- Home
- Services
- usa georgia
- drug master file document production
Refine by
Drug Master File Document Production Services Available In Usa Georgia
83 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 ...
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: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 ubiquitous task in characterizing the ...
Manufactured by:Perrery Farmaceutici S.r.l. based inPescantina (VR), ITALY
Pharmaceutical innovation is a complex creative process, which involves much more than, in fact, research. An important task of the system of creation and introduction of new drugs into production is to ensure interrelation with other enterprise processes related to the drug life-cycle. This approach makes it possible to ensure the quality of the product along the whole technological chain, that ...
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 ...
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 of prescription and over-the-counter drug products approved for sale ...
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 ...
by:Ardena Holding NV based inMariakerke, BELGIUM
Our services include: Primary packaging of in-house or externally produced drug product (capsules, tablets, …) in different types of containers (bottles, tubes, sachets, …). Secondary packaging including patient kit assembly and labelling ready for use in the clinic. Use of tamperproof primary and secondary packaging materials. Preparation and translation of multi-language label ...
Manufactured by:Rentschler Biopharma SE based inLaupheim, GERMANY
Rentschler Biopharma’s strategic alliance with Leukocare offers best-in-class formulation development considered at every step of the biopharmaceutical development and manufacturing process. ...
by:Ardena Holding NV based inMariakerke, BELGIUM
At Ardena, we are experts in writing scientific and technical reports using a dossier-centric approach. This means we keep the final dossier submission in mind throughout to ensure consistency, completeness and ...
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, ...
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, selecting a suitable buffer to maintain a constant pH ...
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 ...