Catalent Scientist’s Article Featured by Biotechnology Industry Organization

An article written by Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, was featured in the Biotechnology Industry Organization’s (BIO) March 2009 e-Newsletter. The article, titled “A Guide to Accelerating Bioassay Transfer in the GMP Environment,” highlights important questions and steps to set timelines and prepare for a successful bioassay transfer. Dr. Menendez’s work, along with a number of articles written by industry leaders, is being offered for free download on BIO’s website – www.bio.org.

According to Dr. Menendez, “Setting realistic timetables, creating thorough documentation to transfer bioassays between organizations, and working with a highly qualified CRO are the keys to streamlining the production of biologics and accelerating their time to market.” Her article goes on to provide guidelines to help increase clarity in setting timelines, along with illustrative case studies where delays could have been avoided.

As part of Catalent’s Respiratory, Analytical and Biotechnology group, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Dr. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Dr. Menenedez is an international instructor on Bioassay Development and Validation and a frequent speaker at biopharmaceutical conferences.

About Catalent
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,100 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

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LC Sciences’ Versatile Microfluidics Chip Technology Extended to Target Selection Applications

LC Sciences has announced the availability of a custom target enrichment service for next-generation sequencing applications. LC Sciences now provides a service for Target-Specific Selection of a defined genomic region (such as Mbp region at a specific location, suspected cancer regions, SNP regions, regions for genomic comparisons) or RNA sequences (such as sets of transcriptome sequences known f r o m previous screening experiments, mRNAs, and miRNAs). This new service enables researchers to take full advantage of new “next-generation” high throughput sequencing technologies.

It is clear that these new sequencing technologies can be more effectively utilized for systematic studies of genetic variation by targeting certain specific regions (subsets) of complex genomes. Essentially, our service achieves more coverage and deeper sequencing by reducing sample complexity and focusing reads on the areas of interest.

LC Sciences µParaflo® technology’s unique combination of advanced microfluidics and innovative synthesis chemistry provides a robust synthesis process which is necessary to achieve high quality selection and the flexibility to handle almost any target selection project. This technology has been used to produce custom sequence microarrays [Nucleic Acids Res. 2004,32,5409] and custom designed oligonucleotide mixture libraries (OligoMix®) [Nature. 2004,432,1050] since 2003 and is now particularly well suited to providing target selection solutions. The versatility of the technology makes it a good fit for the diverse needs of researchers embarking on new high-throughput sequencing projects.

“It’s really the flexibility of the technology that sets it apart f r o m others”, says Dr. Christoph Eicken, Head of Technical Services, Microarrays. “First, this is a completely custom synthesis technology, meaning almost any selected genomic region of any species and all known RNA transcripts can be targeted. Second, target selection may be achieved by hybridization using complementary capture probes immobilized on surface or by in-solution hybridization. By altering the target selection approach we take, we can address the widely varied needs of each individual sequencing project. With our help, researchers can tailor design the target selection process based on the specificity, coverage, selection resolution and throughput requirements of their particular project.”

LC Sciences’ microarray based approach utilizes thousands of custom oligonucleotide sequences which are synthesized in situ on a programmable high density microfluidics chip as capture probes designed to target specific regions of interest in any genome (or transcriptome). Samples are hybridized to the chip, undesired sequences are washed off and the captured target sequences are recovered by eluting them f r o m the chip. The selected target sequences are ready for high-throughput sequencing or further processing.

When target selection in-solution makes sense, this flexible chemistry can directly synthesize biotinylated or phosphorylated oligonucleotides (capture probes) that are designed to target specific genomic/sequence regions of interest. After hybridization with a sample, magnetic beads are added and the capture probes are affinity linked to the beads. The captured target sequences are separated f r o m other sequences by washing the beads after which the target sequences can be recovered. Alternatively, the oligonucleotides (OligoMix®) may be immobilized on beads prior to target selection, again depending on the needs of the particular project.

LC Sciences currently offers its Target-Specific Selection application as a service, as it has successfully done with other applications of the µParaflo® technology such as miRNA profiling, small RNA discovery, kinase profiling and epitope mapping with peptide arrays, and others.

“We find that researchers would prefer to spend their valuable time focusing on their research, not figuring out how to make successful use of someone else’s new technology”, says Chris Hebel, Director of Business Development. “We offer a comprehensive solution: customers tell us their experiment goals, send us their samples and we provide the material ready for sequencing. There is no reason they need to become target selection experts to keep their research moving forward. We have already developed methods to design optimized hybridization probes and suitable experimental procedures and conditions for different sample types, such as miRNA, small RNA, or genomic DNA samples, on different sequencing platforms. We can even perform the high-throughput sequencing and deliver the results, as not all labs have access to next-generation sequencers yet.”

More information about LC Sciences’ Targeted Sequencing Sample Enrichment Service and the µParaflo® technology is available at:http://www.lcsciences.com/targeted_sequencing.html.

