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Drug Production Services
100 services found
by:BioConnection based inOss, NETHERLANDS
When you’re developing a finished dosage form, your project costs are most likely in a sound competition with your available funds. This is why choosing a CDMO is an important and long term decision. BioConnection can help you out with an oversight of the technology transfer and per-unit manufacturing cost. Let us also assist you with determining the often hidden costs: depending upon the ...
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 ...
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:Nanolytics GmbH based inPotsdam, GERMANY
In addition to self-association behavior (e.g. desired oligomerization), the conformational status of proteins and other biomolecules (e.g. denaturation, misfolded conformers) is crucial for understanding molecular functions and evaluate stability/safety/efficacy issues of drug products. Therefore, discriminating between size and conformation variants is an ...
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 ...
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: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: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: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 ...
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: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 ...
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. ...