Host cell protein searchable database

Host cell proteins (HCPs) are process-related impurities that may co-purify with biopharmaceutical drug products. Within this class of impurities there are some that are more problematic. These problematic HCPs can be considered high-risk and can include those that are immunogenic, biologically active, or enzymatically active with the potential to degrade either product molecules or excipients used in formulation.

The “High‐risk” host cell proteins (HCPs): A multi‐company collaborative view publication and database produced by the host cell protein workstream provide a comprehensive review/list of potential problematic HCPs that could impact the safety, efficacy, and quality aspects of CHO-produced biologics, during their development and manufacturing. It is a great reference on the best practice and control strategy for “high-risk” HCPs” in the biopharmaceutical industry.

The database currently focuses on the HCPs specifically isolated from biotherapeutics produced in CHO cells, which are frequently seen HCPs found throughout different processing steps. These HCPs were identified by the BioPhorum’s development group’s Host Cell Protein workstream, through literature review and industry survey data.

The team are continuing to work on compiling characterization data for the HCPs, which includes information such as molecular weight, isoelectric point, accession number, number of amino acids, a hyperlink to the UniProt entry (and a list of references) for each protein.

The key purpose of the database is also to provide information on HCPs that are considered to be problematic and therefore “high-risk.” It further classifies them into four major categories based on their impact to:

  • Product quality
  • Formulation
  • Direct biological function in humans
  • Immunogenicity.

Ultimately, the team hopes to include information on the function of all the listed proteins, the specific type of impact (drug or patient) such as aggregation, fragmentation, modification or immunogenicity and the associated references for each protein. Currently this information is only listed for the “high risk” HCPs within the database (rows are highlighted in RED and this list may be filtered by clicking the high risk HCP box in the search field below). The dynamic list will continue to be updated when new proteins are identified and/or reported in the literature.

If you wish to contribute to the database, learn how you may access the latest database or hear more about how you can join BioPhorum, please contact info@biophorum.com



Identified HCP (Abbreviation) High risk? Mw (kDa) pI UniProt Accession No. No. of amino acids
60S acidic ribosomal protein P0 No 30.6 8.9 G3HKG9 280 Read more
Identified HCP (Abbreviation) 60S acidic ribosomal protein P0
High risk HCP No
MW (kDa) 30.6
pI 8.9
UniProt Accession No. G3HKG9
No. of amino acids 280
40S ribosomal protein SA (RPSA) No 19.7 9.4 G3HQX0 179 Read more
Identified HCP (Abbreviation) 40S ribosomal protein SA (RPSA)
High risk HCP No
MW (kDa) 19.7
pI 9.4
UniProt Accession No. G3HQX0
