Microarray Solutions / edition #8



Contract Microarray Printing Feature

To increase accuracy and reliability, and to reduce the costs per sample of microarray testing, new platforms are essential. Commercial platforms, like contract array manufacturers, have been established to fulfill this need and prepare microarrays with a variety of different probes.
The NEXTERION® team has interviewed a few of the most prominent microarray contract printers with whom SCHOTT has developed excellent partnerships in recent years.

Our Interview partners were:

Applied Microarrays Inc.
Microarrays Inc.
Scienion AG



Applied Microarrays Inc.

7700 South River Parkway
Tempe, AZ 85284
USA
www.appliedmicroarrays.com

Interview partner:
Stacey Clarken, Ph.D.
VP of Commercial Operations


Describe your company, its core competencies and mission
Applied Microarrays (AMI) is a contract manufacturer of protein and DNA microarrays for diagnostic and research applications. We provide creative solutions in microarray design and manufacture by combining the diverse individual abilities of our team and 10+ years of experience working together. Our mission is to be the world-leading microarray manufacturer by combining our proprietary spotting technology, extensive background in array optimization, and quality systems backed by ISO certification.

What distinguishes your company from other contract printers?
AMI utilizes proprietary non-contact printers that offer flexibility, precision and control that we have not seen elsewhere in the market. We have the engineering and scientific experience to meet a wide variety of custom requirements such as environmental control for sensitive materials (i.e. lysate arrays) and custom sized substrates (i.e. silicon chips). Our high capacity facility has the flexibility to build small development print runs up to large-scale production. Our services are comprehensive and include the control of upstream raw materials, manufacture and testing of companion reagents, custom labeling and packaging as well as logistics.

What trends have you noticed in the field of microarrays in the past few years?
We have seen significant growth in protein-based arrays, with capture probes ranging from antibodies to peptides to cell lysates. Some customers have indicated that the expressed protein is more relevant for their assays and, of course, the ease of sample prep compared to nucleic acid isolation and amplification makes protein arrays attractive as well. Optimization of protein arrays requires an understanding of the parameters that affect protein attachment to the substrate, in which we have a strong knowledge base.

Is your company developing products for the diagnostic market?
AMI manufactures diagnostic products for our customers that are bringing their products to market. By using our established manufacturing facility and taking advantage of our other services such as array optimization and functional QC of the final product, our customers accelerate their presence in the market. Furthermore, our ISO 9001 and ISO 13485 certification ensures the quality and traceability that is required for our customers’ entry into diagnostic applications.

How do you perceive the market potential for multi-well and plate-based microarrays?
In the last year we have seen increased interest in the use of multi-well and microtiter plate arrays for several reasons. Some diagnostic and research applications require the testing of hundreds or thousands of samples at a time and the multi-well formats meet this high throughput need. Liquid handlers are compatible with these formats and that allows for automation of the array processing. The low cost of arrays in these formats opens up new markets for our customers as well; the efficiency of printing many arrays at once brings our price to the customer to <$10 array in multi-well formats. With these advantages, we see significant market potential for these higher throughput formats.

What strengths do you feel that the SCHOTT NEXTERION® portfolio of products offers to researchers and diagnostic companies?
The high quality of the NEXTERION® products and readily available technical support reduces the time we spend in optimization of substrates. Another important aspect of your portfolio is the availability of slide and plate formats for each substrate type, which helps our customers transition to the throughput that suits their projects and target markets.



Microarrays Inc.

