Therapeutic proteins, whether naturally derived or genetically engineered for maximal efficacy and safety, have either cured, or allowed patients with chronic diseases to lead long, healthier lives. From insulins, to clotting factors to monoclonal antibodies and many more, proteins are front line therapeutics for a wide range of conditions. USP offers the analytical procedures, bioassays and highly characterized physical reference standards and materials manufacturers need to produce these high impact therapeutics with high quality and confidence.
NEW! Host Cell Proteins (HCPs)
Demonstrating clearance of HCPs is required for mAbs and protein therapies. USP now supports HCP analysis by mass spectrometry with our new Recombinant CHO PLBL2 protein. This well characterized material can be used as a standard or control in PLBL2 ELISA or mass spectrometry-based workflows to monitor the clearance of this HCO from your therapeutic product. HCP by MS is supported by <1132.1> Residual Host Cell Protein measurement in Biopharmaceuticals by Mass Spectrometry", in PF 49(3).
NEW! USP Bioassay Reference Standards
Enabling consistent potency measurement with bioassay reference standards
The USP Albumin Human Protein family includes:
- USP Monograph: Albumin Human
- Reference Standard: Albumin Human - NEW!
- USP Monograph: Recombinant Albumin Human
- Reference Standard: Recombinant Human Albumin Reference Standard
- Excipients
- Sodium Caprylate
- Please note: This list is not exhaustive and there could be other excipients used. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Alteplase Protein family includes:
- USP Monographs: Alteplase, Alteplase for Injection
- Excipients
- Arginine
- Phosphoric Acid Reference Standard
- Polysorbate 80 Reference Standard
- Water
- Please note: This list is not exhaustive and there could be other excipients used. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Antithrombin III Human Protein family includes:
- USP Monograph: Antithrombin III Human
- Reference Standards:
- Antithrombin III Human Reference Standard
- Heparin Sodium for Assays Reference Standard
- Excipients
- Alanine
- Albumin Human Reference Standard
- Caprylic Acid Reference Standard
- Mannitol Reference Standard
- N-Acetyl-Dl-Tryptophan
- Sodium Chloride Reference Standard
- Trisodium Citrate Dihydrate
- Water
- Please note: This list is not exhaustive and there could be other excipients used. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Chorionic Gonadotropin Protein family includes:
- USP Monographs:
- Reference Standard: Human Chorionic Gonadotropin Reference Standard
- Excipients
- Benzyl Alcohol Reference Standard
- Croscarmellose Sodium Reference Standard
- Mannitol Reference Standard
- Phosphoric Acid Reference Standard
- Sodium Chloride Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Coagulation Factors Protein family includes:
- USP General Chapter:
- <1035> Potency Assays to Evaluate Coagulation Factor VIII and Factor IX (not yet official; Commenting Closed 31-May-2023; in PF49(2))
- Reference Standards:
- Coagulation Factor VIIa Reference Standard
- Coagulation Factor VIIa for Bioassay Reference Standard - NEW!
- Application Note:
The USP Collagenase Protein family includes:
- USP General Chapter:
- Collagenase I
- USP General Chapter: <89.1> Collagenase I
- USP Monograph: Collagenase I
- Reference Standards:
- Collagenase I Reference Standard
- Collagenase II Reference Standard
- Collagenase II
- USP General Chapter: <89.2> Collagenase II
- USP Monograph: Collagenase II
- API: Collagenase II Reference Standard
The USP Epoetin Protein family includes:
- USP General Chapter: <124> Erythropoietin Bioassays
- Reference Standard: Erythropoietin for Bioassays Reference Standard
- Reference Standard: Erythropoietin Reference Standard
Educational resource: A Reference Standard for Analytical Testing of Erythropoietin
The USP Etanercept Fusion Protein family includes:
- Reference Standards:
- Application Note:
The USP Filgrastim Protein family includes:
- USP Monograph: Filgrastim
- Reference Standards:
- Filgrastim System Suitability Reference Standard
- Filgrastim for Bioassay Reference Standard
- High Molecular Weight Filgrastim Reference Standard
- Pegfilgrastim for Bioassay Reference Standard
- Methoxy Polyethylene Glycol (mPEG) Aldehyde, 20kDa Reference Standard
- Technical Note: USP Methoxy Polyethylene Glycol Aldehyde, 20 kDa Reference Standard
- Excipients
- Polysorbate 20 Reference Standard
- Sorbitol Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Hyaluronidase Protein family includes:
- USP Monographs: Hyaluronidase Injection, Hyaluronidase for Injection
- Reference Standards:
- l-Tyrosine Reference Standard
- Excipients
- Albumin Human Reference Standard
- Hydrochloric Acid
- Methionine
- Polysorbate 80 Reference Standard
- Sodium Chloride Reference Standard
- Sodium Hydroxide
- Sodium Phosphate, Dibasic, Anhydrous
- Please note: This list is not exhaustive and there could be other excipients used. Please visit the USP store to explore our full range of reference standards for excipients.
