News Article | May 11, 2017
ROCKVILLE, Md.--(BUSINESS WIRE)--ABL, Inc. (ABL), a leading contract research, development and biomanufacturing organization to the biopharmaceutical industry worldwide, is proud to announce the successful expansion of its aseptic fill/finish operations at its Rockville, MD GMP biomanufacturing facility with the installation of a new, fully automated vial filling system. ABL’s new filling line was specifically selected by ABL to meet the needs of its clients developing innovative biologics, namely vaccines, gene therapies, oncolytic live virus-based therapies, monoclonal antibodies and recombinant proteins. The fill line can accommodate lot sizes from 100 to 5,000+ vials, with minimal product loss. The system utilizes a disposable product contact path to limit cross contamination and is contained in a RABS (Restricted Access Barrier System) to increase sterility assurance level (SAL) and prevent the chance of random contamination by operator intervention. Ms. Beth Tebeau, Vice President of Manufacturing, stated, “The addition of ABL’s new fully automated aseptic fill and finish line for high value biologics, including gene therapies, such as AAV, and live virus vaccines, takes ABL to the next level in terms of serving our clients’ and the market’s growing needs.” In addition to its Rockville operations, ABL maintains an isolator-based fill/finish line in Strasbourg, France capable of filling live virus products at 10,000 vials per lot. Reservations for new projects at both sites are currently being scheduled for the 3rd and 4th quarters of 2017. ABL is committed to providing the best solutions and technologies to meet the challenging and ever evolving needs of its clients. To this extent ABL has continued to expand its CMO operations, capabilities and capacity and has invested millions of dollars in the last two years, acquiring a GMP biomanufacturing facility in Strasbourg, France, adding additional upstream and downstream process capacity in Rockville, installing and qualifying the new fill line in Rockville and is currently expanding the Strasbourg GMP facility with the addition of new biomanufacturing suites and single use bioreactors. This commitment to providing the best services to its clients is what has led to ABL becoming recognized as one the leading biologics CMOs globally. In 2017, ABL has already been a finalist for Best Contract Manufacturing Organization (CMO) and Life Sciences Company of the Year awards. ABL, Inc. is a global biomedical contract research and biomanufacturing organization dedicated to advancing therapeutics, vaccines and other biologic products. ABL maintains GMP facilities meeting U.S. and European regulatory standards, providing process and assay development, cGMP manufacturing of bulk drug substance, cGMP aseptic fill and finish of drug product, and QC bioanalytical testing. Our U.S. and European immunobiology laboratories support clients’ preclinical and clinical sample processing and testing needs. ABL is a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally. For more information visit www.ablinc.com or email us. ABL Europe is a wholly owned subsidiary of ABL and encompasses a GMP biomanufacturing facility near Strasbourg, France. In addition to ABL’s GMP contract biomanufacturing facility in Rockville, ABL Europe supports clients’ diverse and growing drug substance and fill/finish needs. The Strasbourg site is capable of filling up to 10,000 vials per batch on its isolator based-line for preclinical, Phase I-III clinical trials and can produce commercial product.