601 Genome Way, Suite 3300
Huntsville, AL 35806
USA
www.microarrays.com

Interview partner:
Joel Peek


Describe your company, its core competencies and mission
Microarrays, Inc. originated from the Vanderbilt-Ingram Comprehensive Cancer Center in Nashville, Tennessee. In response to the growing expertise, proficiency and printing innovations developed at the Cancer Center, Microarrays, Inc. was established as an autonomous company in November of 2000 and has been privately held since May of 2010.
MI’s corporate mission is to advance array-based technologies for biological research, detection and diagnostics. In diligent pursuit of this goal, MI has progressed to the forefront of development and commercialization of array-based technologies. In an effort to build additional capacity and foster collaboration, MI relocated to the Hudson-alpha Institute for Biotechnology (HAIB) in Huntsville Alabama in May of 2008.
The HAIB was founded with an objective of developing and using biotechnology to further personalized medicine. MI’s technology fits well within this objective; moreover we’ve found the environment fostered at the HAIB to be invaluable for our growth and product development. HAIB is comprised of individuals from a wonderful diversity of disciplines, including world-class researchers, manufacturing and business. Access to these formidable talents is a great resource, one that rapidly accelerates both the development and market entry of our products.
MI mainly produces array-based products that are used as biological research tools or disease diagnostic products. Arrays are manufactured in HEPA-filtered, environmentally-controlled clean rooms following Good Manufacturing Procedures. Microarrays has over 10 years experience in developing products arrayed on a variety of surface types, including products based on DNA, protein, peptides, antibodies, lysates and lectins, etc. These products encompass a wide range of commercial and research applications including expression profiling, bio-defense, infectious disease diagnostics, immuno-profiling, and bio-marker discovery.

Is your company developing products for the diagnostic market?
To improve healthcare, MI is focused on the development of low-density DNA and protein arrays for diagnostic applications. Microarray-based diagnostic products are some of the most technical and customized products that MI makes. We have worked extensively and successfully with several organizations to develop array-based diagnostic and monitoring products. These products encompass a wide range of applications including infectious disease diagnostics, pathogen detection, prognostic expression profiling, autoimmune disorders, etc. Diagnostic arrays have applications such as sub-typing cancers to better direct therapies, as well as the identification of viral and bacterial pathogens within patient samples. Arrays can provide clinicians with valuable information, resulting in significantly improved patient outcomes. MI’s array technology offers to enhance diagnostic function as well as provide an accurate and affordable platform to detect disease.

What distinguishes your company from other contract printers?
Customer service and innovation are what separates MI from the crowd. From the inception of any project, MI personnel work closely with our clients to assure that their needs are met. This is typified by many of our commercial clients who have an especially wide range of formatting, substrate and fabrication requirements. Unlike most other contract printers, all of the MI software and printing machinery are developed in-house by our engineers and are readily modified to accommodate any desired printing need. Our technical plasticity and design accommodation greatly reduce the challenges associated with new product development or a custom array project.

What trends have you noticed in the field of microarrays in the past few years?
Over the last several years our business has seen a rapid expansion of two key areas, namely protein arrays and as mentioned earlier, diagnostics products. Expectedly, for protein arrays there has been a natural migration from nucleic-based to protein-based research for many areas.
Protein arrays are a powerful means to assess protein-protein interactions, monitor protein expression levels or determine the presence or amount of target analytes in biological samples. Protein arrays are commonly used for parallel multiplex screening of protein associations with ligands, analytes, discovery of drug target pathways, as well as the identification of biomarkers for infectious disease, autoimmune disorders, and cancer. Arrays offer the advantage of high sensitivity, multiplexing, high-throughput capacity, as well as speed and low cost.
To this end, MI provides an affordable, exceptionally accurate protein-based analysis platform using peptides, proteins, culture/cell lysates, antibodies, and small molecules.

What sorts of services can you provide to laboratories, and what benefits can they expect from working with your company?
MI mainly provides services within the areas of custom array fabrication, commercial Original Equipment Manufacturing (OEM) and new product development. For custom services work, we utilize client-owned probes to fabricate specialty arrays designed specifically to meet the client’s unique needs and specifications. Custom services range from complete array design to existing platform replication, and everything in between.
For OEM manufacturing, we are typically working with a commercial client who has a late stage product that must be manufactured to an exacting set of specifications and tolerances. MI works with the client to design manufacturing and validation parameters, which match their market requirements. These products are often very specialized and typically must conform to the manufacturing standards of external control and regulatory agencies.
MI also provides a spectrum of product development services to commercial clientele, ranging from start-ups to Fortune 500 companies. These contractual services span all aspects of early, middle and late stage product development. MI is very proficient at taking early stage intellectual property through a rigorous process of platform design, optimization, validation and regulatory control. Regardless of the client’s level of need, the staff at MI always provides a personal, accessible partner willing and able to address every aspect of array technology and platform development. MI helps remove the challenges associated with new projects via expertise and knowledge, and through innovation and creative problem solving.