About LC Sciences – LC Sciences is a genomics and proteomics products company offering a comprehensive line of DNA, RNA, and peptide microarrays for nucleic acid/protein profiling and functional analysis, biomarker-discovery, novel drug screening, and the custom development of miniaturized assay devices for diagnostics and biosensing applications. Based on the µParaflo® microfluidics technology, LC Sciences’ innovative products and services offer significant flexibility and customization capability for rapidly evolving, diverse customer needs. In an era of rapid technological advancement, LC Sciences offers service products which enable efficient one-stop solution for assays of DNA, RNA, protein, enzymes, antibodies, or small molecules. LC Sciences also provides unique synthetic DNA and RNA products such as OligoMix®, generated using their microfluidic biochip synthesizer. These innovative products drive synthetic biology, systems biology and sequencing applications by reducing the cost and increasing the speed of highly multiplexing large-scale nucleic acid and protein engineering experiments.

More information about LC Sciences is available at www.lcsciences.com.

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Consistent Development Of Stable-High Expressing Mammalian Cell Lines In Four Months Using Gpex®

Dr. Greg Bleck, the senior director of cell line engineering at Catalent Pharma Solutions, will present later this month at the 12th Annual Pep Talk 2009 Protein Expression Conference to be held in San Diego, C.A., January 12-14, 2009. The conference offers a strong scientific program with more than 120 presentations and poster sessions reviewing the latest research and leading edge technologies in the field.

Dr. Bleck’s presentation is titled “Consistent Development of Stable-High Expressing Mammalian Cell Lines in Four Months Using GPEx®.” Catalent’s proprietary GPEx® method of cell line engineering generates high-expressing, genetically stable cells for all mammalian cell types. Antibiotic selection is not needed as part of the procedure; so multiple gene constructs can be added individually, at different gene ratios without any requirement for antibiotic resistance markers. This allows re-production of cellular pathways within these cell types as well as the ability to easily add protein processing enzymes to an already established cell line. Specific productivities of GPEx® antibody producing cell lines range from 30 -70 picograms/cell/day without upstream process development, while cell lines producing non-antibody proteins as expected have a much broader range of productivities, but if the protein has no secretion problems and does not inhibit cell growth, specific productivities similar to antibodies are obtained.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer health companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at more than 30 facilities worldwide and generates more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

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Dr. Greg Bleck Of Catalent Pharma Solutions, Will Present At The 2nd International Cell Engineering Conference

Dr. Greg Bleck, the senior director of cell line engineering at Catalent Pharma Solutions, will present this week at the 2nd International Cell Engineering Conference to be held in Santa Barbara, C.A., December 2-4, 2008. The conference will include presentations by leading pharmaceutical companies, small biotech organizations, academics, and key technology supply firms covering the latest advancements in cell line development. Special emphasis will be placed on the reliability and reproducibility of the more promising cell engineering techniques. The conference is produced by the Williamsburg BioProcessing Foundation.

Dr. Bleck’s presentation is titled “Generation of Stable-High Expressing Mammalian Cell Lines in Four Months without Antibiotic Selection or Gene Amplification Using GPEx®.” Catalent’s proprietary GPEx® technique for cell line engineering allows high-expressing, genetically stable cells for any mammalian cell type to be produced without antibiotic selection or gene amplification. The lack of selection and amplification allows these master cell bank candidate cell lines to be made in four months, and permits research and development scientists to contemplate new paths for improved expression of their proteins. The candidate cell lines range in specific productivities from 30-95 picograms/cell/day for antibodies and have reached as high as 50-70 picograms/cell/day for some recombinant protein producing cell lines. Cell lines producing over 150 different antibodies and 40 different recombinant proteins have been developed with GPEx®. Data showing the consistency and speed of the technology, as well as the stability and productivity of the cell lines will be presented.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer health companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at more than 30 facilities worldwide and generates more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

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LC Sciences announced the availability of probe content miRBase 10.0 for their microRNA (miRNA) microarray customers

Taking advantage of its flexible µParaflo™ Chip Technology, Houston based LC Sciences today announced immediate availability of probe content miRBase 10.0 for their microRNA (miRNA) microarray customers. This announcement comes less than a week after Sanger Institute’s update of their sequence database for known miRNAs (miRBase) 1 to version 10.0 (http://microrna.sanger.ac.uk/sequences). As the jump in

version numbers from 9.2 to 10.0 suggests, this update marks a major milestone and features significant changes: 489 new hairpin sequences and 971 novel mature miR and miR* experimentally verified products have been added.

These numbers represent an increase of unique miRNA sequences by 42%. “This exciting increase in data means that researchers using pre-spotted glass arrays with probe content based on versions as recent as 9.1 are missing 49% of mouse, and more than 50% of human sequences, just to give two examples. The other important point is that these sequences are experimentally verified and publicly available data. Unlike with proprietary probe content the researcher has full access and control over the results.” said Chris Hebel, Director of Business Development at LC Sciences.

