DRUG PRODUCT MANUFACTURING
Your drug substance and drug product custom manufacturing solution.
Decades of experience and a successful track record as a CMO have earned Evonik a place along the value chain of both large and small pharma developers and manufacturers around the world. From drug substance development to drug product clinical and commercial supply, we have the people, the infrastructure and the capacity to meet your manufacturing needs.
Spread across five production sites on three continents, our operations become your manufacturing platform. Our teams of chemists, biotechnologists, pharmacists and engineers become your experienced collaborators. We are fully in compliance with cGMP standards worldwide and our facilities are regularly audited. At the same time, we ensure maximum reliability and on-schedule delivery. As all facilities are wholly owned by Evonik, we maintain complete control over all stages of production worldwide and guarantee maximum security for your intellectual property.
FROM DRUG SUBSTANCE PRODUCTION …
We believe that the advantages of having a manufacturing partner for the drug substances your project requires go beyond the availability of state-of-the-art infrastructure. That is because the quality, consistency, reliability, and speed you get with Evonik come from decades of experience and an unswerving innovative drive. And decades of substantial investments in advanced technologies. That is why we can produce custom active pharmaceutical ingredients with the quality consistency and supply security that sets new benchmarks.
… TO DRUG PRODUCT MANUFACTURING WITH EXCELLENCE BUILT-IN
Our best-in-industry capabilities for manufacturing complex parenteral dosage forms are not just about technologies and facilities. At Evonik, custom manufacturing follows through on our core competencies in drug substance manufacturing, functional excipients and formulation development. Entrusting your drug product project to us means you benefit from our upstream experience and expertise. From engineering and scale-up to final product, terminal sterilization or aseptic manufacturing, our capabilities are as flexible as you need them to be. And if a highly potent API is involved, you will be relieved to know that Evonik’s primary and secondary containment systems set industry benchmarks, too.
Contract manufacturing of parenteral dosage forms
VOLUME FLEXIBILITY, CONSISTENT QUALITY, RELIABLE SUPPLY - BATCH FOR BATCH
Our idea of partnership is to be a natural extension of your own organization. At our facilities in Birmingham, Alabama, USA, and Vancouver, Canada it starts with the capability to manufacture a broad spectrum of complex parenteral dosage forms, such as:
Microparticles and nanoparticles
Final presentation is available in a range of vial sizes, from 2 to 50 ml. Solids are available in the gram to kilogram range. The unique strength of Evonik is that our custom manufacturing capacity naturally follows through on our core competencies in drug substance development, functional excipients and formulation development.
In accordance with FDA, EU, Japan and other regulatory guidelines, we understand pharmaceutical processing, melt-extrusion processing, microparticle/powder technology, emulsion science, fluid dynamics, and various product isolation techniques. This expertise enables us to bring in client processes and analytical methods, and transfer them to our state of the art production facilities for clinical supply manufacture. Whether the formulation was developed with Evonik or a third-party, it doesn't matter at which stage of your timeline you involve us or for how long: entrusting your drug product project to Evonik means you automatically benefit from our expertise and experience in all the areas that lead up to manufacturing. Unconditionally.
CLINICAL SUPPLY MANUFACTURING
Evonik has extensive experience in the production of clinical trial materials. Over the last several years, we produced and released over 400 GMP batches for Phase I - III clinical trials and multiple GLP batches for toxicology studies. These products ranged from microparticles and implants that were terminally sterilized to aseptically produced microparticle and liposome formulations.
Highly potent aseptic formulations using barrier technologies have also been produced for clinical trials. APIs have included small molecules: peptides that were terminally sterilized or manufactured aseptically and proteins that were manufactured aseptically. The scale of clinical production lots ranged from a few grams per lot to more than 75 kilograms per lot.
COMMERCIAL DRUG PRODUCT MANUFACTURING
Manufacturing is a core competency that is available for products developed for clients by Evonik and for products developed by third parties.
Evonik’s manufacturing competencies include the ability to manufacture clinical trial materials and commercial products for a broad range of parenteral dosage forms using aseptic manufacturing or terminal sterilization:
Injectable solid implants
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