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Drug Products Services In North America
63 services found
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: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 ...
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 ...
by:Nexreg Compliance Inc. based inLondon, ONTARIO (CANADA)
Nexreg can work with your company to develop drug product labels which meet Canadian requirements. As well, Nexreg's team of experts will complete the DIN Submission Certification form required by the Therapeutic Products Directorate (TPD) of Health Canada. The Drug Identification Number (DIN) is the number located on the label ...
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 ...
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 ...
by:Lifecore Biomedical, Inc. based inChaska,, MINNESOTA (USA)
Drug product formulation development starts with an understanding of the drug substance. Our experts work with you to define and understand the anticipated use, desired performance criteria, characteristics of the drug product, distribution, storage, and ...
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 ...
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 ...
by:Celegence LLC based inDowners Grove, ILLINOIS (USA)
Supporting client requirements from creation to maintenance of global and local drug product labeling. Regulatory Labeling regulations are essential for ensuring compliance of drug products to be used safely and with efficacy by patients. However, regulatory labeling compliance requirements can differ across regions and new ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Biological formulation development involves discovering solutions for the most bioactive, native protein delivery. It poses a myriad of challenges due to the fact biologics consist of generally large, complex molecules that complicate drug development. Biologics are at the forefront of many current medical advances. They have established a key position in the pharmaceutical market by ...
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: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 ...
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, ...
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 ...
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 ...
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 ...
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (USA)
Drug product development can be a daunting and expensive process. Biotech companies face many hurdles along the way, including the development and optimization of a scalable, commercially viable formulation while ensuring safety and efficacy of the final drug product. In order to receive regulatory approval, the manufacturing ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
A 505(b)(2) drug development project represents a streamlined regulatory strategy for many pharmaceutical products today. The provisions of 505(b)(2) were created to avoid unnecessary duplication of studies already performed on a previously approved product. A 505(b)(2) new drug application contains full safety and ...
Manufactured by:Precision NanoSystems based inVancouver, BRITISH COLUMBIA (CANADA)
Combining disruptive technology platforms with unparalleled genomic medicine development expertise, Precision NanoSystems’ Biopharmaceutical Services accelerates the development of lipid nanoparticle (LNP) formulations and drug products. ...