure you can connect with other poster presenters to discuss research experiences and results. Click Here to Submit Your Poster Abstract for Approval. The deadline for poster submissions is this Friday, October 30th-so hurry!

We look forward to welcoming you in San Diego this December!


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Thursday, October 15, 2015

Biotech Halfway Around the World

By: Frank Cordon, Senior Director of Growth Services, New England Controls

If you were to Google “biotech hubs,” cities like Boston, San Francisco, and San Diego would certainly be first on the results page.  These centers cover our industry from early stage cutting-edge research through the highest levels of full scale manufacturing.  For those of us in the industry a bit longer, we would expect to see  centers in the Carolinas, the Midwest, the United Kingdom and smaller clusters in France, Germany, Belgium, and Denmark show up on pages 2 and 3.  With our western biases we would tend to think much less about Asian locations as full-fledged biotech centers.



Last month, I had the opportunity and great pleasure to assist in a gap analysis project for a biotech plant in Singapore.  This was my third trip to this wonderful city state in the last 10 years.  Once again, I was very impressed with the manufacturing professionals I worked with.  Not only were they excellent technically, but more impressive was their commitment to their work.  With a 12 hour time difference to the east coast USA, it’s never a good time to have a conference call or video conference.  Yet, my Singaporean counterparts are the first to offer to stay up late into the evening to accommodate a meeting at 9 or 10 or 11am Eastern Time.  I would invariably have to twist their arms to agree to a 6am or 9pm EST call so they aren’t the only ones working outside of the normal work day.

As I was flying back, I was able to reflect on the experience - and yes it’s a long trip so there’s plenty of time to reflect – and came away with a sense that the people of Singapore see high tech manufacturing and life sciences, in particular, as a strategic imperative to the long-term health of their country.  This commitment is apparent with the building boom occurring in the Tuas area of the island which is where most, if not all, of the biotech plants reside. 

During my first couple of trips, I was made aware of the strength of biotech manufacturing in Singapore.  What I didn’t realize until I attended the BioProcessing International Conference & Exposition (BPI) in Boston  in 2013, was the depth of the innovation culture and the progressive research and development commitment to the industry that companies and people in Singapore truly have.  During that 2013 conference, I attended several sessions where researchers from the Bioprocessing Technology Institute of Singapore presented their work.  Over the past 2 years, there have been so many news-worthy announcements coming out of Singapore; Medical school partnerships with Duke University and the Imperial College of London and R&D centers like the Novartis Institute for Tropical Diseases have been built to name a few. There are over 30 major R&D centers on the island (www.pharmaphorum.com – February 2014) with new announcements coming out weekly.  The pace of growth has led to a real talent shortage as reported last week on Biotechin.asia. 

You can imagine that as I browsed the program for this year’s BPI Conference & Exposition, I was pleased to see that the Bioprocessing Technology Institute of Singapore is being represented yet again.  With representatives from Amgen Singapore and other Asian-based biotech companies, speakers represent the tremendous growth of our industry in Asia.  When combined with presentations from colleagues based in Europe and the Americas, BPI is truly a global gathering. So, if you haven’t gotten the opportunity to travel halfway around the world to visit these world-class facilities, you’ve got to make it to Boston from October 26-29th for the 2015 BioProcessing International Conference and Exposition. I hope to see you there.


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Friday, June 26, 2015

This Week in BioPharma: 6/22-6/26

Here is the top news from the biopharmaceutical industry this week:

Organic Industry Wants Biotechnology Regulated By Process, Not Product: About 40 activist organizations that usually can be counted upon to rally with the organic industry against genetically engineered (GE) plants and animals weighed in with a letter to USDA’s Animal and Plant Health Inspection Service (APHIS) for the federal regulation of biotechnology products. Monday’s letter, which included some food company signatures as well as those from organizations, called for APHIS to “regulate biotechnology based process, not product.” The letter also called for adding noxious weeds to biotechnology regulations, which the signers want regulated to the “fullest extent.”

Saudi Engineer Invents Unique Biotechnology: Saudi engineer and inventor Ibrahim Alalim has 
come up with a new biotechnology to break down the composition of any animal fat, crude oil or any petrochemical product. “This biotechnology involves a liquid extract from vegetables that could be instrumental in coming up with products that will be useful in cleaning utensils, floors and marble,” Alalim said.

These are the Fortune 500's Fastest-Growing Pharma Companies: The pharmaceutical industry has been rocked in recent years by a confluence of patent expirations of blockbuster drugs, increasing competition from generics and new governmental and industry efforts to control costs the world over. That’s made growth prospects for many pharma companies a risky and uncertain proposition. 

The Importance of Real-World Data to the Pharma Industry: For years, randomized controlled trials (RCTs) were considered the gold standard for generating clinical data on efficacy and safety to support product registration and subsequent prescribing. Recently, analysts and academics have discussed the promise of real-world data (RWD), signalling its potential to contribute to improved health outcomes. Data's role in normal clinical practices, or in settings that reflect the reality of healthcare delivery, is likely to become increasingly important in ensuring that medicines are accepted by national policymakers and are adopted into practice.

Is the FDA Too Tough on Medical Device Makers?: In a new paper, “Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices,” Wharton health care management professors Matthew Grennan and Robert Town shed light on the question: Are the FDA’s medical device regulations too hard, too soft, or just right? Town recently sat down with Knowledge@Wharton to discuss their findings.

House Ignores Veto Threat and Backs Repeal of Medical Device Tax: The House on Thursday easily backed repeal of a tax on the medical device industry. But President Obama has threatened to veto the bill, which would add more than $24 billion to the deficit over the next 10 years. With not all House members voting Thursday, that chamber's 280-140 vote fell one vote shy of a veto-proof majority to repeal the tax, which helps pay for the expansion of health insurance under the 2010 Affordable Care Act.


Short Sellers Become More Focused on Big Pharma: The short interest data has been released for the June 15 settlement date. Pharmaceutical companies are usually involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be big upside.


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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.

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