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API Contract Manufacturing Capabilities

A broad, flexible portfolio of advanced technologies to manage process development

The flexibility to address your specific project needs from process development to commercial scale

The number of small molecule projects based upon complex chemical compounds is growing rapidly within pharmaceutical market segments such as oncology. The synthesis of these highly specialized APIs, HPAPIs or intermediates can require a dozen or more process steps plus a combination of advanced technologies.
Evonik has combined its deep knowledge of chemical and biotechnological processes with a highly differentiated portfolio of advanced technologies to address every stage from process development through to commercial scale. The size and scope of this portfolio, including our expertise in continuous processes, gives us the flexibility to address the specific requirements of even the largest or most complex customer programs. As a result, your business can benefit from Evonik as a multifaceted company with our knowledge of technology and experience in certified system solutions.

High-potency API (HPAPI)
Evonik Health Care API Contract Manufacturing Capabilities: Highly Potent API

The world’s largest HPAPI capacity, with full project support from process development to large-scale manufacturing:

  • A total capacity of 170 m³

  • OEL down to 0.1 μg / m³ for small, medium or large-scale production

  • Reactor volumes from lab scale up to 7,600 liters

  • A broad range of reaction types covered

  • Able to concurrently manufacture seven HPAPI steps in parallel

  • Process development lab for HPAPIs and ultra-HPAPIs, with OEL down to 5 ng/m³

Continuous processing
Evonik Health Care API Contract Manufacturing Capabilities: Continuous Processing

More than 2/3 of our own products are manufactured using continuous processes, with comprehensive support from process development to customized production, separation and work-up:

  • Established process development capabilities with a broad variety of reactor technologies including microreactors, tube reactors, loop reactors, trickle-bed reactors plus CSTR and SMB

  • Continuous separation and work-up technologies including distillation, extraction, crystallization and membrane technologies

  • State of the art modular, continuous processing cGMP pilot plant in Germany

PEGs & mPEGs
Evonik Health Care API Contract Manufacturing Capabilities: PEGs & mPEGs

Custom-tailored PEG specialties for the highest quality standards:

  • Commercial-scale cGMP production sites in Germany and the U.S.

  • mPEG support from synthesis through to isolation, activation and conjugation

  • New mPEG lab and a pilot plant in Germany for process development and pilot-scale manufacturing of highly pure synthesis

Carbohydrate chemistry
Evonik Health Care API Contract Manufacturing Capabilities: Carbohydrate Chemistry

A unique portfolio for carbohydrate chemistry with decades of sugar modification expertise:

  • An expert in sugar derivatization, protective groups, and bioconversions

  • A broad technology range for nucleoside APIs

  • Fermentative production of oligosaccharides from kg to multi-ton scales

Polymer API
Evonik Health Care API Contract Manufacturing Capabilities: Polymer API

Polymer chemistry excellence applied to pharma applications:

  • A wide range of technology platforms including solution, suspension, emulsion, coordinative, radical, anionic, bulk and ring opening polymerization

  • More than 60 years of expertise in polymer development, optimization and scale-up

  • A network of U.S. and EU sites for the flexibility to support all polymer API process steps, with both batch and continuous process options available

Microbial fermentation
Evonik Health Care API Contract Manufacturing Capabilities: Microbial Fermentation

A global leader in microbial fermentation from strain development to commercial scale:

  • More than 4000 m³ of capacity to ferment across six sites in the EU, U.S. and Asia

  • Flexible downstream processing pilot plant in Slovakia

  • 30 years of expertise in microbial fermentation and biocatalytic technologies

  • Holistic strategies for process development and strain development

  • More than 25 commercial products based on fermenting processes

  • Broad expertise across pharma, advanced food ingredients and nature-identical materials

Biocatalysis
Evonik Health Care API Contract Manufacturing Capabilities: Biocatalysis

Full service from screening to biocatalyst supply and large-scale production:

  • Enzymatic chemistry with more than 20 different enzymes applied at production scale

  • A strong record in developing new enzyme platforms (bacteria, algae, fungi)

  • More than 40 years of biotechnology expertise

  • A range of process development options beyond large-scale enzyme supply

  • Development and scale-up of biocatalytic processes

Catalysis
Evonik Health Care API Contract Manufacturing Capabilities: Catalysis

Full service from catalyst development to scale-up and production:

  • A large portfolio of heterogeneous and homogeneous catalysts

  • More than 20 years of catalytic process development expertise

  • More than 30 years of expertise in the development of commercialization of catalysts for organic reactions

  • Five global sites for catalytic reactions: Up to 25 bar; 80 °C – 200 °C; 100 – 16,000 liters; glass lined, steel or Hastelloy; with HPAPI options availab

Chiral chemistry
Evonik Health Care API Contract Manufacturing Capabilities: Chiral Chemistry

Decades of expertise in asymmetric synthesis and chiral resolution:

  • A full portfolio from chiral pool synthesis to chemo-catalysis and biocatalysis

  • Established production of more than 100 chiral products including various amino acids

  • A technology toolbox for chiral compounds including heterogeneous chemistry

  • Homogeneous catalysts, reductive animation, and hydrazine reduction

Cryogenic chemistry
Evonik Health Care API Contract Manufacturing Capabilities: Cryogenic Chemistry

The world’s largest cGMP capacity for cryogenic reactions:

  • A total capacity of more than 200 m³ across four different sites, reactions down to – 80 °C

  • Reactors from 500 liters to 8 m³ (glass lined and Hastelloy), up to 10 bar

  • 50 reactors with cryogenic capacities (batch or continuous processing)

  • Organometallic reactions available at three sites globally

Technological capabilities
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Complementary media
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