News Article | June 29, 2017
"Master scheduling is an increasingly complex challenge that our principals grapple with as they attempt to balance the implementation of new national standards and the need to develop high-quality learning environments for all students," said Cheryl Hibbeln, Executive Director of Secondary Schools, San Diego Unified School District. "Master scheduling is the sort of real-world challenge that technology is perfectly suited to address, facilitating greater input from staff and bringing transparency to an important equity lever for school communities." Developed through a collaborative process that involved public school leaders from Tennessee, Texas, California, and Pennsylvania as design partners, the Abl platform enables administrators to transform an otherwise static process into a flexible approach that allows principals to test and evaluate scheduling scenarios. The platform was designed to address the most prevalent scheduling challenges for school leaders and make it easy to design and manage the daily life of a school. Abl maps to school leaders' existing planning processes to minimize training requirements, and works alongside a school's SIS to save administrators time. "The master schedule is, in many ways, the blueprint of a school – but a Rubik's Cube of programs, people, and events can make the scheduling process overwhelming and time-consuming for school leaders," said Abl Founder and CEO Adam Pisoni, who previously served as CTO and Co-Founder of Yammer. "We spent over a year learning about this challenge for school leaders – and then developing a solution that digitizes their workflow and gives unprecedented visibility into student course needs and resource allocation throughout the school day." According to the most recent MetLife survey of school leaders, three-quarters of principals in American schools believe the job of school leadership has become too complex. Dr. Timothy Wagner, Associate Principal for Program Planning & Innovation at Upper St. Clair High School in Pennsylvania, put it this way: "As the summer begins and we wrap up the master scheduling process, our team is committed to ensuring that we begin the next school year without a hitch. The team at Abl understands how difficult this work can be, and has developed an intuitive platform that allows us to easily evaluate master scheduling options to best support student course needs, avoid scheduling conflicts, and create more time for teacher planning." About Abl Developed through a collaborative process with school leaders, Abl is on a mission to transform master scheduling into a smart, collaborative process that enables school leaders to quickly visualize tradeoffs and meet the needs of every student and teacher. Our dynamic school scheduling platform makes it easy to design and manage the daily life of a school through a simple, cloud-based system that eliminates the spreadsheets, magnet boards, and calendaring tools most schools use today. For more information, visit www.ablschools.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/impact-investors-back-technology-to-support-principals-with-complex-challenge-of-master-scheduling-300481861.html
News Article | July 18, 2017
Developed in collaboration with secondary school leaders from Massachusetts, California, Pennsylvania, Tennessee, Rhode Island, and Texas, Abl's dynamic school scheduling platform makes it easier for principals to design and manage the daily life of a school, eliminating the need for spreadsheets, magnet boards, and stacks of paper. Because Master Scheduler's cloud-based app works alongside a school's existing student information system, the platform enables school leaders to quickly visualize tradeoffs, design, and refine the master schedule. "School leaders have been asking for tools like this for decades," said Lee Fleming, principal of San Diego's Bonsall High School, an Abl design partner. "Throughout our collaboration, Abl's design team focused on the real-world challenges we face to ensure that its software reflects the workflows and practices utilized by school principals. Their dynamic approach allows us to understand the impact of scheduling decisions in real time— and make adjustments that create space for teacher planning, collaboration and personalized learning." Master Scheduler streamlines the entire scheduling process from course requests to course placements to student assignments so busy administrators can tackle the entire process in one place. The platform incorporates an intuitive, drag-and-drop scheduling board that allows school leaders to view and edit schedules by department, section, and teacher. Because Master Scheduler provides access to real-time alerts on course conflicts, teacher prep time, and other metrics, administrators are able to quickly evaluate and adjust schedules throughout the planning process. "Over a year of collaboration with schools nationwide, we've learned firsthand what a complex and frustrating process master scheduling can be for school leaders," said Abl Founder, Adam Pisoni. "We're taking an incremental approach to the rollout of Master Scheduler so that we can learn from the experiences of a diverse, cross section of school leaders—and incorporate their feedback and vision into the platform as we expand to additional schools and districts." Schools that receive access will get free setup, training, and support during the fall, so they have everything they need to start the master scheduling process in January. Access will be granted on a rolling basis to up to 150 participants for the 2017/18 school year. About Abl Developed through a collaborative process with school leaders, Abl is on a mission to transform master scheduling into a smart, collaborative process that enables school leaders to quickly visualize tradeoffs and meet the needs of every student and teacher. Our dynamic school scheduling platform makes it easy to design and manage the daily life of a school through a simple, cloud-based system that eliminates the spreadsheets, magnet boards, and calendaring tools most schools use today. For more information, visit www.ablschools.com.
