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Drug Substance Services In Europe
25 services found
by:Ardena Holding NV based inMariakerke, BELGIUM
The physico-chemical characterisation of your drug substance is the basis of a successful development program. Navigating through the pre-clinical phase is not an easy task. Many compounds fail in early phase development because they are not bioavailable. It is our job to use our pre-formulation development expertise to give your molecule the best chance of ...
Manufactured by:IDT Biologika based inDessau-Rosslau, GERMANY
We have GMP manufacturing facilities in Europe and the United States, offering capabilities from early-stage development through clinical to commercial scale. In Drug Substance Manufacturing, we provide master / working cell banks, master / working virus seeds, manufacture of bulk drug substance, and multiple manufacturing ...
Manufactured by:IDT Biologika based inDessau-Rosslau, GERMANY
As one of the world’s leading CDMOs for vaccines, gene and immune therapeutics, and other biologics, IDT Biologika has a wealth of experience in the biological processes and technologies used to produce Viral Vaccines, Viral Vectors, and Oncolytic ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
Most drug substances are marketed as crystalline material. Having a crystalline drug candidate is beneficial to development processes and simplifies registration. We offer crystallization screening services and also complete crystallization development ...
Manufactured by:CELONIC Group based inBasel, SWITZERLAND
Using such a regulatory-compliant Quality by Design (QbD) step at an early stage will result in an accelerated and risk-mediated downstream process (DSP) development. It will also generate a more stable final drug substance formulation that, ideally, results in a consistent formulation for drug substances and products. ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
The analytical aspects of pharmaceutical development are demanding, as in contrast to pure drug substances, matrix effects need to be taken into account. As one of the most skilled and experienced companies in the field of pharmaceutical development analytics, we can meet your ...
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 ...
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 state-of-the-art fermenters, harvesting equipment, and a ...
Manufactured by:Recipharm AB based inStockholm, SWEDEN
We have extensive experience and a wide range of analytical and synthetic equipment to conduct successful impurity identification for drug ...
Manufactured by:SEQENS Group based inÉcully, FRANCE
Seqens provides active pharmaceutical ingredient (API) and drug substance development services to support emerging and large pharmaceutical customers in human and animal health with their pharmaceutical and biotechnology applications for complex, niche and small molecule programs through two main R&D locations in the regions of Boston and ...
Manufactured by:Rentschler Biopharma SE based inLaupheim, GERMANY
Our drug substance manufacturing in state-of-the-art cGMP facilities meets the highest standards of the biopharmaceutical industry. To guarantee this, we follow high-quality standards within our internal processes and our team. Comprehensive quality management and precise, as well as reliable quality control, ensure excellent performance and results. ...
Manufactured by:ExcellGene SA based inMonthey, SWITZERLAND
Have you been limited a lack of tox material to properly design your pre-clinical toxicology studies in animals? We will help you plan experiments without the worry of running short. We can deliver up to 500 grams of drug substance from a single batch, in 8 months or less. Our scientific foundation is built on expert knowledge, dependable quality, and timely ...
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (USA)
Our biologics analytical services can be provided as a standalone service or integrated into development and manufacturing. We provide services for drug substance, drug product, and intermediates, both New Biologic Entities and Biosimilars/Biobetters and can provide support throughout the drug development pipeline, from ...
by:Vetter based inRavensburg, GERMANY
Learn how we work with you to design a flexible, scalable, reproducible, and efficient manufacturing processes for your clinical ...
Manufactured by:Creative Biolabs based inShirley, NEW YORK (USA)
Microorganisms, also called microbes, are the collective name of all tiny organisms that are invisible to the naked eye. Harmful microorganisms are called pathogenic microorganisms which can cause diseases. Antimicrobial drugs refer to any substance that inhibits and kills pathogenic microorganisms and are used to treat infectious diseases. They can interfere ...
Manufactured by:Recipharm AB based inStockholm, SWEDEN
The flexibility, capacity and expertise to take care of your analytical requirements. At Recipharm,?our analytical experts are here to help you rapidly develop your molecule to successfully bring it to the clinical stage and ...
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. ...
Manufactured by:leon-nanodrugs GmbH based inMunich, GERMANY
DRIVING INNOVATION AT EVERY STAGE WITH OURPROCESS DEVELOPMENT EXPERTISE. WE SCALE UP ...
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:ProBioGen AG based inBerlin, GERMANY
Customer satisfaction is at the heart of our quality management system (QMS), which assures products and services of utmost quality. We place the highest priority on product integrity, safe GMP manufacturing, and regulatory compliance (EMA, FDA, ICH). Our best-in-class QMS is founded on state-of-the-art technologies for manufacturing and testing. It is operated by a highly educated and ...