Protein purification is a series of processes intended to isolate one or a few proteins from a complex mixture, usually cells, tissues or whole organisms. Protein purification is vital for the specification of the function, structure and interactions of the protein of interest. The purification process may separate the protein and non-protein parts of the mixture, and finally separate the desired protein from all other proteins. Ideally, to study a protein of interest, it must be separated from other components of the cell so that contaminants will not interfere in the examination of the protein of interest's structure and function. Separation of one protein from all others is typically the most laborious aspect of protein purification. Separation steps usually exploit differences in protein size, physico-chemical properties, binding affinity and biological activity. The pure result may be termed protein isolate.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use.
Consumer services refers to the formulation, deformulation, technical consulting and testing of most consumer products, such as food, herbs, beverages, vitamins, pharmaceuticals, cosmetics, hair products, household cleaners, paints, plastics, metals, waxes, coatings, minerals, ceramics, construction materials plus water, indoor air quality testing, non-medical forensic testing and failure analysis.
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.
In chemistry, fine chemicals are complex, single, pure chemical substances, produced in limited quantities in multipurpose plants by multistep batch chemical or biotechnological processes. They are described by exacting specifications, used for further processing within the chemical industry and sold for more than $10/kg. The class of fine chemicals is subdivided either on the basis of the added value, or the type of business transaction, namely standard or exclusive products.
A tree nut allergy is a hypersensitivity to dietary substances from tree nuts and edible tree seeds causing an overreaction of the immune system which may lead to severe physical symptoms. Tree nuts include almonds, Brazil nuts, cashews, chestnuts, filberts/hazelnuts, macadamia nuts, pecans, pistachios, shea nuts and walnuts.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia.
Micromeritics is the science and technology of small particles pioneered by Joseph M. DallaValle. It is thus the study of the fundamental and derived properties of individual as well as a collection of particles. The knowledge and control of the size of particles has importance in pharmacy and materials science. The size, and hence the surface area of a particle, can be related to the physical, chemical and pharmacological properties of drugs. Clinically, the particle size of a drug can affect its release from dosage forms that are administered orally, parenterally, rectally and topically. The successful formulation of suspensions, emulsions and tablets; both physical stability and pharmacological response also depends on the particle size achieved in the product.
Cytel is a multinational statistical software developer and contract research organization, headquartered in Cambridge, Massachusetts, USA. Cytel provides clinical trial design and implementation services, and statistical software products primarily for the biotech and pharmaceutical development markets.
The Queen's Award for Enterprise: International Trade (Export) (2003) was awarded on 21 April 2003, by Queen Elizabeth II.
Sulfoaildenafil (thioaildenafil) is a synthetic drug that is a structural analog of sildenafil (Viagra). It was first reported in 2005, and it is not approved by any health regulation agency. Like sildenafil, sulfoaildenafil is a phosphodiesterase type 5 inhibitor.
Ultrapure water (UPW), high-purity water or highly purified water (HPW) is water that has been purified to uncommonly stringent specifications. Ultrapure water is a term commonly used in manufacturing to emphasize the fact that the water is treated to the highest levels of purity for all contaminant types, including: organic and inorganic compounds; dissolved and particulate matter; volatile and non-volatile; reactive, and inert; hydrophilic and hydrophobic; and dissolved gases.
Eurogentec is a biotechnology supplier, based in Belgium, that specializes in genomics and proteomics kits, reagents, and certain biologics. It was founded in 1985 as a spin-off from the University of Liège. Eurogentec operates two licensed contract manufacturing organization facilities in Belgium which produce custom biologic and oligonucleotide products mainly for European pharmaceutical companies, but also holds a license from the U.S. FDA to export a commercial protein product to the U.S.. These products are used to diagnose and treat various conditions.
Aurobindo Pharma Limited is an Indian multinational pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's area of activity includes six major therapeutic and product areas: antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterologicals, and anti-allergics. The company markets these products in over 125 countries. Its marketing partners include AstraZeneca and Pfizer.
Ara h 1 is a seed storage protein from Arachis hypogaea (peanuts). It is a heat stable 7S vicilin-like globulin with a stable trimeric form that comprises 12-16% of the total protein in peanut extracts. Ara h 1 is known because sensitization to it was found in 95% of peanut-allergic patients from North America. In spite of this high percentage, peanut-allergic patients of European populations have fewer sensitizations to Ara h 1.
Biotechnology in India is a sunrise sector within the Indian economy. Agencies of the Government of India concerned with the biotechnology industry include the Department of Biotechnology and the proposed Biotechnology Regulatory Authority of India. As of 2022, the sector is valued at $80 billion. Biotechnology in India is in a growth phase and the sector is expected to be valued at $150 billion by 2025 and surpass $300 billion in value by 2030.
HAL Allergy Group is a pharmaceutical company that develops, produces and sells products for allergy diagnostic and allergen immunotherapy (AIT). The research facilities and headquarters are located at the Leiden Bio Science Park, Netherlands.
Host cell proteins (HCPs) are process-related protein impurities that are produced by the host organism during biotherapeutic manufacturing and production. During the purification process, a majority of produced HCPs are removed from the final product. However, residual HCPs still remain in the final distributed pharmaceutical drug. Examples of HCPs that may remain in the desired pharmaceutical product include: monoclonal antibodies (mAbs), antibody-drug-conjugates (ADCs), therapeutic proteins, vaccines, and other protein-based biopharmaceuticals.
Arven Pharmaceuticals is a Turkish pharmaceutical corporation headquartered in Istanbul established as a subsidiary of Toksöz Group in 2013. Arven's primary focus is development and production of high-technology inhaler and biotechnology products. The company is specialized on difficult to make products. Arven is the first Turkish company developing biosimilars for global markets, including the US and EU.
Rentschler Biopharma SE is a contract development and manufacturing organization (CDMO). It is part of Dr. Rentschler Holding GmbH & Co. KG and its employees make up the majority of the 1300 workers employed by the parent organization.