No. of amino acids 179
Cathepsin Z (CatZ) High Risk 34 7.5 Q9EPP7 306 Read more
Identified HCP (Abbreviation) Cathepsin Z (CatZ)
High risk HCP Yess
MW (kDa) 34
pI 7.5
UniProt Accession No. Q9EPP7
No. of amino acids 306
Function
Impact
Type of impact
Status Brix et al., 2018; Chiverton et al., 2016; Park et al., 2017
Cathepsin L (CatL) High Risk 37.3 6.8 G3INC5 333 Read more
Identified HCP (Abbreviation) Cathepsin L (CatL)
High risk HCP Yess
MW (kDa) 37.3
pI 6.8
UniProt Accession No. G3INC5
No. of amino acids 333
Function
Impact
Type of impact
Status Gao et al., 2011; Luo et al., 2018; Park et al., 2017
Cathepsin E (CatE) No 42.2 4.7 G3HAY9 388 Read more
Identified HCP (Abbreviation) Cathepsin E (CatE)
High risk HCP No
MW (kDa) 42.2
pI 4.7
UniProt Accession No. G3HAY9
No. of amino acids 388
Cathepsin D (CatD) No 44.1 6.5 G3I4W7 408 Read more
Identified HCP (Abbreviation) Cathepsin D (CatD)
High risk HCP No
MW (kDa) 44.1
pI 6.5
UniProt Accession No. G3I4W7
No. of amino acids 408
Cathepsin B (CatB) High Risk 37.5 5.7 G3H0L9 339 Read more
Identified HCP (Abbreviation) Cathepsin B (CatB)
High risk HCP Yess
MW (kDa) 37.5
pI 5.7
UniProt Accession No. G3H0L9
No. of amino acids 339
Function
Impact
Type of impact
Status Aboulaich et al., 2014; Albrecht et al., 2018b; Levy et al., 2016; Migani et al., 2017; Gao et al., 2011; Yang et al., 2019; Zhang et al., 2016; Zhang et al., 2019
Catalase No 63.1 8.3 G3GYY6 555 Read more
Identified HCP (Abbreviation) Catalase
High risk HCP No
MW (kDa) 63.1
pI 8.3
UniProt Accession No. G3GYY6
No. of amino acids 555
Carboxypeptidase D (Cpd) High Risk 123.4 5.8 G3HR95 1106 Read more
Identified HCP (Abbreviation) Carboxypeptidase D (Cpd)
High risk HCP Yess
MW (kDa) 123.4
pI 5.8
UniProt Accession No. G3HR95
No. of amino acids 1106
Function
Impact
Type of impact
Status Hu et al., 2016; Dick et al., 2008 (Dick, Qiu, Mahon, Adamo, & Cheng, 2008)
Carboxylesterase B-1-like protein, Liver (CES-B1L) No 77.9 7.9 A0A061I7X9 704 Read more
Identified HCP (Abbreviation) Carboxylesterase B-1-like protein, Liver (CES-B1L)
High risk HCP No
MW (kDa) 77.9
pI 7.9
UniProt Accession No. A0A061I7X9
No. of amino acids 704
Carboxylesterase 1-like protein, Liver (CES1) High Risk 97.5 5.9 A0A061IFE2 882 Read more
Identified HCP (Abbreviation) Carboxylesterase 1-like protein, Liver (CES1)
High risk HCP Yess
MW (kDa) 97.5
pI 5.9
UniProt Accession No. A0A061IFE2
No. of amino acids 882
Function
Impact
Type of impact
Status Zhang et al., 2020
Calmodulin (CaM) No 16.7 4.1 A0A061HUH1 149 Read more
Identified HCP (Abbreviation) Calmodulin (CaM)
High risk HCP No
MW (kDa) 16.7
pI 4.1
UniProt Accession No. A0A061HUH1
No. of amino acids 149
C-X-C motif chemokine 3 (CXCL3) High Risk 11 9.1 A4URF0 101 Read more
Identified HCP (Abbreviation) C-X-C motif chemokine 3 (CXCL3)
High risk HCP Yess
MW (kDa) 11
pI 9.1
UniProt Accession No. A4URF0
No. of amino acids 101
Function
Impact
Type of impact
Status Farrell et al., 2015; Gilgunn & Bones, 2018; Zhang et al., 2014
C-C motif chemokine No 15.9 9.3 G3GTT2 143 Read more
Identified HCP (Abbreviation) C-C motif chemokine
