EVONIK HEALTH CARE - YOUR COMPETITIVE ADVANTAGE
Evonik Health Care partners with the world’s pharmaceutical companies to transform complexity into value.
Our core competencies allow us to specialize where you need us most, ensuring access to the right people, products, and capabilities to streamline your path to market and improve commercial performance.
Evonik has served as a global development partner and solutions provider to the pharmaceutical industry for more than 60 years. Our broad portfolio of products, technologies and services is leveraged by more than 1,000 life science customers worldwide, including more than 90% of the world’s top pharmaceutical companies, to support the development, scale-up and supply of their APIs, formulations and drug products. With more than 50 core competencies that extend across chemistry, biotechnology and process engineering, as well as a global network of manufacturing sites and labs, we have the size, strength and versatility to address the specific needs of even the largest or most complex projects. Discover how we can reduce risk, improve quality, accelerate time to market, optimize product performance and strengthen supply security.
EVONIK PRODUCTS AND CUSTOM SERVICES
Functional excipients for oral solid dosage forms and controlled release parenterals
- EUDRAGIT® - functional polymers for oral drug delivery of drug products with immediate, delayed, controlled or many other complex release profiles
- RESOMER® - portfolio of bioresorbable polymers for controlled and specific administration of parenteral drugs for durations of up to 18 months
A global CDMO leader for advanced drug delivery
Evonik has been one of the world's leading CDMOs for many decades, helping pharmaceutical and biotech companies to release the true value of their oral and parenteral drug products.
- Modified release oral drug delivery formulation development including GI targeting
- Feasibility, pharmacokinetic, stability and other studies including analytical services
- Advanced cGMP clinical manufacturing services for complex oral solid dosage forms
- Complex parenteral drug delivery formulation development for systemic, targeted or localized delivery
- Process development, cGMP drug manufacturing and aseptic filling of parenteral drugs
- Polymer and lipid-based delivery technologies for injectables
- Technologies for small molecules, HPAPIs, peptides, proteins, nucleic acids, synthetic vaccines, controlled substances and more
- LIPEX® extruders for liposomal parenteral drug product manufacturing
Custom API and intermediates manufacturing
- Winner of the Life Science Leader CMO Leadership Awards 2020
- Western-centered manufacturing network
- Supply APIs, HPAPIs and intermediates from grams up to the largest commercial volumes
- Core competencies across chemistry, biotechnology and engineering
- More than 1,400m³ of cGMP reactor volume across a network of FDA-inspected sites in the U.S., Europe and Asia
- Process development and upscaling
- Leader in amino acids and derivatives
A broad portfolio of advanced technologies to address the specific needs of large or complex projects
- Continuous processing
- Highly potent API
- Microbial fermentation and strain development
- PEGs and mPEGS
- Carbohydrate Chemistry
- Polymer API
- Catalysis and Biocatalysis
- Chiral Chemistry
- Cryogenic Chemistry
Optimizing Gastric Resistance In Complex Oral Drug Products With Novel, Functional, Ready-To-Fill Capsules
Functional capsules can improve a targeted drug delivery strategy and allow the use of more sensitive active molecules. A newly launched platform of functional ready-to-fill hydroxypropyl methyl cellulose (HPMC) capsules are completely free from animal-derived products.
The selection of the right formulation is critical for the development of drug products for pediatric populations. The developmental status influences the dosage form and strength, taste or odor masking, and swallowability. Review some key factors to consider during initial formulation development.
The pandemic has highlighted vulnerabilities in the global supply chain that may be triggered by future logistical or political disruptions. To reduce risk, initial steps are being taken to review how to increase local production capacities and tighten potential supply chain gaps.
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.
About the size of a shipping container, a Modular Continuous Pilot plant features a highly flexible modular configuration that can enable the use of a wide range of reactor types within a small and highly cost-effective footprint.
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.
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.
Five Key Functional Challenges Can Affect Oral Drug Products With An Immediate Release Profile. Ready-To-Use Excipients Can Now Solve Them All.
The market for oral drug products with an immediate release profile continues to move towards the development of more complex dosage forms designed to address specific functional or application requirements. While each formulation is different, customers most commonly want solutions to some combination of these five key challenges.
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.
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.
Over the last decade, the potential of fermentation-based manufacturing has dramatically expanded, due to advances in synthetic biology and genetic engineering. Examine key trends and scale-up challenges to manufacture a substance via fermentation.
Few suppliers of standard or custom PEGs and mPEGs have the necessary competencies to address quality and purity requirements or to overcome other technical manufacturing challenges, such as the reliable handling of ethylene oxide, organic solvents, and initiators.
Several drug products utilizing continuous manufacturing processes have been approved by the FDA, with many others in clinical development. Review the challenges and opportunities for the use of continuous manufacturing for APIs and intermediates.
For pharma and biotech companies focused on the development of microbiome products, it's important to develop oral dosage forms that can deliver specific formulation or application outcomes.
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.
Dr. Andreas Meudt, the global head of Exclusive Synthesis for Evonik, shares his thoughts on key growth trends for HPAPIs and why more pharma companies are outsourcing their production to contract specialists.
To meet growing market demand for the use of protein-based products that have a sustainable ecological footprint, substantial efforts are now underway to utilize microbial fermentation-based processes to transition animal-derived sources such as meat, skin, silk, milk, and eggs.
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.
Poor solubility used to be one of the main showstoppers during the development of oral drug products. How can pharma companies minimize project risk and development costs, select the right excipients, equipment and process technologies to complement their API and dosage form, and hopefully also enable higher drug loadings and improve stability? Following are five key factors that companies should keep in mind to help ensure their path to solubility enhancement is as seamless and as low risk as possible.
Discover some of the key expectations of customers who are reviewing CMOs to support the development and upscaling of their next major project.