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Drug Master File Document Production Services In Usa
62 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 ...
by:Lifecore Biomedical, Inc. based inChaska,, MINNESOTA (USA)
Depending upon the requirements of the drug product, a variety of filling conditions can be tested and equipment ...
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:Cambrex Corporation based inEast Rutherford, NEW JERSEY (USA)
Cambrex provides a seamless method on-boarding process to establish robust methodology at our sites. We have extensive equipment capabilities that allow us to support full release and routine testing. ...
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:ApiJect Systems, Corp. based inStamford, CONNECTICUT (USA)
Offering Design, Engineering and Testing of ApiJect’s High Volume Process for Manufacturing Single-Dose, Prefilled ...
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:Locus Biosciences, Inc. based inMorrisville, NORTH CAROLINA (USA)
We built a world-class biologics manufacturing facility, enabling the manufacture of our precision therapeutics while providing the capability to also manufacture gene therapy vectors and other advanced biologics. Our facility design allows for parallel production of multiple drug substances simultaneously, in isolated production suites, without risk of cross-contamination. It is optimized for ...
Manufactured by:ZebraSci Inc. based inTemecula, CALIFORNIA (USA)
The medical device community is continually faced with the challenge of providing patients with reliable solutions for drug delivery. One of the “go-to” delivery platforms are syringes. Glass or plastic syringes are often used in connection with Luer fittings for injection needles, adapters or transfer devices. Another common syringe platform is pre-filled syringes, filled with a ...
by:Lifecore Biomedical, Inc. based inChaska,, MINNESOTA (USA)
Lifecore has decades of experience, using its proprietary filtration system, filter sterilizing very high viscosity solutions (>100,000 cps sodium hyaluronate solutions) while conforming to industry standards for filter ...
Manufactured by:ApiJect Systems, Corp. based inStamford, CONNECTICUT (USA)
Our device and BFS manufacturing experts will work with your team to fill-finish your drug product in one of our customized prefilled drug delivery systems at scale. ...
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 ...
by:Revvity Gene Delivery (formerly SIRION Biotech) based inHamburg, GERMANY
At Revvity, we work with you to expedite the development of gene therapy vectors. ...
by:National Resilience, Inc. based inSan Diego, CALIFORNIA (USA)
As recombinant protein and monoclonal antibody treatments continue to provide promising pathways for both existing indications and new ones, Resilience has the clinical and commercial experience, expertise and capacity to be your preferred manufacturing partner. Regardless of which of our Biologics teams and facilities across North America take the lead on your project, our goals are the same: to ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
We understand that early assessment of a protein biopharmaceutical’s stability can be invaluable, even during pre-development. For drug substances and drug products all stability aspects can be monitored including long term and accelerated stability studies, in use studies, short term temperature excursion studies, and forced degradation studies according to ICH guidelines Q5C and Q1B. ...