High risk HCP No
MW (kDa) 15.9
pI 9.3
UniProt Accession No. G3GTT2
No. of amino acids 143
Annexin A5 No 36.1 4.9 G3I5A4 321 Read more
Identified HCP (Abbreviation) Annexin A5
High risk HCP No
MW (kDa) 36.1
pI 4.9
UniProt Accession No. G3I5A4
No. of amino acids 321
Annexin A2 No 27 5.7 G3IG05 244 Read more
Identified HCP (Abbreviation) Annexin A2
High risk HCP No
MW (kDa) 27
pI 5.7
UniProt Accession No. G3IG05
No. of amino acids 244
Alpha-enolase (2-phospho-D-glycerate hydro-lyase) High Risk 15.5 5 G3I0W1 139 Read more
Identified HCP (Abbreviation) Alpha-enolase (2-phospho-D-glycerate hydro-lyase)
High risk HCP Yess
MW (kDa) 15.5
pI 5
UniProt Accession No. G3I0W1
No. of amino acids 139
Function
Impact
Type of impact
Status Liu et al., 2019
Actin, cytoplasmic 1 (ACTB) No 41.7 5.2 P48975 375 Read more
Identified HCP (Abbreviation) Actin, cytoplasmic 1 (ACTB)
High risk HCP No
MW (kDa) 41.7
pI 5.2
UniProt Accession No. P48975
No. of amino acids 375
78 kDa glucose regulated protein(GRP78, BiP) High Risk 72.4 5.1 G3I8R9 654 Read more
Identified HCP (Abbreviation) 78 kDa glucose regulated protein(GRP78, BiP)
High risk HCP Yess
MW (kDa) 72.4
pI 5.1
UniProt Accession No. G3I8R9
No. of amino acids 654
Function
Impact
Type of impact
Status Aboulaich et al., 2014; Albrecht et al., 2018b; Chiverton et al., 2016; Falkenberg et al., 2019; Kreimer et al., 2017; Liu et al., 2019; Migani et al., 2017; Zhang et al., 2014; Joucla et al., 2013; Levy et al., 2016
Calreticulin (CALR) No 48.4 4.3 G3HCX8 417 Read more
Identified HCP (Abbreviation) Calreticulin (CALR)
High risk HCP No
MW (kDa) 48.4
pI 4.3
UniProt Accession No. G3HCX8
No. of amino acids 417
Galectin-3 (Gal-3) No 32.4 6.9 G3H7B3 281 Read more
Identified HCP (Abbreviation) Galectin-3 (Gal-3)
High risk HCP No
MW (kDa) 32.4
pI 6.9
UniProt Accession No. G3H7B3
No. of amino acids 281
Glutathione S-transferase P 1 (GSTP1) High Risk 25 8.2 G3I3Y6 221 Read more
Identified HCP (Abbreviation) Glutathione S-transferase P 1 (GSTP1)
High risk HCP Yess
MW (kDa) 25
pI 8.2
UniProt Accession No. G3I3Y6
No. of amino acids 221
Function
Impact
Type of impact
Status Aboulaich et al., 2014; Gilgunn & Bones, 2018; Zhang et al., 2014; Albrecht et al., 2018b
Glyceraldehyde-3-phosphate dehydrogenase (G3P) No 35.7 8.5 P17244 333 Read more
Identified HCP (Abbreviation) Glyceraldehyde-3-phosphate dehydrogenase (G3P)
High risk HCP No
MW (kDa) 35.7
pI 8.5
UniProt Accession No. P17244
No. of amino acids 333
Granulins (GRN) No 63.9 6 G3HLK3 592 Read more
Identified HCP (Abbreviation) Granulins (GRN)
High risk HCP No
MW (kDa) 63.9
pI 6
UniProt Accession No. G3HLK3
No. of amino acids 592
GTP-binding nuclear protein (RAN) No 24.5 8.4 G3IHE5 216 Read more
Identified HCP (Abbreviation) GTP-binding nuclear protein (RAN)
High risk HCP No
MW (kDa) 24.5
pI 8.4
UniProt Accession No. G3IHE5
No. of amino acids 216
Guanine nucleotide-binding protein beta-2-like 1 (RACK1) No 30.4 7 G3HK00 276 Read more
Identified HCP (Abbreviation) Guanine nucleotide-binding protein beta-2-like 1 (RACK1)
High risk HCP No
MW (kDa) 30.4
pI 7
