Formulation of Biomolecules

Process Chemicals and Excipients for the Formulation of Biomolecules

Protein A Affinity  Chromatography   Virus Inactivation   Cation-exchange Chromatography   Anion-exchange Chromatography   Ultrafiltration/
Diafiltration
  Final Formulation

Formulation with the process in mind
Chemicals play an important role in the stabilization of a biologic drug during its manufacturing and formulation process – for instance, by preventing aggregation. We offer a wide range of high-quality stabilizers, buffers and salts to successfully formulate your biomolecules.

Specifically developed for high-risk applications, our buffers, salts and stabilizer are low in bioburden and endotoxins. They are supported by our Emprove® Program and come with extensive documentation, helping you minimize regulatory and quality-associated risks in your biopharmaceutical manufacturing.

Benefit from:

  • Reliable product quality
  • Low microbial and endotoxin load
  • Emprove® Program supporting risk assessment
  • Elemental Impurity Information according to ICH Q3D
  • Paperfree packaging

Learn more:

Exemplary Bioprocess

Virus Inactivation

Buffers

Citrates  
137042 TRI-SODIUM CITRATE DIHYDRAT.  CRYST.  EMPROVE® bio Ph Eur,BP,JP,USP,ACS 
137003 Citric acid monohydrate  EMPROVE® bio Ph Eur,BP,JP,USP,ACS     
137002 Citric acid anhydrous powder EMPROVE® EXPERT Ph Eur,BP,JP,USP,ACS     
Acetates  
137012 Sodium acetate trihydrate suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,USP 
137046 Sodium acetate anhydrous suitable for the biopharmaceutical production EMPROVE® bio USP

Salts

101816 Ammonium sulfate suitable for the biopharmaceutical production EMPROVE® bio ACS,NF

Solvent Detergent

108643 Triton® X-100 suitable for the biopharmaceutical production EMPROVE® bio Ph Eur          
817061 Tween® 80 (Polysorbate) EMPROVE® ESSENTIAL Ph Eur,JP,NF       

Chromatography

Buffers

Tris
108386 Tris(hydroxymethyl)aminomethane (Trometamol) EMPROVE® ESSENTIAL Ph Eur,BP,JPC,USP   
108307 Tris(Hydroxymethyl)aminomethane (Trometamol) high purity EMPROVE® EXPERT Ph Eur,BP,JPC,USP,ACS 
108219 Tris(hydroxymethyl)aminomethane hydrochloride suitable for biopharmaceutical production EMPROVE® bio  
Acetates
137012 Sodium acetate trihydrate suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,USP
137046 Sodium acetate anhydrous suitable for the biopharmaceutical production EMPROVE® bio USP    
100056 Acetic acid (glacial) 100% EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP,E 260
Citrates
137042 TRI-SODIUM CITRATE DIHYDRAT.  CRYST.  EMPROVE® bio Ph Eur,BP,JP,USP,ACS       
137003 Citric acid monohydrate  EMPROVE® bio Ph Eur,BP,JP,USP,ACS  
137002 Citric acid anhydrous powder EMPROVE® EXPERT Ph Eur,BP,JP,USP,ACS   

Salts

137017 Sodium chloride suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,USP
101816 Ammonium sulfate suitable for the biopharmaceutical production EMPROVE® bio ACS,NF     

Stablilizer

101544 L-Arginine monohydrochloride suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,USP 
101587 L-Arginine suitable for use as excipient EMPROVE® exp Ph Eur,JP,USP
100590 GLYCINE CRYST. SUITABLE FOR USE AS EXCIPIENT EMPROVE® EXP PH.EUR.,BP,JP,USP
104352 L-Histidine suitable for use as excipient EMPROVE® exp Ph Eur,USP,JP  
104354 L-Histidine monohydrochloride monohydrate suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP

Ultrafiltration/Formulation

Buffers

Acetates
137012 Sodium acetate trihydrate suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,USP
137046 Sodium acetate anhydrous suitable for the biopharmaceutical production EMPROVE® bio USP  
Citrates
137042 TRI-SODIUM CITRATE DIHYDRAT.  CRYST.  EMPROVE® bio Ph Eur,BP,JP,USP,ACS    
137003 Citric acid monohydrate  EMPROVE® bio Ph Eur,BP,JP,USP,ACS
137002 Citric acid anhydrous powder EMPROVE® EXPERT Ph Eur,BP,JP,USP,ACS       
Amino acid
104352 L-Histidine suitable for use as excipient EMPROVE® exp Ph Eur,USP,JP
104354 L-Histidine monohydrochloride monohydrate suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP
Phosphates
137018 Sodium dihydrogen phosphate dihydrate  EMPROVE® bio Ph Eur,BP,USP,JPE
137036 di-Sodium hydrogen phosphate dihydrate  EMPROVE® bio Ph Eur,BP,USP    
137010 di-Potassium hydrogen phosphate  EMPROVE® bio Ph Eur,BP,USP
137039 Potassium dihydrogen phosphate  EMPROVE® bio Ph Eur,BP,JPC,NF

Stabilizer

137096 D(-)-Mannitol EMPROVE® EXPERT Ph Eur,BP,USP,JP
100892 Sucrose low in endotoxins suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,NF
104352 L-Histidine suitable for use as excipient EMPROVE® exp Ph Eur,USP,JP    
104354 L-Histidine monohydrochloride monohydrate suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP
100590 GLYCINE CRYST. SUITABLE FOR USE AS EXCIPIENT EMPROVE® EXP PH.EUR.,BP,JP,USP
101587 L-Arginine suitable for use as excipient EMPROVE® exp Ph Eur,JP,USP
101544 L-Arginine monohydrochloride suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,USP  
111597 Parteck® SI 400 LEX (Sorbitol) suitable for use as excipient EMPROVE® exp Ph Eur,BP,NF,JP

Salts

137017 Sodium chloride suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,USP
101816 Ammonium sulfate suitable for the biopharmaceutical production EMPROVE® bio ACS,NF