Protein Delivery

We collaborate with you to provide tailored excipient solutions, drawing on our expertise and product portfolio to speed up formulation development and time to market. Enabling drug delivery through a wide range of highly purified excipients to improve protein formulation stability.

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Your Protein Delivery partner

With decades of experience in protein delivery, our experts have designed our Super Refined™ range of high purity excipients to ensure optimal protein stabilisation for enhanced biologic drug delivery.

Addressing challenges associated with protein-based therapies

Our experts have designed our high purity and Super Refined™ ranges to enable drug delivery through improving protein and formulation stability and address bioprocessing challenges with high purity ancillary materials.

With our range of highly purified excipients, we empower biologics delivery through innovation, formulation, and application.

Your partner of choice for Protein Delivery and high purity excipients

We offer a wide range of high purity excipients, services and solutions, aiding you in the manufacture of:

Antibodies (for example, fragments and conjugates)
Blood proteins
Cytokines
Enzymes
Hormones

Offering you safety and assurance with high purity products.

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Super Refined™ Poloxamer 188

Super Refined™ Poloxamer 188 is added to mammalian cell culture media to protect cells from shear stress caused by agitation in a bioreactor.

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Solutions for bioprocessing

We leverage our expertise in biotechnology to provide cutting-edge solutions for the bioprocessing of protein-based therapies, including monoclonal antibodies and other recombinant proteins. With our vast portfolio of high purity chemicals, we provide bioprocessing solutions that enable efficient and effective production of biologic drugs.

Our offerings in bioprocessing include chemicals for viral inactivation and cell lysis, meeting the needs of applications such as the biomanufacturing of plasma-derived or blood fractionation therapies, recombinant protein therapeutics, viral vector-based therapies, and more. With our commitment to providing high-performance chemicals, we ensure that you receive innovative and reliable solutions that enhance your biomanufacturing operations at every step of the way. We also pride ourselves in being a regulatory resource to our customers, offering guidance and support to ensure compliance with the latest regulatory requirements.

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Excipients for protein therapeutic formulations

We understand the challenges faced by protein therapy manufacturers in developing formulations that maintain their stability and efficacy, such as protein aggregation. We develop high-quality excipients specifically designed to improve the stability, solubility and bioavailability of protein therapeutics. Our Super Refined™ excipients are manufactured to the highest standards of purity and quality, and undergo rigorous testing to ensure they meet the strict regulatory requirements expected for the parenteral administration route.

We offer a comprehensive portfolio of excipients to support the formulation of protein therapies, including stabilizers, surfactants, solubilizers and preservatives, to help you optimize your formulations and achieve long-term stability and efficacy. Our excipients undergo application testing to ensure their compatibility with a range of protein therapeutics, including monoclonal antibodies. Excipients are an essential component of protein formulations, and we are committed to providing innovative and reliable solutions to support your development and manufacturing needs. Our team of technical experts works closely with you to ensure that our excipients are always optimized for specific formulation requirements. Through our effective products and solutions, we are proud to contribute to the development of life-saving protein therapies that meet the needs of patients around the world.

Super Refined™ excipients for Protein Delivery

Our Super Refined excipients are stripped of a number of oxidative impurities, such as peroxides, aldehydes, and catalyst residues. The removal of these problematic species helps to reduce negative API and excipient interactions, maintaining both the stability of the drug and the final formulation. In addition, the removal of these impurities can minimise cellular irritation, reduce taste impact, and potentially decrease allergenicity.

We have a large variety of products, ranging from various polysorbates, polyethylene glycols (PEG), esters, vegetable oils, and more.

Add significant value to your drug formulations today with our Super Refined range offering:

Minimised API degradation
Reduced oxidation potential
Reduced impurities and allergic potential.

Excipientes Super Refined™

Nuestra línea de excipientes Super Refined™ asegura que sus formulaciones sean estables, efectivas y consistentes.

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Minimised API degradation in protein drug delivery

Our Super Refined™ range can provide enhanced API stability.

A chemotherapy drug (docetaxel) was dissolved in both standard grade compendial and Super Refined™ PEG 400 and aged for 12 weeks at 40oC. The samples were analysed by HLPC at 0, 4, 8 and 12 weeks.

After 12 weeks of accelerated aging the Super Refined™ PEG 400 showed over 90% drug recovery, in comparison to its standard compendial grade counterpart. Our Super Refined™ excipients minimise API degradation, offering you confidence in your formulation and optimising drug delivery. Order your sample today.

Reduced impurities and allergic potential in protein drug delivery

The Super Refining process results in reduced levels of impurities, such as formaldehyde, in our excipients. The presence of high levels of formaldehyde in excipients has been linked to API degradation, drug instability and cell membrane irritation.

When compared to its standard compendial grade counterpart Super Refined™ Polysorbate 80 showed an 81% reduction in formaldehyde levels. The improved patient comfort associated with our Super Refined™ range aligns with Croda’s purpose to use smart science to improve lives, speak to our experts today and learn how our Super Refined™ range can work for you.

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