UniProt Accession No. G3HK00
No. of amino acids 276
Heat shock cognate 71 kDa protein (HSPA8) No 70.8 5.2 P19378 646 Read more
Identified HCP (Abbreviation) Heat shock cognate 71 kDa protein (HSPA8)
High risk HCP No
MW (kDa) 70.8
pI 5.2
UniProt Accession No. P19378
No. of amino acids 646
Heat shock protein HSP 90-alpha (HSP90A) No 84.8 5 P46633 733 Read more
Identified HCP (Abbreviation) Heat shock protein HSP 90-alpha (HSP90A)
High risk HCP No
MW (kDa) 84.8
pI 5
UniProt Accession No. P46633
No. of amino acids 733
Heat shock protein HSP 90-beta (HSP90B) No 47.8 5.3 G3HC84 412 Read more
Identified HCP (Abbreviation) Heat shock protein HSP 90-beta (HSP90B)
High risk HCP No
MW (kDa) 47.8
pI 5.3
UniProt Accession No. G3HC84
No. of amino acids 412
Endoplasmin (HSP90B1) No 92.6 4.7 G3HQM6 803 Read more
Identified HCP (Abbreviation) Endoplasmin (HSP90B1)
High risk HCP No
MW (kDa) 92.6
pI 4.7
UniProt Accession No. G3HQM6
No. of amino acids 803
Galectin 3 binding protein (Gal-3BP) No 63.8 5.1 G3H3E4 574 Read more
Identified HCP (Abbreviation) Galectin 3 binding protein (Gal-3BP)
High risk HCP No
MW (kDa) 63.8
pI 5.1
UniProt Accession No. G3H3E4
No. of amino acids 574
Fructose-bisphosphate aldolase (FBA) No 39.4 8.3 G3I4H6 364 Read more
Identified HCP (Abbreviation) Fructose-bisphosphate aldolase (FBA)
High risk HCP No
MW (kDa) 39.4
pI 8.3
UniProt Accession No. G3I4H6
No. of amino acids 364
Follistatin-related protein 1 (FST1) No 65.4 6.2 G3HAI3 583 Read more
Identified HCP (Abbreviation) Follistatin-related protein 1 (FST1)
High risk HCP No
MW (kDa) 65.4
pI 6.2
UniProt Accession No. G3HAI3
No. of amino acids 583
ERP57 protein No 56.8 6 Q91Z81 505 Read more
Identified HCP (Abbreviation) ERP57 protein
High risk HCP No
MW (kDa) 56.8
pI 6
UniProt Accession No. Q91Z81
No. of amino acids 505
Galectin-1 (Gal-1) No 14.8 5.5 P48538 135 Read more
Identified HCP (Abbreviation) Galectin-1 (Gal-1)
High risk HCP No
MW (kDa) 14.8
pI 5.5
UniProt Accession No. P48538
No. of amino acids 135
Elongation factor 2 (eEF2) No 95.3 6.2 P09445 858 Read more
Identified HCP (Abbreviation) Elongation factor 2 (eEF2)
High risk HCP No
MW (kDa) 95.3
pI 6.2
UniProt Accession No. P09445
No. of amino acids 858
Elongation factor 1-alpha (eEF1a) No 50.1 9.1 P62629 462 Read more
Identified HCP (Abbreviation) Elongation factor 1-alpha (eEF1a)
High risk HCP No
MW (kDa) 50.1
pI 9.1
UniProt Accession No. P62629
No. of amino acids 462
Cofilin-1 (CFL) No 18.5 8.2 G3IDM2 166 Read more
Identified HCP (Abbreviation) Cofilin-1 (CFL)
High risk HCP No
MW (kDa) 18.5
pI 8.2
UniProt Accession No. G3IDM2
No. of amino acids 166
Clusterin (CLU) High Risk 51.8 5.5 G3HNJ3 447 Read more
Identified HCP (Abbreviation) Clusterin (CLU)
High risk HCP Yess
MW (kDa) 51.8
pI 5.5
UniProt Accession No. G3HNJ3
No. of amino acids 447
Function
Impact
Type of impact
Status Aboulaich et al., 2014; Albrecht et al., 2018a; Farrell et al., 2015; Kreimer et al., 2017; Levy et al., 2016; Migani et al., 2017; Singh et al., 2020; Zhang et al., 2014; Doneanu et al., 2012; Levy et al., 2014; Wilson & Easterbrook-Smith, 1992