USP maintains 16 insulin monographs, 7 reference standards, and 2 general chapters. USP quality standards for insulins cover a broad range of requirements.
The USP Interferon Beta-1A Protein family includes:
- Reference Standards:
- Interferon Beta-1A Reference Standard
- Interferon Beta-1A for Bioidentity Reference Standard
- Application Note:
- Excipients
- Arginine Hydrochloride Reference Standard
- Glacial Acetic Acid Reference Standard
- Polysorbate 20 Reference Standard
- Sodium Acetate Trihydrate Reference Standard
- Sodium Chloride Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Interleukin Protein family includes:
- USP General Chapter: <92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing
- Reference Standard: rHuman Interleukin 4
- Excipients
- Mannitol Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used. Please visit the USP store to explore our full range of reference standards for excipients.
The USP Pancreatin Protein family includes:
- USP General Chapter: <1025> Pancreatin
- USP Monographs: Pancreatin, Pancreatin Tablets, Pancrelipase, Pancrelipase Capsules, Pancrelipase Delayed-Release Capsules, Pancrelipase Tablets
- Reference Standards:
- Pancreatin Amylase and Protease Reference Standard
- Pancreatin Lipase Reference Standard
- Bile Salts Reference Standard
- Excipients
- Cetyl Alcohol Reference Standard
- Gelatin Reference Standard
- Hypromellose Phthalate Reference Standard
- Sodium Lauryl Sulfate Reference Standard
- Triethyl Citrate Reference Standard
- Titanium Dioxide Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used. Please visit the USP store to explore our full range of reference standards for excipients.
USP supports the use of PEG (Polyethylene Glycol) linkers for bioconjugation and drug delivery.
Reference Standards
Technical Note: USP Methoxy Polyethylene Glycol Aldehyde, 20 kDa Reference Standard
The USP Serine Protease Protein family includes:
- Chymotrypsin
- USP Monograph: Chymotrypsin
- Reference Standards:
- Chymotrypsin Reference Standard
- Trypsin Bovine Reference Standard
- Trypsin
- USP General Chapter: <89> Enzymes used as ancillary materials in pharmaceutical manufacturing
- Reference Standard: Trypsin Recombinant Porcine Reference Standard
The USP Somatropin Protein family includes:
- USP General Chapter: <126> Somatropin Bioidentity Tests
- USP Monographs: Somatropin, Somatropin for Injection
- Reference Standard: Somatropin Reference Standard
- Excipients
- Mannitol Reference Standard
- Please note: This list is not exhaustive and there could be other excipients used. Please visit the USP store to explore our full range of reference standards for excipients.
Products & Resources
Education
- USP Online courses:
- USP General Chapter 1049.1 Design of Stability Studies for Biotechnology Product Development and Lifecycle Management
- Best Practices for Mass Spectrometry-Based Multi-Attribute Method (MAM) for Therapeutic Proteins USP General Chapter 1060
- Characterization and Biological Relevance of Protein Aggregates and Other Particles 100- 20,000 nm in Size (Sub Micron and Subvisible)
- New Understanding Relating to Existing Excipients and Formulation Approaches
- Analytical Aspects of Control and Characterization: Polysorbate Case Study
- Bioassay Course (Coming Soon!)
- Publications:
- NEW! Quality Standards for Identity, Activity, and Purity Testing of Coagulation Factor VIIa
- NEW! Potency Assessment and Physicochemical Testing of Interferon-β-1a Using USP Reference Standards
- Research paper: A Reference Standard for Analytical Testing of Erythropoietin
- Quality Matters blog: USP standards build trust in biologics and biosimilars
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General Chapters
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Related Products
USP aims to support the complete protein therapy manufacturing process. In addition to Protein-Related Documentary and Reference Standards, we also offer Reference Standards and Materials for:
- Raw material testing
- Impurities and contaminants
- Excipients
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Formulation and Packaging Standards
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