Novozymes Biopharma - Recombinant human albumin, rHAs, cell culture

Novozymes Biopharma

Novozymes Biopharma is a part of Novozymes A/S, the world leader in bioinnovation. Novozymes Biopharma is dedicated to the biopharmaceutical industry. With over 25 years of leadership in biomanufacturing and process development, Novozymes offers regulatory-compliant, dedicated, and proven solutions to optimize your manufacturing process, drug formulation and drug delivery.

Hyaluronic Acid (HA)

Hyaluronic acid (HA) is a polysaccharide (carbohydrate) that occurs naturally in the body. Due to its exceptional water-binding capacity and remarkable visco-elastic properties, HA gives structure to tissue and lubricates joints. Unlike other HA products, HyaCare is produced without the use of animal-derived materials or organic solvents.

HyaCare^®

A high quality ingredient for the medical device and pharmaceutical industries
An innovative form of hyaluronic acid (HA), a biopolymer produced by fermenting the safe bacterial strain, Bacillus subtilis. HyaCare is the first HA in the world produced without the use of animal-derived materials and organic-solvents – a process so revolutionary, it has been patented.

Key benefits

• Safety and purity
• Batch-to-batch consistency
• Superior heat stability and faster dissolution time
• Unique and customized solutions
• Secure supply from a large-scale facility
• cGMP, Q7 validated process

Application areas

• Drug delivery
• Drug formulation
• Medical devices

Albumin fusion technology

Our proprietary technology provides molecular fusion of albumin to protein drug candidates for improved half-life and bioavailability. Albumin fusion technology is a natural alternative to PEGylation.

Combine albufuse with our yeast expression technology and cGMP/Q7-manufacturing services to maximize the benefits of working with us.

Key benefits

• Increased half-life of the active molecule, resulting in:
  • Less frequent administration
  • Increased bioavailability therefore lowered dosage
• Fewer side effects with improved tolerance
• Competitive production costs
• Specific albumin fusion binding matrices available for improved downstream purification
• Animal-free
• Genetically fused.

Application areas

• Protein drug half-life extension and delivery technologies
• Protein expression.

Recombinant albumin

Recombinant albumins ideal for a range of applications

Our animal-free, recombinant albumin (rAlbumin) range enables our biopharmaceutical and medical device customers to deliver safe and affordable product improvements in a variety of applications.

albucult® rAlbumin human USP-NF* For drug, vaccine and device manufacturing use.

CellPrime® rAlbumin AF Available in two grades. For industrial (AF-G) and specialized (AF-S) cell culture applications. Distributed exclusively through our alliance partner Millipore Corporation.

Recombumin® rAlbumin human USP-NF*. For drug and vaccine manufacturing.

Yeast Based Expression Technology

The gold standard in microbial protein expression.

A S. cerevisiae-based expression system is the proven choice for high-yielding, animal-free protein production and provides the perfect vehicle for stable, high-yielding secretion of scFv antibody fragments.

Our in-house technical capabilities include integrated teams responsible for:

• Yeast strain development
• Protein engineering
• Analytical techniques

Key benefits

• Reliable expression platform to produce multiple molecule entities
• Rapid feasibility and optimization studies
• Validation at large-scale
• Safe and stable system

Application areas

• Protein expression e.g. antibody fragment expression
• Clinical and industrial scale biomanufacturing which incorporates our technologies.

Protein A binds proteins from many mammalian species, in particular it binds with high affinity to the Fc region of IgG's. When immobilized on a matrix, e.g; Sepharose, Protein A can be used to isolate IgG from crude protein mixtures.

We have been in the business of producing Protein A for purification applications for over 16 years. At our recently expanded facility in Lund, Sweden, we manufacture kilogram quantities of high quality product every year. Our Protein A product meets the strictest demands of our customers in terms of purity, reproducibility, binding capacity, specificity and other key measures critical to the quality of their downstream processes, allowing them to produce important innovative biopharmaceutical drugs.

Product specifications and features

• Reliable performance: Fc specific binding to IgG
• Guaranteed purity: > 95% purity by SEC
• Activity: > 95% IgG-binding activity
• NOT purified by hIgG affinity
• Produced according to cGMP

A highly potent and effective cGMP alternative to recombinant insulin for cell culture applications. LONG^®R³IGF-I has been specifically engineered for serum-free cell culture supplementation, to improve process efficiency without compromising on safety or compliance.

Used in the manufacture of several FDA, EMEA and Japanese FDA products with more in late-phase clinical trials.

• Increased cell density, higher viability and extended culture duration
• Available as lyophilized powder or ready-to-use liquid formulation
• Animal-free and regulatory-compliant
• Consistent quality and performance
• Secure supply.

• Industrial scale biomanufacturing.

Developed as an iron supplement for cell culture, CellPrime rTransferrin AF is a recombinant analog of human holo-transferrin specifically engineered to provide an animal-free alternative to current serum-derived human or bovine transferrin. Expressed in our proprietary S. cerevisiae system under animal-free conditions, CellPrime rTransferrin AF offers unprecedented benefits over current plasma-derived and chemical alternatives. CellPrime rTransferrin AF is suitable for both research scale mammalian cell culture and industrial scale biomanufacturing.

Key benefits

• Increases cell viability and protein production
• Outperforms plasma-derived transferrin and iron salts across multiple cell lines
• Regulatory-compliant, animal-free
• Manufactured exclusively for cell culture
• GMP for consistent quality.

Application areas

• Research and industrial scale biomanufacturing.

Distributed exclusively through our alliance partner Millipore Corporation.