Chondroitin sulfate proteoglycan 4 (CSPG4) No 252 5.4 G3H0E4 2323 Read more
Identified HCP (Abbreviation) Chondroitin sulfate proteoglycan 4 (CSPG4)
High risk HCP No
MW (kDa) 252
pI 5.4
UniProt Accession No. G3H0E4
No. of amino acids 2323
Lysosomal Acid Lipase (LAL) High Risk 45.6 7.3 G3HQY6 397 Read more
Identified HCP (Abbreviation) Lysosomal Acid Lipase (LAL)
High risk HCP Yess
MW (kDa) 45.6
pI 7.3
UniProt Accession No. G3HQY6
No. of amino acids 397
Function
Impact
Type of impact
Status Levy et al., 2014; McShan et al., 2016; Kreimer et al., 2017; Valente et al., 2015
Lysosomal Phospholipase A2 (LPLA2) No 47.2 6.1 G3HKV9 412 Read more
Identified HCP (Abbreviation) Lysosomal Phospholipase A2 (LPLA2)
High risk HCP No
MW (kDa) 47.2
pI 6.1
UniProt Accession No. G3HKV9
No. of amino acids 412
Lysosomal protective protein (CTSA) No 54.2 5.7 G3H8V5 475 Read more
Identified HCP (Abbreviation) Lysosomal protective protein (CTSA)
High risk HCP No
MW (kDa) 54.2
pI 5.7
UniProt Accession No. G3H8V5
No. of amino acids 475
Malate dehydrogenase, cytoplasmic (MDHC) No 36.5 6.2 G3HDQ2 334 Read more
Identified HCP (Abbreviation) Malate dehydrogenase, cytoplasmic (MDHC)
High risk HCP No
MW (kDa) 36.5
pI 6.2
UniProt Accession No. G3HDQ2
No. of amino acids 334
Matrix metalloproteinase-19 (MMP-19) High Risk 58.9 7.7 G3HRK9 525 Read more
Identified HCP (Abbreviation) Matrix metalloproteinase-19 (MMP-19)
High risk HCP Yess
MW (kDa) 58.9
pI 7.7
UniProt Accession No. G3HRK9
No. of amino acids 525
Function
Impact
Type of impact
Status Aboulaich et al., 2014; Farrell et al., 2015; Gilgunn & Bones, 2018; Levy et al., 2016;
Metalloproteinase inhibitor 1 (TIMP1) No 22.4 8.8 G3IBH0 203 Read more
Identified HCP (Abbreviation) Metalloproteinase inhibitor 1 (TIMP1)
High risk HCP No
MW (kDa) 22.4
pI 8.8
UniProt Accession No. G3IBH0
No. of amino acids 203
Monocyte Chemoattractant Protein-1 (MCP-1) High Risk 15.9 9.3 G3GTT2 143 Read more
Identified HCP (Abbreviation) Monocyte Chemoattractant Protein-1 (MCP-1)
High risk HCP Yess
MW (kDa) 15.9
pI 9.3
UniProt Accession No. G3GTT2
No. of amino acids 143
Function
Impact
Type of impact
Status Leister et al., 2019; Yoshimura & Leonard, 1989
Myosin-9 (MYH9) No 225.8 5.5 G3IH63 1948 Read more
Identified HCP (Abbreviation) Myosin-9 (MYH9)
High risk HCP No
MW (kDa) 225.8
pI 5.5
UniProt Accession No. G3IH63
No. of amino acids 1948
Nidogen-1 (NID1) No 30.1 8.4 G3I3U5 278 Read more
Identified HCP (Abbreviation) Nidogen-1 (NID1)
High risk HCP No
MW (kDa) 30.1
pI 8.4
UniProt Accession No. G3I3U5
No. of amino acids 278
Inter-alpha-trypsin inhibitor heavy chain H5 isoform X2 (ITIH5L) No 107.9 8.5 G3H7S9 983 Read more
Identified HCP (Abbreviation) Inter-alpha-trypsin inhibitor heavy chain H5 isoform X2 (ITIH5L)
High risk HCP No
MW (kDa) 107.9
pI 8.5
UniProt Accession No. G3H7S9
No. of amino acids 983
Legumain (LGMN) No 49.6 6.1 G3I1H5 438 Read more
Identified HCP (Abbreviation) Legumain (LGMN)
High risk HCP No
MW (kDa) 49.6
pI 6.1
UniProt Accession No. G3I1H5
No. of amino acids 438
Laminin subunit gamma-1 (LAMC1) No 172.1 5 G3HG25 1559 Read more