What strengths do you feel that the SCHOTT NEXTERION® portfolio of products offers to researchers and diagnostic companies?
At MI, we utilize a broad range of arraying attachment chemistries, due to the diversity of our clientele. Fortunately, SCHOTT NEXTERION® simplifies our task by offering an equally diverse range of surface chemistries within their product line. When approaching a new project we can be confident that SCHOTT NEXTERION® will have an optimal surface for our needs. Likewise, in recent years more and more of clients are using high throughput systems and SCHOTT NEXTERION® offers an excellent line of multi-assay products in both slide and plate formats. Our clients have found these systems to be especially useful and convenient. Most importantly, in working with SCHOTT NEXTERION® we have found their people to be an invaluable source of information and assistance throughout any project, from the conceptualization phase, right through to completion. In addition, SCHOTT NEXTERION® has been a wonderful development partner for our company by responding with proficient solutions to some of the more specialized commercial needs of our diagnostic and OEM clientele. Lacking their timely, creative solutions, some of these projects would have been significantly more challenging. Without hesitation we are able to trust our needs to SCHOTT NEXTERION® and their very qualified staff.



Scienion AG

Volmerstraße 7b
12489 Berlin
Germany
www.scienion.com

Interview partner
Guenter J. Bauer


Describe your company, its core competencies and mission
Scienion AG is a life science company well positioned in the markets of ultra low volume liquid handling systems and microarray technologies. Scienion AG provides systems and services for dispensing biological and chemical agents for diagnostics, pharmaceuticals, veterinary, plant and food analytics and research. Scienion’s dispensers, the sciFLEXARRAYERs, allow for non-contact and precise drop spotting in the pico- to nano-liter range and are optimally suited for microarray based analytics – as for tests with DNA, oligonucleotides, peptides, proteins, antibodies, glycans or for dispensing cells onto various carriers. Our integrated product portfolio has been consequently expanded over one decade in order to facilitate and improve multiparallel bioanalytics, high throughput screening and high throughput production of microarrays in the genomics and proteomics fields – from early research to manufacturing.

What distinguishes your company from other contract printers?
Scienion’s contract services support customer from the first idea to the final product. Our sciService includes contract development and array manufacturing for customers in pharmaceutical, biotech, diagnostic, and reagents companies. Contract development of tailor-made array applications on customer-specific supports ranges from support functionalization, printing, probe immobilization, target incubation to data analysis. Printing of any kind of biomolecule on any kind of target surface is enabled by Scienion’s sciFlexarrayer technology. Arrays with superior spot morphologies and accuracy are printed onto slides and biosensors as well as into microplates with more than 100 spots per well. Like no other, Scienion’s technology can easily be transferred from R&D feasibilities to large scale ISO-certified high throughput production. 3) What geographic markets does your company cover? Scienion is selling worldwide and has distributors in the US, UK, Italy, France, Switzerland, Singapore, Malaysia, Indonesia, South Korea and Japan.

What trends have you noticed in the field of microarrays in the past few years?
Scienion sees a strong need for miniaturisation and parallelization of diagnostic tests driven by the need to save costs and to develop competitive next generation products. Array-based solutions for diagnostic applications represent a significant segment within this trend. We also see an increasing demand of low-density microarray applications, especially in microplates, that can be combined with low-cost read-out methods as colorimetric detection. Miniaturized assays in the microarray format within a single well of a microplate can be used for multiplexing of assays allowing significant cost reduction in diagnostic applications.

Is your company developing products for the diagnostic market?
Scienion is enabling its customers to develop products for the diagnostic market in a very cost efficient and fast manner. As a contract manufacturer for IVDs, Scienion’s non-contact printing technology is becoming a kind of reference in array production.

What strengths do you feel that the SCHOTT NEXTERION® portfolio of products offers to researchers and diagnostic companies?
SCHOTT NEXTERION® is offering quality products at affordable prices. High quality and low batch variations are keys for a stable production process. SCHOTT NEXTERION®’s high quality functionalized slides can be used for a broad range of array-based applications that include immobilization of a diversity of biomolecules as DNA, proteins, peptides, glycans and cells.