Refine by
Drug Substance Services
57 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:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
Commercial manufacturing under full cGMP conditions with speed, efficiency and exceptional quality, plus flexibility to adapt to changes in your market and mission. At Patheon there is no such thing as good enough. We will never stop working to optimize and intensify your process to increase outputs and reduce timelines and capital expenditure. We are continuously making investments in capacity, ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
In late clinical phases, and as part of the establishment of your commercial supply, Patheon provides a complete validation package according to regulatory and cGMP ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
Your molecule has the power to change lives and shape the future. Let our biologics experts show you how to speed development and unleash the potential of your discovery. Patheon, by Thermo Fisher Scientific, offers you the flexibility and speed to help you get there ahead of schedule while maintaining the highest ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
Establishing the best synthetic route for your molecule is the basis for a reliable supply throughout the product’s life cycle. During route scouting, the following considerations are important when selecting the optimal pathway: Safety, Efficiency, purity and costs, Ease of optimization and scale up, IP review, Security of supply of raw materials, Impact on waste and the ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
Comprehensive upstream process development capabilities, including cell line development, and a commitment to innovation, quality and service, make us the ideal partner for the process development of your mammalian cell culture projects. Our expertise spans multiple commercial cell lines, including CHO (Chinese Hamster Ovary), as well as cGMP cell ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
Broad experience and access to the latest technological capabilities are essential for today’s increasingly complex API development and manufacturing. By partnering with Thermo Fisher Scientific, you’ll work directly with scientists with deep chemistry knowledge and many years of experience in successfully supporting early and later phase clinical development programs. Our experts ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
At Thermo Fisher Scientific, our people pride themselves on solving your API development challenges. Our objective is to help speed your molecule through early phase trials and prepare you for commercial success, faster. Whether you start working with us in early phase or late, we draw on years of experience and deep expertise to achieve industry-leading performance. Whether you need small ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
Repeatable, High Quality and Robust Process Design; We offer an in-depth understanding of reaction profiles and the quality and physical form of starting materials, intermediates and the final product are critical components of API (active pharmaceutical ingredient) development. To support route scouting and process development activities and accelerate your clinical programs, we provide a ...
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: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:BIOVECTRA based inCharlottetown, PRINCE EDWARD ISLAND (CANADA)
BIOVECTRA’s analytical services group supports GMP and CMC requirements from early development to validation of commercial processes and continuous process verification, all along the life cycle of your programs. Our capabilities include regulatory-driven, phase-appropriate testing for both small molecules APIs and biologic drug substances. They cover ...
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. ...
Manufactured by:CD Formulation based in, NEW YORK (USA)
Preformulation is an investigation of physical and chemical properties of a drug substance when used alone or combined with excipients. Early prediction of these properties will generate information useful to the formulator in developing stable and safe dosage forms with good bioavailability. At CD Formulation , our preformulation services are equipped with ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
We understand the needs of companies with an exciting compound in the discovery pipeline, but with limited amounts of drug substance. We have developed methods for carrying out formulation screening studies with as little as several mg of drug substance. These methodologies can be used to formulate new drugs for ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
.* By pairing this experience with a full range of analytical, formulation and dosage form technologies and solutions, Patheon can tailor a lean drug development program precisely suited to your molecule and business. One that will accelerate your project to first-in-human studies, and beyond when fully integrated with our comprehensive commercial supply and drug ...
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: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 ...