Identified HCP (Abbreviation) Laminin subunit gamma-1 (LAMC1)
High risk HCP No
MW (kDa) 172.1
pI 5
UniProt Accession No. G3HG25
No. of amino acids 1559
Laminin subunit beta-1 (LAMB1) No 178.1 4.8 G3I278 1617 Read more
Identified HCP (Abbreviation) Laminin subunit beta-1 (LAMB1)
High risk HCP No
MW (kDa) 178.1
pI 4.8
UniProt Accession No. G3I278
No. of amino acids 1617
lactotransferrin (LTF) No 71.4 8.6 G3HTA2 648 Read more
Identified HCP (Abbreviation) lactotransferrin (LTF)
High risk HCP No
MW (kDa) 71.4
pI 8.6
UniProt Accession No. G3HTA2
No. of amino acids 648
Lactadherin (MFG-E8) No 16.1 9.5 G3ICD3 140 Read more
Identified HCP (Abbreviation) Lactadherin (MFG-E8)
High risk HCP No
MW (kDa) 16.1
pI 9.5
UniProt Accession No. G3ICD3
No. of amino acids 140
L-lactate dehydrogenase A chain (LDHA) No 36.5 7 Q06BU8 332 Read more
Identified HCP (Abbreviation) L-lactate dehydrogenase A chain (LDHA)
High risk HCP No
MW (kDa) 36.5
pI 7
UniProt Accession No. Q06BU8
No. of amino acids 332
Histone H2B Type 1-N (H2B1N) No 13.9 10.3 G3HDU3 126 Read more
Identified HCP (Abbreviation) Histone H2B Type 1-N (H2B1N)
High risk HCP No
MW (kDa) 13.9
pI 10.3
UniProt Accession No. G3HDU3
No. of amino acids 126
Histone H2A No 26.7 10.9 G3HDS3 236 Read more
Identified HCP (Abbreviation) Histone H2A
High risk HCP No
MW (kDa) 26.7
pI 10.9
UniProt Accession No. G3HDS3
No. of amino acids 236
Hexosaminidase, beta No 60.7 6 G3H3P 528 Read more
Identified HCP (Abbreviation) Hexosaminidase, beta
High risk HCP No
MW (kDa) 60.7
pI 6
UniProt Accession No. G3H3P
No. of amino acids 528
Lipoprotein Lipase (LPL) High Risk 50.5 8 G3H6V7 450 Read more
Identified HCP (Abbreviation) Lipoprotein Lipase (LPL)
High risk HCP Yess
MW (kDa) 50.5
pI 8
UniProt Accession No. G3H6V7
No. of amino acids 450
Function
Impact
Type of impact
Status Chiu et al., 2017; Levy et al., 2014; McShan et al., 2016; Levy et al., 2016; Singh et al., 2020
Procollagen-lysine 2-oxoglutarate 5-deoxygenase_1 (PLOD1) High Risk 76 5.8 G3IIE7 659 Read more
Identified HCP (Abbreviation) Procollagen-lysine 2-oxoglutarate 5-deoxygenase_1 (PLOD1)
High risk HCP Yess
MW (kDa) 76
pI 5.8
UniProt Accession No. G3IIE7
No. of amino acids 659
Function
Impact
Type of impact
Status Hogwood et al., 2016; Jawa et al., 2016
Phospholipid transfer protein (PLTP) No 54.4 6.2 G3H8V4 493 Read more
Identified HCP (Abbreviation) Phospholipid transfer protein (PLTP)
High risk HCP No
MW (kDa) 54.4
pI 6.2
UniProt Accession No. G3H8V4
No. of amino acids 493
Proteasome subunit alpha type-7 (PSA7) No 23.8 8.6 G3GWR8 212 Read more
Identified HCP (Abbreviation) Proteasome subunit alpha type-7 (PSA7)
High risk HCP No
MW (kDa) 23.8
pI 8.6
UniProt Accession No. G3GWR8
No. of amino acids 212
Protein S100-A6 (S10A6) High Risk 10 5.3 G3HC31 89 Read more
Identified HCP (Abbreviation) Protein S100-A6 (S10A6)
High risk HCP Yess
MW (kDa) 10
pI 5.3
UniProt Accession No. G3HC31
No. of amino acids 89
Function
Impact
Type of impact
Status Aboulaich et al., 2014; Gilgunn & Bones, 2018; Paintlia et al., 2004
Pyruvate Kinase (PK) High Risk 51.6 7.6 G3H3Q1 472 Read more
