Bio Products Laboratory Ltd

Hertfordshire, United Kingdom

Bio Products Laboratory Ltd

Hertfordshire, United Kingdom
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"Due to the harmful long-term effects of repeated bleeding episodes, a prophylactic regimen of a single factor concentrate for the prevention of bleeds is a recognized best practice in treating bleeding disorders," said Dr. Michael Gattens, Consultant Paediatric Haematologist, Cambridge University Hospitals, UK and one of the investigators in the TEN02 clinical trial. "For the first time, we have data providing physicians with important evidence of the efficacy and safety of Coagadex as a prophylactic regimen for the reduction and prevention of bleeding episodes, as well as potential guidance on dosing for children with hereditary factor X deficiency." The primary endpoint of the study was the prophylactic efficacy of Coagadex, which was rated as "excellent" by the investigators for all subjects in the per-protocol population. A dosing regimen of 40–50 IU/kg twice weekly was recommended in the study; dose and frequency were adjusted over the initial six weeks to maintain factor X concentration levels ≥5 IU/dL (with peak levels ≤120 IU/dL). Data from the study showed that Coagadex was effective in preventing bleeding episodes in subjects <12 years old with moderate to severe factor X deficiency. Consistent with previous findings in subjects ≥12 years old, Coagadex was well tolerated and safe among subjects <12 years old. These new data expand on the established efficacy of Coagadex, which was approved in October 2015 for the treatment of adults and children (aged 12 years and over) with hereditary factor X deficiency for on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in patients with mild hereditary factor X deficiency. Coagadex is the first and only FDA-approved product to treat hereditary factor X deficiency and is the only specific factor X concentrate available in the U.S. Hereditary factor X deficiency is a rare bleeding disorder that affects approximately 300-600 patients in the U.S. Affected individuals often have inadequate amounts of circulating factor X, an important component of the coagulation system. Factor X deficient patients are at increased risk of bleeding and need to be managed similarly to hemophilia patients. In clinical studies, the most common adverse reactions (frequency ≥5% of subjects) with Coagadex were infusion site erythema, infusion site pain, fatigue and back pain. Please see the Important Safety Information below and www.coagadex.com for full prescribing information. The poster from the TEN02 study was published in a special July issue of Research and Practice in Thrombosis and Haemostasis and can also be found on the 2017 International Society on Thrombosis and Haemostasis Congress website. TEN02 (ClinicalTrials.gov NCT01721681) was an open-label, multicenter, nonrandomized, phase 3, prospective study conducted in children <12 years with a diagnosis of moderate or severe congenital factor X deficiency (basal plasma factor X activity <5 IU/dL at diagnosis) and either a history of severe bleeding or an F10 gene mutation causing a documented severe bleeding type. In the study, subjects received 50 IU/kg of Coagadex at visit 1 (baseline), followed 72 hours later by a second dose (visit 2); at the investigator's discretion, visit 2 may have been conducted 48 hours after the first dose for subjects aged 0–5 years. Following visit 2, subjects returned to the study site for 3 additional visits (after 9–28, 29–42, and 50 treatment days/26 weeks; visits 3–5), during which time blood samples were collected to assess FX:C trough levels and vital signs and adverse events (AEs) were checked. A final bolus dose of 50 IU/kg was administered during visit 5 to assess postdose incremental recovery. Coagadex, a plasma-derived blood coagulation factor X concentrate, is indicated in adults and children (aged 12 years and above) with hereditary Factor X deficiency for: Perioperative management of bleeding in major surgery in patients with moderate and severe hereditary Factor X deficiency has not been studied. Coagadex is contraindicated in patients with known hypersensitivity to any of the components of the product. Allergic type hypersensitivity reactions, including anaphylaxis, are possible with Coagadex. If symptoms occur, patients should discontinue use of the product immediately and contact their physician. The formation of neutralizing antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency. Carefully monitor patients taking Coagadex for the development of inhibitors by appropriate clinical observations and laboratory tests. Coagadex is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. No cases of transmission of viral diseases, vCJD or CJD, have been associated with the use of Coagadex. In clinical studies, the most common adverse reactions (frequency ≥5% of subjects) with Coagadex were infusion site erythema, infusion site pain, fatigue and back pain. For complete Prescribing Information for Coagadex please see www.coagadex.com. Bio Products laboratory, Limited (BPL) is a leading manufacturer of plasma-derived protein therapies with global headquarters in Elstree, England, US headquarters in Durham, NC, and a presence in more than 45 countries worldwide.  The company has over 60 years of experience developing and manufacturing plasma-derived therapies since being established as part of the Lister Institute in 1950, and currently markets a wide range of products, including coagulation factors, human immunoglobulins, and albumin.  BPL is committed to continued investment in research and development to maintain its key position as a reliable supplier of high-quality products to patients and healthcare providers worldwide.


