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...
United States Biological USBiological is a long-established biotech manufacturer located near Boston, offering a wide range of biologicals, biochemicals and the largest selection of antibodies you will find anywhere. USBio offers over 100,000...
Formatech Inc Formatech, founded in 1993, provides contract services that deliver unique solutions to our clients’ product development and manufacturing challenges.The company's service offerings include: preformulation and formulation...
Biotest Laboratories Inc. Biotest Laboratories, Inc. was organized by Gregg A. Mosley in 1988 as a test laboratory for manufacturers of medical products.The cornerstone of Biotest Laboratories, Inc.'s relationships with our customers is to provide...
Therapex THERAPEX is a division of E-Z-EM Canada Inc., a Montreal subsidiary of E-Z-EM, Inc.Located in Montreal, Canada, THERAPEX is a provider of turnkey outsourced drug development and manufacturing services with over 35 years...
Applied Laboratories Inc. Established in 1984 as a regulatory consulting firm specializing in FDA submissions, Applied Laboratories, Inc. has evolved into a full-service contract manufacturer and packager. Applied Laboratories, Inc. is registered...
Testosterone, an endogenous hormone is the most important androgen secreted into the blood by the Leydig cells in the testes. In women, testosterone also is probably the prin- cipal androgen and is synthesized both in the corpus luteum and the adrenal cortex by simi- lar pathways [Snyder 2001]. Testosterone de- ficiency in men (hypogonadal) is always as- sociated with incomplete development of ...
The risk of virus contamination is a feature common to all biotechnology products produced from animal or human sources. Contamination can arise from a source cell line or from adventitious virus introduced during production. The approach to ensuring viral safety includes several complementary approaches, which are laid out in guidelines from the FDA, EMEA and ICH (references 1-4). These ...
Immunohistochemistry is widely used in basic research to understand the distribution and localization of biomarkers and differentially expressed proteins in different parts of a biological tissue. IHC staining is also widely used in the diagnosis of abnormal cells such as those found in cancerous tumors. Visualizing an antibody-antigen interaction can be accomplished in a number of ways. In the ...
For companies performing photostability testing in accordance with ICH guideline Q1B, CARON's 6540 series chambers overcome the challenges of lamp selection, light control, and other chamber design issues. By integrating technical requirements with practical solutions, CARON's Phoot stability Chambers enhance the testing process to ensure product quality and regulatory compliance.
ICH Q1B ...
Photostability testing is required for new drug substances and drug products in order to ensure that no significant losses of the active ingredients occur. It also is used to identify and quantify any toxic photoproducts that are formed under well-defined conditions. ICH Q1B (1) has been adopted throughout the world as the internationally accepted guideline for photostability testing of new drug ...
Amlexanox is used in the treatment of minor aphthous ulcers (canker sores). A specific HPLC-FL assay method for the determination of amlexanox in human serum was therefore developed and validated according to the current industry guidelines.1 The calibration range for the method is 5-250 ng/mL.
Pioglitazone is a prescription drug of the class thiazolidinedione with hypoglycemic (antihyperglycemic, antidiabetic) action and is used for the treatment of diabetes mellitus type 2 in monotherapy. It is usually administered in combination with sulfonylurea, metformin, or insulin. Pioglitazone is typically assayed with traditional LC-MS/MS methodologies. Here we present validation data for ...
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 ...
What is an antibody? An antibody is an immunoglobulin protein, secreted by B lymphocytes, that is present in serum or body fluid and combines specifically with an antigen. Antigens are classically defined as any foreign substance that elicits an immune response. An antigen that produces an adaptive immune response after injection into an animal is an immunogen. Immunogens can be designed so that ...
Apomorphine (5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo [de,g]quinoline-10,11-diol) is a dopamine receptor agonist under development for the treatment of erectile dysfunction.The purpose of this study was to characterize the binding of apomorphine to plasma proteins from humans and various animal species (mouse, rat and dog) of each gender.The binding of apomorphine to plasma proteins was evaluated ...
Company descriptions and contact
information are quoted
from the company's website or other promotional information. JAZ'D is not responsible for
the accuracy
of this information. Unless specifically noted, JAZ'D is not sponsored by, affiliated with
or otherwise
connected with any of the listed companies.
