A GLOBAL DEVELOPMENT PARTNER AND ENABLING SOLUTIONS PROVIDER
Evonik serves as a global development partner and solutions provider to life science companies to help them transform complexity into value. We bring together a broad, versatile range of core competencies, a trusted global network of sites, and strong technical expertise to support you in the development, scale-up and manufacturing of cell and gene therapies and other advanced biotechnologies.
Areas of market leadership include high-purity amino acids, cell culture ingredients, lipid nanoparticle and polymeric-based drug delivery, tissue engineering, and biomaterials such as bioresorbable polymers and recombinant collagen. We are also one of the world's leading CMOs for protein fermentation, APIs and biomaterials, with extensive formulation and process development support for large or complex projects.
Amino acids and derivatives
Evonik is one of the world’s leading and most trusted suppliers of pharmaceutical amino acids. For more than 40 years, customers have been leveraging our broad portfolio of highly pure natural and non-natural pharmaceutical amino acids, salts and derivatives. Our strong backward integration for starting materials manufactured at our large-scale fermentation facilities, can help to strengthen supply security and streamline your complete supply chain.
Evonik is far more than just a preferred global supplier of high purity amino acids, derivatives and peptides. We also serve as a development partner and solutions provider to many of the world’s pharmaceutical, biotech and nutraceutical customers. Our broad mix of core competencies across chemistry, biotechnology, drug delivery and cell culture uniquely position us to create long-term value. Customized amino acid solutions or regulatory services are provided in a range of areas including particle design, purification, packaging and analytical testing.
cQrex® cell culture solutions with industry recognized benefits
cQrex® is Evonik’s market-leading brand of cGMP-grade cell culture ingredients that are used by pharmaceutical and biotech companies to boost cell culture performance. Commercially proven for reliable media performance across countless biological programs, our cQrex® portfolio features a range of peptides and keto acids that we designed to address key issues in mammalian cell culture. The foundation stone for such outcomes are high-quality and animal origin-free amino acids, which have earned the industry’s finest reputation for batch-to-batch reproducibility at any clinical or commercial scale. All cell culture ingredients can be customized on-demand to address specific formulation requirements. In addition to screenings and booster development services, cQrex® customers can also benefit from our strong local knowledge of cell culture markets worldwide.
The cQrex® portfolio of dipeptides has been developed to provide customer solutions to the most challenging problems encountered with certain amino acids in high-performing cell culture processes. Based on their superior solubility, chemical stability and metabolic bioavailability, they have become essential tools in media development.
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Evonik is one of the world’s leading custom contract manufacturing organizations for the production of high-quality substances including advanced food ingredients, cosmetics, nature-identical materials and APIs that leverage microbial fermentation.
- A comprehensive array of services from strain development through to large-scale commercial production
- Experience that spans more than 30 years
- Helped to bring to market more than 25 commercial products based on fermentation and biocatalytic technologies
- More than 4,000m³ of fermentation capacity across multiple high-quality sites, including flexible downstream processing
- Enzymatic chemistry expertise with >20 different enzymes applied at production scale
- A strong record in the development of new enzyme platforms (bacteria, algae, fungi)
One of the world’s leading CDMO’s for complex parenteral drug products
Evonik has established strong core competencies across more than six drug delivery technologies that are utilized with complex parenteral drug products. The breadth and versatility of this portfolio uniquely positions us to serve as a CDMO partner that can select the perfect technology to match your specific drug, formulation and application requirements. For polymeric-based parenteral drug products targeted for systemic or local delivery across a range of administration routes, we can offer a range of technologies include microparticles, nanoparticles, micelles, solid implants and in situ forming implants. Each of these dosage forms can be combined with various excipients and process technologies to match your target release profile over duration periods from days or weeks to more than a year. For lipid-nanoparticle (LNP)-based drug products, we have three decades of liposomal expertise across a range of areas including nucleic acids, cytotoxic and high potency substances for therapeutic areas such as oncology, and synthetic vaccines.
Our parenteral CDMO services and solutions can add value at any product development stage including feasibility studies, excipient selection and supply, formulation development, process development and scale-up, clinical supply, QbD process characterization, GMP manufacturing and aseptic filling. By leveraging this broad portfolio of CDMO services, we can help ensure parenteral drug products, including those with highly potent APIs and controlled substances, are not only safe and efficacious, but can be efficiently reproduced at any clinical and commercial scale.
Our cGMP CDMO facilities in Birmingham, Alabama and Vancouver, Canada can support the aseptic filling of parenteral drug products in powder, liquid and suspension form into vials across a range of clinical and commercial batch sizes. Aseptic filling occurs in ISO 5 (Grade A) isolators, with facilities designed for use with highly potent products (> 0. 1 ug / m3) and controlled substances (Schedule III-V). A versatile combination of aseptic filling lines is available to support your specific batch size and drug product requirements. A new automated, highly modular commercial filling line suitable for vial sizes up to 50mL features integrated segments for washing and sterilization, filling, lyophilization, crimp and seal, and external vial washing. A range of other aseptic lines suitable for clinical scale batch sizes are also available for use with liquids, suspensions and powders.