— Pipeline report on Sickle Cell Disease - Pipeline Review, H1 2017, provides comprehensive information on the therapeutics under development for Sickle Cell Disease (Hematological Disorders). The complete is analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. Browse the 54 Tables and 11 Figures, 36 Company Profiles, Spread across 191 Pages Report Available at http://www.reportsnreports.com/reports/992906-sickle-cell-disease-pipeline-review-h1-2017.html . Sickle Cell Disease - Companies Involved in Therapeutics Development - Acceleron Pharma Inc, Addex Therapeutics Ltd, Addmedica SAS, Advinus Therapeutics Ltd, Alnylam Pharmaceuticals Inc, Angiocrine Bioscience Inc, ArQule Inc, Bio Products Laboratory Ltd, Bioverativ Inc, bluebird bio Inc, Bristol-Myers Squibb Company, Calimmune Inc, CRISPR Therapeutics, CSL Ltd 35,Editas Medicine Inc, Errant Gene Therapeutics LLC, Gamida Cell Ltd, Genethon SA, Gilead Sciences Inc, Global Blood Therapeutics Inc, Incyte Corp, Johnson & Johnson, La Jolla Pharmaceutical Company, MaxCyte Inc, Merck & Co Inc, Modus Therapeutics Holding AB, Morphogenesis Inc, NKT Therapeutics Inc, Novartis AG, Orphagen Pharmaceuticals Inc, Pfizer Inc, Prolong Pharmaceuticals LLC, Protagonist Therapeutics Inc, ReveraGen BioPharma Inc, Sancilio & Company Inc, Sangamo Therapeutics Inc. Sickle cell anemia is a genetic (inherited) blood disorder in which red blood cells, which carry oxygen around the body, develop abnormally. Signs and symptoms include anemia, delayed growth, vision problems, pain and frequent infections. Treatment includes antibiotics, pain relievers, blood transfusion and stem cell transplant. The Sickle Cell Disease (Hematological Disorders) pipeline guide also reviews of key players involved in therapeutic development for Sickle Cell Disease and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Phase III, Phase II, Phase I, Preclinical, Discovery and Unknown stages are 1, 5, 5, 9, 27, 6 and 1 respectively. Similarly, the Universities portfolio in Phase II, Phase I, Preclinical and Discovery stages comprises 1, 1, 5 and 2 molecules, respectively. Place Order to This Report at http://www.reportsnreports.com/purchase.aspx?name=992906 Sickle Cell Disease (Hematological Disorders) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Scope • The pipeline guide provides a snapshot of the global therapeutic landscape of Sickle Cell Disease (Hematological Disorders). • The pipeline guide reviews pipeline therapeutics for Sickle Cell Disease (Hematological Disorders) by companies and universities/research institutes based on information derived from company and industry-specific sources. • The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages. • The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities. • The pipeline guide reviews key companies involved in Sickle Cell Disease (Hematological Disorders) therapeutics and enlists all their major and minor projects. • The pipeline guide evaluates Sickle Cell Disease (Hematological Disorders) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. • The pipeline guide encapsulates all the dormant and discontinued pipeline projects. • The pipeline guide reviews latest news related to pipeline therapeutics for Sickle Cell Disease (Hematological Disorders) About Us: ReportsnReports.com is your single source for all market research needs. Our database includes 500,000+ market research reports from over 95 leading global publishers & in-depth market research studies of over 5000 micro markets. With comprehensive information about the publishers and the industries for which they publish market research reports, we help you in your purchase decision by mapping your information needs with our huge collection of reports. For more information, please visit http://www.reportsnreports.com/reports/992906-sickle-cell-disease-pipeline-review-h1-2017.html


Sandle T.,Bio Products Laboratory Ltd
American Pharmaceutical Review | Year: 2017

This article has introduced some of the important elements that make up a contamination control strategy for aseptically filled products. There are, of course, other elements such as cleaning validation and the environmental monitoring strategy? the purpose here was to focus on the core parts of the contamination control strategy and to highlight areas that are sometimes overlooked. Some of the topics selected are being strengthened by advances in technology and it is with further technological advances that the industry must continue to lend its support. Any overreliance upon microbiological tests, which have not kept pace with the revelations about the diversity of nonculturable but active microorganisms, should be avoided for these do not provide sufficient assurance of product sterility. The key message of this article is to focus on strengthening control.


Sandle T.,Bio Products Laboratory Ltd
American Pharmaceutical Review | Year: 2016

This article has considered sanitization in pharmaceutical facilities and has sought to present best practices. The article has not so much centered on the science of disinfection, but rather to offer practical advice for those who need to use and select disinfectants and to put them into effective use. Ensuring that contamination is controlled in cleanrooms, on and in equipment, and in relation to personnel is an important step in maintaining microbial control of the production process and a focus on the fabric and structure in which pharmaceutical products are prepared is as important as bioburden reduction steps within the product itself.


Sandle T.,Bio Products Laboratory Ltd
American Pharmaceutical Review | Year: 2016

This short article has outlined some of the key considerations to be made when selecting between the different types of rapid methods that are available. The article did not set out to differentiate between different technologies (this itself is a rapidly developing field), but more to offer general advice to those tasked with making the selection.


Trademark
Bio Products Laboratory Ltd | Date: 2016-03-03

human albumin preparations used for the restoration of blood or body fluids, administered as an intravenous infusion for medical use.


Trademark
Bio Products Laboratory Ltd | Date: 2016-03-03

human albumin preparations used for the restoration of blood or body fluids, administered as an intravenous infusion for medical use.


Trademark
Bio Products Laboratory Ltd | Date: 2016-03-03

human albumin preparations used for the restoration of blood or body fluids, administered as an intravenous infusion for medical use.


Trademark
Bio Products Laboratory Ltd | Date: 2016-03-03

human albumin preparations used for the restoration of blood or body fluids, administered as an intravenous infusion for medical use.


Trademark
Bio Products Laboratory Ltd | Date: 2016-03-03

human albumin preparations used for the restoration of blood or body fluids, administered as an intravenous infusion for medical use.

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