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Drug Master File Document Production Services In Usa New York
19 services found
by:Alfred E. Tiefenbacher (GmbH & Co. KG) based inHamburg, GERMANY
In addition to offering an extensive portfolio of in-house developed generic drug products across indications, AET has started the development of biosimilars and innovative product designs. AET provides a comprehensive service from project concept (including global portfolio and IP strategy and competitive product design) via product development and registration through to production, timely ...
Manufactured by:Creative Biogene based inShirley, NEW YORK (USA)
Therapeutic antibodies are highly regarded for their high affinity, specificity, low immunogenicity, and ability to target a wide range of biological molecules. Currently, mammalian cells, including Sp2/0, NS0, HEK293, and CHO cells, are primarily used for the production of therapeutic antibodies, with CHO cells accounting for over 70% of the production due to their complex posttranslational ...
Manufactured by:Alfa Chemistry based inNY, NEW YORK (USA)
Alfa CDMO provides global CDMO services in the development and manufacturing of biopharmaceuticals, including mAbs, recombinant proteins, ADCs and bispecifics. We offer our partners contract services from DNA to finished drug product. Our technical expertise allows us to provide effective high-quality solutions for our partners biomanufacturing needs. In addition, Alfa CDMO delivers our ...
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
Bioavailability refers to the degree and speed at which a drug is absorbed into the blood circulation. There are ongoing challenges with poorly water-soluble drugs and have failed to reach the market due to their poor water solubility. CD Formulation has developed a range of technologies and formulation expertise to improve the solubility and bioavailability of these drugs, helping customers find ...
Manufactured by:Alfa Chemistry based inNY, NEW YORK (USA)
The stability of pharmaceutical products refers to the ability of APIs and preparations to maintain their physical, chemical, biological and microbiological properties. The purpose of stability study is to investigate the changes of the properties of APIs or preparations with time under the influence of temperature, humidity, light and other conditions, so as to provide a scientific basis for the ...
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
Light stability testing in the pharmaceutical industry is necessary to ensure the potency, efficacy and safety of manufactured products in clinical use. Photostability testing of APIs and products is performed according to ICH Q1B guidelines, and the selection of an appropriate light source is an important consideration for consistent results. Photodegradation of drugs in products is a function ...
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
CD Formulation's Contract Development and Manufacturing (CDMO) division is a leader in drug development and drug delivery pathway development, offering services such as bioresorbable particle system development. CD Formulation also offers integrated services from evaluation of drug formulation to drug product development, scale-up production, and commercial manufacturing, our pharmacy experts ...
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
In order to ensure the safety of drug product quality, the packaging system that comes into direct contact with the drug product needs to meet compatibility requirements. Compatibility studies refer to the process of evaluating packaging components or systems that are in direct contact with the drug product without serious, or unacceptable, changes in effectiveness and stability of drug products, ...
Manufactured by:Creative Biolabs based inShirley, NEW YORK (USA)
Biological drugs are pharmaceutical drug product manufactured in, extracted from or semi synthesized from a living organism or from biological sources. Our professional scientists have rich experience in biological and pharmacological research of multiple biological drugs including peptide drugs, protein drugs, antibody drugs, antimicrobial drugs, vaccines as well as drugs involved in different ...
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
CD Formulation's self-emulsifying drug delivery system service can evaluate the bioavailability of drugs and suggest suitable product solutions. Our professional team has the ability to establish and validate analytical methods, determine oil/water partition coefficients, investigate the equilibrium solubility of drugs in water, oil, surfactants, and provide co-surfactant selection. After the ...
Manufactured by:Profacgen based inShirley, NEW YORK (USA)
Biopharmaceutical products are synthesized by living cells, and hence during the purification process the substrates for growth, host cell components and product variants must be ...
Manufactured by:Creative Bioarray based inShirley, NEW YORK (USA)
Advances had been made towards the use of in vitro human skin equivalents/models for dermal drug and cosmetic product testing. In vitro Skin Models (Human Skin Equivalent, FTSK, HSE) used under defined test conditions offer several advantages: i) since most models are composed of primary human cells, inter-species extrapolation is avoided; ii) in contrast to human skin specimens, repeated ...
Manufactured by:Creative Biolabs based inShirley, NEW YORK (USA)
Protein drugs are protein products with certain biological activities for the prevention and diagnosis of diseases. They can be derived from plants and animals, or developed through biotechnology research. Protein drugs in a broad sense include all products whose chemical nature is protein or polypeptide, such as hormones, growth factors/cytokines, plasma proteins, enzymes, coagulation factors, ...
Manufactured by:Spectrum Plastics Group, A DuPont Business based inAlpharetta, GEORGIA (US) (USA)
With hundreds of materials and tools in stock and countless configurations readily available, we can rapidly produce prototypes to accelerate your extrusion, catheters, additive manufacturing, and 3D medical printing development ...
Manufactured by:Creative BioMart based in, NEW YORK (USA)
Creative Biomart provides drug analysis service for pre-clinical drugs and natural products on their physical and chemical properties. Our services include three main assays: pre-clinical pharmaceutical property analysis, pharmacokinetics analysis & bioanalysis, andnatural product ...
by:Bureau Veritas North America, Inc. based inNew York, NEW YORK (USA)
What are APIS and should I Be Concerned about Them? Active pharmaceutical ingredients (APIs) are defined as any substance or a mixture of substances that when used in the production of a drug, becomes an active ingredient in the drug product. Unlike most chemical hazards in the workplace for which health effects upon exposure are incidental, the purpose of an API is to have the maximum biological ...
Manufactured by:Pluristem Therapeutics Inc. based inHaifa, ISRAEL
Acute Radiation Syndrome (ARS) involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells, as well as to other systems and organs. Severe damage to bone marrow makes victims vulnerable to life-threatening hemorrhage, infection and anemia. ...
Manufactured by:CD Bioparticles based inShirley, NEW YORK (USA)
CD Bioparticles offers one-stop drug-carrier complex analysis package service including drug in vitro testing using advanced techniques. Our experienced scientists have created a comprehensive platform to measure the drug in vitro testing from different ...
Manufactured by:Pluristem Therapeutics Inc. based inHaifa, ISRAEL
Bone marrow deficiency refers to a condition in which the hematopoietic stem cells in the bone marrow fail to produce enough, or produce abnormal, red blood cells, white blood cells and platelets. Hematopoietic cell transplantation (HCT), the transplantation of multipotent hematopoietic cells, is a standard treatment in various malignant and non-malignant conditions. Transplant patients are ...