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. 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.
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that 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. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
Freeze drying, also known as lyophilisation or cryodesiccation, is a low temperature dehydration process that involves freezing the product, lowering pressure, then removing the ice by sublimation. This is in contrast to dehydration by most conventional methods that evaporate water using heat.
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 biologic(al) 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.
Peanut allergy is a type of food allergy to peanuts. It is different from tree nut allergies, with peanuts being legumes and not true nuts. Physical symptoms of allergic reaction can include itchiness, hives, swelling, eczema, sneezing, asthma attack, abdominal pain, drop in blood pressure, diarrhea, and cardiac arrest. Anaphylaxis may occur. Those with a history of asthma are more likely to be severely affected.
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, but are not limited to, 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 of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia.
The term micromeritics was given to the science and technology of small particles by J. 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 is of importance in pharmacy and materials science. The size, and hence the surface area of a particle, can be related to the physical, chemical and pharmacologic 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 pharmacologic response also depends on the particle size achieved in the product.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
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 chemical compound 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.
NSF International is an American product testing, inspection and certification organization based in Ann Arbor, Michigan.
Eurogentec is an international biotechnology supplier, based in Belgium, that specializes in genomics and proteomics kits and reagents as well as cGMP biologics. The company was founded in 1985 as a spin-off from the University of Liège. Eurogentec's contract manufacturing organization facilities are licensed by the Belgian Ministry of Health to produce clinical trial and commercial biopharmaceutical material and also licensed by the US FDA to manufacture a commercial recombinant protein product for the US market. Eurogentec operates two manufacturing facilities in Belgium that provide custom biologics and oligonucleotide-based components for diagnostic and therapeutic/prophylactic applications.
Aurobindo Pharma Limited is an Indian pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad, India. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s area of activity includes six major therapeutic/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.
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 and strives to develop quality products. Arven is the first Turkish company developing biosimilars for global markets, including USA and EU.