News Article | July 19, 2017
ROCKVILLE, Md.--(BUSINESS WIRE)--ABL, Inc. (ABL), a global contract research and manufacturing service provider, announced today it has been awarded the recompetition of the contract for “Preclinical Development Support” (Contract # HHSN272201700010I) by the Division of AIDS (DAIDS) within the National Institute of Allergy and Infectious Disease (NIAID) of the National Institutes of Health (NIH). The contract will run for a total of seven years with a maximum funding level of $318 million. Under this contract, ABL will provide NIH with a comprehensive portfolio of services including product development planning, process and bioanalytical assay development, cGMP manufacturing, product safety and release testing, immunogenicity testing, and regulatory support for promising HIV vaccine and other biologics candidates. The principal goal of this contract is to accelerate promising HIV prophylactic modalities into the clinic. Although there have been large strides in HIV point of care diagnostics and therapeutics since the beginning of the HIV epidemic, the international spread of HIV continues at a rate of more than 14,000 new infections every day, and AIDS remains the fourth leading cause of death globally (WHO). Therefore, the need for an effective vaccine and other methods to inhibit the infection and spread of HIV remain critical. As the program incumbent, ABL’s scientists have been working towards the development of an effective HIV vaccine, serving as the collaborative bridge between the some of the field’s most innovative investigators and the clinic. Since being involved in some of the ground-breaking initial research on the discovery and characterization of the HIV virus, the product development approach has been refined by ABL’s highly integrated teams providing comprehensive product development planning and addressing new concepts in vaccine design. “We look forward to continuing our partnership with DAIDS on this contract developing and testing promising HIV vaccines,” said Dr. Thomas VanCott, ABL’s President and CEO and Principal Investigator on the contract. “We believe this Preclinical Development Support contract will play an important role in transitioning the next phase of innovative ideas from the bench to the clinic. The entire ABL team is involved in this contract, and we share NIAID’s continued and strong dedication to identify and develop an effective HIV vaccine in the coming years of this contract.” Maryland’s Montgomery County Executive Isiah Leggett contributed, “I congratulate ABL on winning the important support from the National Institute of Allergy and Infectious Disease. Much remains to be done in order to control, and eventually eradicate, the HIV virus. This is literally a matter of life and death and ABL is on the front lines of this critical battle.” ABL, Inc. is a global biomedical contract research and manufacturing organization dedicated to advancing therapeutics, vaccines and other biologic products. ABL has extensive experience working with diverse organizations including industry, government and academic entities. ABL maintains GMP facilities meeting U.S. and European regulatory standards, providing process and assay development, cGMP manufacturing of bulk drug substance, cGMP aseptic fill and finish of drug product, and QC bioanalytical testing. Our U.S. and European immunological and molecular laboratories support clients’ preclinical and GCLP clinical sample processing and testing needs. ABL is a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally. For more information visit www.ablinc.com or contact us.
Drees C.,Tel Aviv University |
Drees C.,Lüneburg University |
Brandmayr P.,University of Calabria |
Buse J.,Johannes Gutenberg University Mainz |
And 15 more authors.
ZooKeys | Year: 2011
We investigated the extent of poleward shifts in the distribution range of Agonum viridicupreum due to climate change in the western Palaearctic. Species' records were obtained from extensive literature sources as well as from collections, and consistent amateur entomologists' recordings. Within the general geographic range of the species, we analyzed in detail two parts of both, the northern and southern distribution range boundaries: (1 and 2) north-western Germany (leading or high-latitude edge), (3) Israel and (4) southern Italy (rear or low-latitude edge). Temporal changes in the occurrence data of the species indicated a northward shift of the leading edge of a minimum of 100 km within the last 50 to 100 years. In contrast, according to the data gathered, the rear edge has not changed during the last decades. Further studies are needed in order to fully understand the underlying mechanisms of the different behaviour of leading and rear range edges of A. viridicupreum in the current context of global change. Despite our incomplete understanding, chronosequences of the occurrence of the given species have the potential to optimize climate niche modelling to predict trends in the distribution range in the future. © Claudia Drees et al.
