ABOUT EVONIK

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.

Contact us now to order your sample kit.

Microbial fermentation

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.

CONTACT INFORMATION

Evonik Corporation

2 Turner Place

Piscataway, NJ 08854

UNITED STATES

Phone: (732) 981-5021

Contact: Francine Clark

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