The importance of this update is emphasized by another aspect of the release: many human, mouse and rat mature miRNAs were renamed and the sequence boundaries changed to reflect the predominant forms identified in recent large-scale cloning studies. The public miRBase sequence database serves as the primary probe content for many commercially available miRNA profiling microarrays. Detection of miRNAs using a microarray offers the opportunity for genome-wide miRNA expression profiling by examining all known miRNA transcripts in a single experiment. However, the continued updating of the database can be problematic for researchers using pre-spotted glass slide arrays as the probe content of the arrays immediately goes out of date whenever a new miRBase version is released. Especially, in a rapidly evolving field as miRNA research it is important to scientists to have the most complete picture of miRNAs expressed in their experimental samples.

LC Sciences miRNA microarrays make use of a microfluidics on-chip synthesis platform, termed µParaFlo™, versus a traditional spotted array based on pre-synthesized oligonucleotides. This on-chip synthesis platform solves the issue of out of date microarrays because made-to-order microarrays can be produced, delivering the most up-to-date research tools to researchers.

In addition to providing much more uniform and reproducible features than a spotted array, on-chip synthesis permits the total customization of content on each individual microarray opening up additional applications such as the discovery of new miRNAs and other small non-coding RNAs.

About microRNA (miRNA)
miRNAs are small non-protein-coding RNA molecules that function as negative regulators of gene expression by base pairing with specific mRNAs. This either inhibits translation or promotes mRNA degradation. About miRBase – The miRBase sequence database is a comprehensive database of miRNA sequence data, annotation, and predicted gene targets and is the primary public repository for these data. Release 10.0 of the database contains 5071 entries representing hairpin precursor miRNAs, expressing 4922 maturemiRNA products, in primates, rodents, birds, fish, worms, flies, plants and viruses (miRBase release summary). miRBase also provides a gene-naming service for assigning official miRNA names to novel miRNAs before they are published. It is freely available to all at http://microrna.sanger.ac.uk/.

About LC Sciences
LC Sciences offers specialty microarray services for nucleic acid/protein profiling and functional analysis, biomarker-discovery, and novel drug screening. Our array service products are based on Atactic Technologies’ µParaflo™ platform technologies that encompass advanced digital chemical synthesis, pico-liter scale biochemical assays, and microfluidic reaction devices containing high density individual 3D chambers.

 

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CodeLink business assets have been transferred under the agreement between Applied Microarrays and GE Healthcare

Applied Microarrays, Inc announced today the completion of Applied Microarrays’ purchase of certain assets of GE Healthcare’s CodeLink™ Gene Expression Bioarray System. Under the terms of the agreement, Applied Microarrays, Inc acquires certain equipment, inventory, licenses and assigned contracts associated with the CodeLink platform. Financial terms were not disclosed.

The transaction enables Applied Microarrays to provide CodeLink users with continued and uninterrupted access to the industry-leading gene expression platform as Applied Microarrays, Inc continues to develop, market, distribute, sell, and support the existing CodeLink catalogue of whole genome expression arrays, Codelink custom arrays and Codelink inside arrays.

Alastair Malcolm, president and chief executive officer of Applied Microarrays, said, “We’re pleased to now have a unique opportunity to launch our company with a full range of microarray design, development, and manufacturing competencies and at the same time ensure a seamless transition for customers.

Eric Roman, General Manager Genomic Sciences, GE Healthcare, said, “There has been strong demand from CodeLink customers to keep these products in the marketplace. We’re delighted to have found a way for our customers to continue working with one of the best gene expression platforms available.”

“The CodeLink platform is customer-proven over several years, notably demonstrating world-class technical performance in the FDA-led MicroArray Quality Control project,” Malcolm said. Applied Microarrays is immediately opening the CodeLink platform to the microarray community for new applications development, offering customers the opportunity to place their unique custom array content on to a robust, proven platform which can be manufactured in high volume.

Applied Microarrays aims to be a leading contract manufacturer of microarrays, of any type, for any customer, with no limitations on substrate material or spotted fluid. “We are fortunate in this regard to have acquired an intact high-capacity microarray spotting facility, employing Six Sigma techniques since its inception to produce leadership quality products,” Malcolm said.

About Applied Microarrays, Inc.
Applied Microarrays is a new company headquartered in Tempe, Arizona. Using the microarray assets acquired from GE, and staffed with experts who developed the CodeLink platform and manufacturing capabilities, the company will specialize in contract development and manufacturing of custom microarrays of all types. The company will additionally continue to offer the CodeLink family of gene expression arrays, and customer-specified subsets of that content on multi-array formats. Our vision is to be the microarray partner of choice for focused “omics” research, and the leading high-volume contract manufacturer for research and diagnostic arrays.

About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. GE Healthcare’s expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare’s broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. GE Healthcare’s vision for the future is to enable a new “early health” model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

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