Key differences exist between liposomes and lipid nanoparticles (LNPs), not only in their target applications, but with their actual morphology, composition, and manufacturing process.
How To Get The Most Out Of Your Cell Therapy Media Applications By The Addition Of Highly Pure L-Carnosine
Cell-based, engineered tissues are poised to make significant contributions in the field of regenerative medicine, and also in the development of a more sustainable global food supply through the use of cultured meat.
Reducing The Surface Friction Of Medical Devices - A New Functional Application For A Commercial Biomaterials Surface Modification Technology
Devices such as introducer sheaths, delivery catheters, endoscopes, and neurovascular microcatheters aim to minimize trauma during insertion and removal, reduce tissue inflammation, enable maneuverability through tortuous blood vessels, and improve patient comfort. Surface properties should promote smooth movement between certain device components.
Polymeric formulations such as intra-ocular implants designed for the precise intravitreal delivery of drug products represent one of the most promising, yet challenging, areas of pharmaceutical focus.
Reformulation Is Much Easier Than Developing A New Injectable Drug Product. So Why Aren’t We Doing It More?
With the significant financial costs and clinical risks involved in bringing a new injectable drug product to market, why isn’t reformulation or repurposing being used more often to meet these challenges? This interview with Dr. Tom Tice, one of the world’s leading experts on extended release injectables and implants, reviews current and emerging areas of reformulation focus and some best practices to get your strategy right.
With the right selection of dipeptides, keto acids, special amino acids or other derivatives at hand, biopharma companies can realize substantial process improvements.
The potential of lipid nanoparticle-based drug delivery technologies to enable a new generation of medicines was made clear in 2020 when the first two mRNA vaccines for COVID-19 were rapidly developed and authorized for emergency use. What other applications are now being explored for such delivery technologies? Dr. Jay Natarajan, Director of R&D, competence center for LNP technology, answers questions in this interview.
Reviewing Formulation Technologies For Nanomedicines: How To Select The Right Technology For Your API
Demand for the formulation development and manufacturing of nanomedicines is surging like never before. During a company's nanomedicine development program, selecting the right drug delivery technology is key. Deciding which technology is most suitable for an API must be determined by a complex array of factors.
Recent improvements in our understanding of the human genome, together with advanced DNA editing and analytical tools, position the cell and gene therapy market for explosive growth. However, these technologies have significant formulation development, cGMP manufacturing and aseptic filling challenges. The engagement of a CDMO partner with a broad portfolio of delivery technologies, a strong formulation track record and manufacturing flexibility is the preferred pathway for success.
Depending on the cell line, clone, product and media formulation used for biopharmaceutical production, it can be helpful to evaluate additional glutamine dipeptides to maximize performance.
Isabel Wahl, Head of Evonik’s RESOMER development lab, discusses a new bioresorbable copolymer combining mechanical strength with rapid degradation for wound healing and pediatric devices.
This interview with Dr. Lars Geiger, Director of Global Projects at Evonik, reviews key trends and scale-up challenges to manufacture a substance via fermentation.
Amino acids used in biopharma processes must be animal-origin free, governed by strict change control policies and utilize precise processes to eliminate endotoxins and heavy metals.
While the solubility of free L-Cysteine is high at neutral pH, the applicable concentration in basal and feed media is limited. Read more about an available solution for solubility and performance challenges.
The production of recombinant collagen made via fermentation-based processes addresses the market need for collagen that is safe, sustainable, reproducible, and acceptable to consumers.
Because L-Tyrosine is an important amino acid for protein synthesis and cellular metabolism, finding a solution to its solubility challenge can be critical to maximize process performance.
Enteric coatings have been utilized with oral drug products for more than 60 years to protect acid-sensitive APIs from gastric acids and prevent gastric irritation by aggressive APIs. However, for many complex drug products targeting the small intestine or ileocolonic region, enteric protection on its own is insufficient to maximize absorption and enhance bioavailability. A new and unique oral drug delivery technology could be the solution.
Many biotechnology, food and advanced material developers are now seeking to develop and commercialize their protein-based products utilizing microbial fermentation processes.
Cell culture media used in biopharma production have come a long way in recent decades. This interview discusses key solubility, stability and other challenges that many biopharma companies still face.
After more than 25 years of commercial use with almost 20 parenteral drug products, lipid nanoparticles (LNPs) are having a breakout moment. While LNPs are now a proven drug delivery technology to penetrate target cells and ensure release for reliable systematic or local delivery, their true market potential as a gene and cell therapy enabler has only become clear to many since COVID-19.
Traditional filling lines lack the necessary versatility to address the growing number of complex and personalized parenteral drug products that are now being brought to market. Evonik has recently qualified a new modular aseptic filling platform that will efficiently fill drug products in powder, liquid, suspension or combination form.