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Copenhagen, Denmark

Holch A.,Technical University of Denmark | Holch A.,CMC Biologics | Webb K.,Allegheny College | Lukjancenko O.,Technical University of Denmark | And 3 more authors.
Applied and Environmental Microbiology | Year: 2013

Listeria monocytogenes is a food-borne human-pathogenic bacterium that can cause infections with a high mortality rate. It has a remarkable ability to persist in food processing facilities. Here we report the genome sequences for two L. monocytogenes strains (N53-1 and La111) that were isolated 6 years apart from two different Danish fish processers. Both strains are of serotype 1/2a and belong to a highly persistent DNA subtype (random amplified polymorphic DNA {left open bracket}RAPD{right open bracket} type 9). We demonstrate using in silico analyses that both strains belong to the multilocus sequence typing (MLST) type ST121 that has been isolated as a persistent subtype in several European countries. The purpose of this study was to use genome analyses to identify genes or proteins that could contribute to persistence. In a genome comparison, the two persistent strains were extremely similar and collectively differed from the reference lineage II strain, EGD-e. Also, they differed markedly from a lineage I strain (F2365). On the proteome level, the two strains were almost identical, with a predicted protein homology of 99.94%, differing at only 2 proteins. No single-nucleotide polymorphism (SNP) differences were seen between the two strains; in contrast, N53-1 and La111 differed from the EGD-e reference strain by 3,942 and 3,471 SNPs, respectively. We included a persistent L. monocytogenes strain from the United States (F6854) in our comparisons. Compared to nonpersistent strains, all three persistent strains were distinguished by two genome deletions: one, of 2,472 bp, typically contains the gene for inlF, and the other, of 3,017 bp, includes three genes potentially related to bacteriocin production and transport (lmo2774, lmo2775, and the 3′-terminal part of lmo2776). Further studies of highly persistent strains are required to determine if the absence of these genes promotes persistence. While the genome comparison did not point to a clear physiological explanation of the persistent phenotype, the remarkable similarity between the two strains indicates that subtypes with specific traits are selected for in the food processing environment and that particular genetic and physiological factors are responsible for the persistent phenotype. © 2013, American Society for Microbiology. Source


Patent
CMC Biologics | Date: 2014-03-11

The invention provides expression vectors and host cells for high-level expression of recombinant proteins. The expression vectors comprise Chinese hamster ovary elongation factor 1- (CHEF1) transcriptional regulatory DNA elements and a cytomegalovirus (CMV) promoter and/or a human adenovirus tripartite leader (AdTPL) sequence. The invention achieves increased protein expression and better productivity of host cells compared to previously described expression systems.


Patent
CMC Biologics | Date: 2015-11-25

Materials and methods are provided which allowed for increased expression of a transfected gene of interest in a recombinant host cell.


SEATTLE and BERKELEY, California and COPENHAGEN, Denmark, March 19, 2015 /PRNewswire/ -- CMC Biologics, Inc., a leading global contract manufacturing organization known for technical excellence and customer satisfaction in biopharmaceutical development and commercial manufacture of protein-based therapeutics, was recognized for the third consecutive year for quality and reliability by Life Science Leader at an awards ceremony at DCAT Week '15 in New York. "The CMC Biologics' team is honored to receive this prestigious award as recognition from our customers and the industry as a whole," said Gustavo Mahler, PhD, Global Chief Operations Officer. "Our customers count on us to deliver comprehensive process development and manufacturing solutions essential for their clinical and commercial success; and this award underscores our proven track-record in technical excellence and customer satisfaction across every aspect of our business." Bringing new pharmaceutical products to market is time consuming and costly, thereby having reliable and effective contract organizations to work with helps streamline that process. The Life Science Leader CMO Leadership awards are designed to honor top performers based on survey responses from thousands of industry executives, conducted by Nice Insight, and to better serve biopharmaceutical executives in their CMO selection process. This data will help companies focus on potential CMO partners who can manage their projects and are considered most reputable in the industry. About CMC Biologics CMC Biologics is leading the industry among CMO's in reliability, technical excellence, and quality – Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scaleup and cGMP manufacture of protein-­ based therapeutics for pre­clinical, clinical trials and commercial production. The Company's wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-­batch and perfusion production processes. More detailed information can be found at www.cmcbiologics.com.


-- Bioreactor 6Pack™ facility design provides innovative, flexible solutions to customers for phase III and commercial production SEATTLE and BERKELEY, California and COPENHAGEN, Denmark, May 20, 2015 /PRNewswire/ -- CMC Biologics, Inc., a global leader in clinical and commercial manufacturing of therapeutic proteins, announced today that as part of its global manufacturing capacity expansion strategy, it will add approximately 14,000 liters of additional manufacturing capacity to its Copenhagen, Denmark facility. Customers will soon have greater flexibility in the manufacture of large-scale, late-stage and commercial products through CMC Biologics' innovative single-use Bioreactor 6PackTM facility design.  The Bioreactor 6Pack™ configuration consists of six 2000L production bioreactors in one manufacturing line, allowing for flexible production with scales from 2,000L to 14,000L in a single production suite. The bioreactors can be run singly or in groups, simultaneously, sequentially or in staggered fashion to achieve production needs. The Copenhagen installation, scheduled for initial GMP production in November 2015, will consist of a Bioreactor 3Pack™ configuration consisting of a seed train and three 2,000L single-use production bioreactors. Three additional 2,000L bioreactors will be added at a later date to complete the Bioreactor 6Pack™ line.   We have completed construction of the Bioreactor 6Pack™ in the Seattle facility and will conduct the first GMP run mid-2015, and will be in full production for a commercial launch later this year. "CMC Biologics is significantly investing in innovative facility design to address our customers' need for production flexibility, to meet aggressive regulatory and production timelines and to speed their products to market," said Gustavo Mahler, PhD, Global Chief Operations Officer of CMC Biologics.  "We are changing the way CMOs operate and our novel Bioreactor 6PackTM facility design is one more step in leading the market in technical excellence." About CMC Biologics CMC Biologics is leading the industry among CMOs in reliability, technical excellence, and quality — Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production. The Company's wide range of integrated services includes cell line development, bioprocess development, formulation development, and comprehensive analytical testing. Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. More detailed information can be found at www.cmcbiologics.com.

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