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Drug Production Services
85 services found
by:Ardena Holding NV based inMariakerke, BELGIUM
At Ardena, we guide our customers into making smarter formulation choices. Ultimately, this reduces the risk of clinical failure and ensures your product reaches the clinic rapidly via the most efficient route. Solving a problem and saving time Overcoming development challenges is our speciality. We work with customers to understand their product needs and develop the best possible formulation. ...
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:CELONIC Group based inBasel, SWITZERLAND
We offer comprehensive Fill & Finish services for liquid-formulated drug products – from aseptic filling to QC tests, labeling, packaging, storage, and release. Our solution-driven GMP-complaint processes come with unparalleled flexibility, fully-adaptable to the unique needs of our clients. Having completed over 300 GMP filling batches, our scientists ...
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:Advanced Microdevices Pvt. Ltd. (mdi) based inAmbala Cantt, INDIA
We comprehend and value the critical importance of establishing drug product wetted integrity test specifications to ensure filter efficiency. The drug product / process fluid, due to different components, may have different surface tension than the filter manufacturer specified wetting fluid, impacting the drug ...
Manufactured by:Advanced Microdevices Pvt. Ltd. (mdi) based inAmbala Cantt, INDIA
Our microbial retention studies qualify the filter under test to repeatedly produce a sterile filtrate with the drug product under simulated worst case process conditions in accordance to: USFDA CDER guidance document on Sterile Drug Products Produced by Aseptic Processing. PDA Technical Report No. 26, Revised 2008 on Sterilizing ...
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:Vetter based inRavensburg, GERMANY
Our experts provide the guidance, insight, and Vetter process documentation you need to prepare a Common Technical Document (CTD) for clinical trials of your injectable drug ...
Manufactured by:RheaVita based inGent, BELGIUM
During freeze-drying, biopharmaceutical and other products require protection against dehydration stress during freeze-concentration and drying. Therefore, a suitable formulation strategy is essential to guarantee the long-term stability of drug products. This strategy could include adding protectants to withstand the dehydration stress, ...
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:CD Formulation based in, 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:CD Formulation based in, 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 ...
by:Biovian Oy based inTurku, FINLAND
Biovian is a One-Stop-Shop CDMO for bacterial and yeast-based production of Drug Substances and Drug Products. Our microbial production services include GMP production of recombinant proteins and plasmid DNA for vaccines. The microbial GMP-manufacturing unit of Biovian is equipped with ...
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: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 ...