Thermo Scientific Cell Culture and Bioprocessing The Thermo Scientific HyClone product line in Logan, Utah helps to make the world healthier, cleaner and safer by producing leading cell culture products and bioprocessing systems for life-science research and...
Meridian Life Science, Inc. From concept to commercialization, Meridian Life Science integrates biological materials into a wide array of products designed to diagnose and treat disease with accuracy and efficacy.
RSV Memphis 37
RSV Memphis 37 consists of an RSV high titer stock produced in characterized Vero cells infected with an RSV virus strain isolated from an original...
Sanofi-Pasteur Sanofi Pasteur, the vaccines division of sanofi-aventis Group, is the largest company in the world devoted entirely to human vaccines. The company's driving goal is to protect people from infectious diseases by creating...
Vaccination Coverage
With stable and high vaccination coverage, disease declines and can even be eliminated. For example, reported measles cases in the European Region fell from...
Vaccines Save Lives
There is a vast range of vaccines available to protect against more than 26 infectious diseases – and there are new vaccines on the horizon with the...
Vaccines Save Money
Vaccines certainly prevent death and suffering, but they also save money. Vaccination is one of the most cost-effective health-care investments available.
VacZine Analytics Group VacZine Analytics is an established strategic research consultancy based in the United Kingdom.The company provides provide high-quality disease and commercial analysis to those working within or in collaboration with the...
ExpertREACT
The aim of ExpectREACT is to respond to events within the vaccines sector and communicate to clients their potential impact and significance. It will also...
MarketVIEW
MarketVIEW is a vaccine forecast model. It is a comprehensive spreadsheet designed to give the most essential commercial readouts.
VaccineSTATS
VaccineSTATS is designed to be a first "port-of-call" for rapid access to vaccine market information and statistics.
Case-building data and facts are...
Bridge Laboratories Bridge is a preclinical CRO that provides US-level regulatory compliant toxicology services. Headquartered in Gaithersburg, Maryland, with lab facilities in the US and China; Bridge specializes in vaccines, DART,...
Vaccines
Brige Laboratories experienced in-life and post-life staff works to determine safety, immune response and biodistribution over a variety of species, routes...
Genvec GenVec, Inc. (NASDAQ: GNVC) is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Each of our gene-based therapeutic product candidates uses a common patent-protected technology...
Antigenics, Inc. Antigenics' mission is to enhance and extend lives through the development of superior health care products for a wide range of cancers, infectious diseases and autoimmune disorders.
Lead Products in Development at...
Although the regulation of biologics, drugs and devices shares many of the same basic principles and procedures, important and unique regulatory considerations apply to each of these products. Some of these considerations involve product type–specific marketing applications, manufacturing regulations and adverse event reporting procedures, to name a few. This chapter focuses primarily on the ...
Boosting Patient Recruitment in Oncology Trials A CEE of Opportunity
Boosting Patient Recruitment in Oncology Trials A CEE of Opportunity
Averion International Corp. is an international CRO with extensive experience in designing and conducting complex multi-center international oncology trials. Over the past 25 years, we have conducted over 200 oncology studies in 43 countries ranging from ...
Conducting comprehensive metabolism studies has long been an essential component of a preclinical drug development program. However, numerous factors — including the increased development of protein-derived drugs and the expanded interest in the role of metabolites in safety assessment — are having a significant impact on the regulatory mandates, scope of studies and methodologies employed. In ...
The approval by the Food and Drug Administration (FDA) of the first inhaled insulin combination product for treatment of diabetes represents a milestone in drug delivery. Exubera is an inhaled powder form of recombinant human insulin (rDNA) used in the treatment of adult patients with type 1 and type 2 diabetes and is the first new delivery option introduced since the discovery of insulin in the ...
In March 2006, six normal healthy volunteers par- ticipating in a clinical study in the UK were given an intravenous (IV) dose of an experimental immunother- apeutic as a part of an ascending single dose safety and tol- erability study. Within a few hours of drug administration, all subjects exhibited severe reactions which progressed to multiple organ failure. As a result of the incident, ...
A clinical grade recombinant human Parvovirus B19 (HPVB19) vaccine has been developed to treat transient aplastic crisis (TAC) in patients with sickle cell anemia. The vaccine consists of two viral proteins (VP1 and VP2) in separate baculovirus vectors that are co-infected at the correct MOIs into Spodoptera frugiperda (Sf9) cells and that, upon expression, self assemble into immunogenic ...
Historically, vaccines are medicines that deliver or generate antigens that induce specic, active, and protective immunity against infectious diseases. Antigens stimulate the immune system to activate cells and organs that induce active immunity, characterized by production of antibodies (humoral immunity) and/or cytotoxic T-cells (cell mediated immunity). Vaccines “train” the body’s immune ...
Development and manufacturing of recombinant-protein–based vaccines has in the past few years become very similar to that of other well-documented and well-characterized biological drugs. For investigational vaccines, chemistry, manufacturing, and controls (CMC) information is critical for a successful regulatory filing. The process development and CGMP manufacturing of a recombinant protein drug ...
Outsourcing is one of the commonly used approaches by pharmaceutical companies. Increasingly, pharma and biotech firms are searching for new drivers of revenue and profit growth. There are a number of trends and forces within the pharmaceutical industry that are causing companies to rethink their approaches to growth and cost management.
Biotech was “born” in the 1970s. Since that time innovation by biotech pioneers has brought more than 200 medicines and vaccines to fruition for difficult-to-treat indications including oncology, HIV/ AIDs, diabetes, and immune disorders.
Biotech is poised to capitalize on the current challenges confronting Big Pharma: looming patent expirations on blockbuster medicines and a dearth of new ...
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