Harry I.,ABL |
Drees C.,Tel Aviv University |
Hofer H.,Natural History Museum Karlsruhe SMNK |
Assmann T.,Lüneburg University
ZooKeys | Year: 2011
While pitfall trapping is generally accepted as the standard method for sampling carabid beetles, this method has rarely been used in mountain ecosystems, mainly due to the high labour intensity it involves. As part of a research project in the German Alps, we investigated the phenologic appearance of adult carabid beetles in mountain ecosystems along with the consequences of possible reductions in sampling periods. Our results show that an early activity peak among carabids is predominant in mountain ecosystems. However, there are differences among species: the main group of species showed the highest activity directly after snow melt, a second group showed a delayed activity peak and a small third group had no clear peak at all. Based on this study, we recommend two fortnightly sampling periods as a minimum for a sampling programme: one immediately after snow melt, and a second sampling period after a pause of two weeks. © Ingmar Harry et al.
Sangster T.,Charles River Associates |
Maltas J.,BASi |
Struwe P.,Celerion |
Hillier J.,Gen-Probe |
And 27 more authors.
Bioanalysis | Year: 2012
The 5th Global CRO Council for Bioanalysis (GCC) meeting, held in Barcelona, Spain, in November 2011, provided a unique opportunity for CRO leaders to openly share opinions, perspectives and to agree on bioanalytical recommendations on incurred sample reproducibility in multi-analyte assays, regulation of quality assurance/bioanalytical consultants and regulatory requirements for GCP. © 2012 Future Science Ltd.
Lowes S.,Quintiles |
Boterman M.,ABL |
Doig M.,ABS Laboratories |
Breda M.,Accelera |
And 88 more authors.
Bioanalysis | Year: 2012
An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years. © 2012 Future Science Ltd.
Shytaj I.L.,Instituto Superiore Of Sanita |
Chirullo B.,Instituto Superiore Of Sanita |
Wagner W.,BIOQUAL Inc. |
Ferrari M.G.,ABL |
And 10 more authors.
Retrovirology | Year: 2013
Background: HIV infection persists despite antiretroviral treatment (ART) and is reignited as soon as therapies are suspended. This vicious cycle is fueled by the persistence of viral reservoirs that are invulnerable to standard ART protocols, and thus therapeutic agents able to target these reservoirs are needed. One such agent, auranofin, has recently been shown to decrease the memory T-cell reservoir in chronically SIVmac251-infected macaques. Moreover, auranofin could synergize with a fully suppressive ART protocol and induce a drug-free post-therapy containment of viremia.Results: We administered buthionine sulfoximine (BSO), an inhibitor of glutathione synthesis currently in clinical trials for cancer, in combination with auranofin to chronically SIVmac251-infected macaques under highly-intensified ART (H-iART). The ART/auranofin/BSO therapeutic protocol was followed, after therapy suspension, by a significant decrease of viral RNA and DNA in peripheral blood as compared to pre-therapy levels. Drug-free post-therapy control of the infection was achieved in animals with pre-therapy viral loads ranging from values comparable to average human set points to levels largely higher. This control was dependent on the presence CD8+ cells and associated with enhanced levels of cell-mediated immune responses.Conclusions: The level of post-therapy viral set point reduction achieved in this study is the largest reported so far in chronically SIVmac251-infected macaques and may represent a promising strategy to improve over the current " ART for life" plight. © 2013 Shytaj et al.; licensee BioMed Central Ltd.
PubMed | ABL
Type: | Journal: ZooKeys | Year: 2011
While pitfall trapping is generally accepted as the standard method for sampling carabid beetles, this method has rarely been used in mountain ecosystems, mainly due to the high labour intensity it involves. As part of a research project in the German Alps, we investigated the phenologic appearance of adult carabid beetles in mountain ecosystems along with the consequences of possible reductions in sampling periods. Our results show that an early activity peak among carabids is predominant in mountain ecosystems. However, there are differences among species: the main group of species showed the highest activity directly after snow melt, a second group showed a delayed activity peak and a small third group had no clear peak at all. Based on this study, we recommend two fortnightly sampling periods as a minimum for a sampling programme: one immediately after snow melt, and a second sampling period after a pause of two weeks.