Identified HCP (Abbreviation) Pyruvate Kinase (PK)
High risk HCP Yess
MW (kDa) 51.6
pI 7.6
UniProt Accession No. G3H3Q1
No. of amino acids 472
Function
Impact
Type of impact
Status Chiverton et al., 2016; Goey et al., 2018; Zhang et al., 2014
Serine protease (HTRA1) High Risk 28.7 6.5 G3IBF4 268 Read more
Identified HCP (Abbreviation) Serine protease (HTRA1)
High risk HCP Yess
MW (kDa) 28.7
pI 6.5
UniProt Accession No. G3IBF4
No. of amino acids 268
Function
Impact
Type of impact
Status Aboulaich et al., 2014; Dorai et al., 2011; Falkenberg et al., 2019; Gilgunn & Bones, 2018; Goey et al., 2018; Zhang et al., 2014
Sialate o-acetylesterase (SIAE) High Risk 59.3 8.6 A0A3L7HS03 529 Read more
Identified HCP (Abbreviation) Sialate o-acetylesterase (SIAE)
High risk HCP Yess
MW (kDa) 59.3
pI 8.6
UniProt Accession No. A0A3L7HS03
No. of amino acids 529
Function
Impact
Type of impact
Status
Sulfated glycoprotein (SGP-1) No 27.4 5.4 G3I1Y9 249 Read more
Identified HCP (Abbreviation) Sulfated glycoprotein (SGP-1)
High risk HCP No
MW (kDa) 27.4
pI 5.4
UniProt Accession No. G3I1Y9
No. of amino acids 249
Transforming Growth Factor-b1 (TGF-b1) High Risk 26.4 8.5 G3IA12 237 Read more
Identified HCP (Abbreviation) Transforming Growth Factor-b1 (TGF-b1)
High risk HCP Yess
MW (kDa) 26.4
pI 8.5
UniProt Accession No. G3IA12
No. of amino acids 237
Function
Impact
Type of impact
Status Beatson et al., 2011; Vanderlaan et al., 2018
Transgelin-2 (TAGLN) No 22.5 8.8 G3H7Z2 199 Read more
Identified HCP (Abbreviation) Transgelin-2 (TAGLN)
High risk HCP No
MW (kDa) 22.5
pI 8.8
UniProt Accession No. G3H7Z2
No. of amino acids 199
Procollagen C-endopeptidase enhancer (PCPE1) No 55.2 8.5 G3I664 509 Read more
Identified HCP (Abbreviation) Procollagen C-endopeptidase enhancer (PCPE1)
High risk HCP No
MW (kDa) 55.2
pI 8.5
UniProt Accession No. G3I664
No. of amino acids 509
Plectin-1 (Plec1) No 83.4 8.7 G3HWJ2 720 Read more
Identified HCP (Abbreviation) Plectin-1 (Plec1)
High risk HCP No
MW (kDa) 83.4
pI 8.7
UniProt Accession No. G3HWJ2
No. of amino acids 720
Phospholipase D3 (PLD3) No 54.4 6 G3HNQ5 488 Read more
Identified HCP (Abbreviation) Phospholipase D3 (PLD3)
High risk HCP No
MW (kDa) 54.4
pI 6
UniProt Accession No. G3HNQ5
No. of amino acids 488
Phospholipase B-like 2 (PLBL2) High Risk 65.5 5.9 G3I6T1 585 Read more
Identified HCP (Abbreviation) Phospholipase B-like 2 (PLBL2)
High risk HCP Yess
MW (kDa) 65.5
pI 5.9
UniProt Accession No. G3I6T1
No. of amino acids 585
Function
Impact
Type of impact
Status Aboulaich et al., 2014; de Zafra et al., 2015; Fischer et al., 2017; Jawa et al., 2016; Migani et al., 2017
Phosphoglycerate mutase 1 (Pgam1) No 20.2 7.8 G3GZW8 178 Read more
Identified HCP (Abbreviation) Phosphoglycerate mutase 1 (Pgam1)
High risk HCP No
MW (kDa) 20.2
pI 7.8
UniProt Accession No. G3GZW8
No. of amino acids 178
Phosphoglycerate kinase (PGK1) No 44.6 8 P50310 417 Read more
Identified HCP (Abbreviation) Phosphoglycerate kinase (PGK1)
High risk HCP No
MW (kDa) 44.6
pI 8
UniProt Accession No. P50310
No. of amino acids 417
Peroxiredoxin-1 (PRDX1) High Risk 22.3 8.2 Q9JKY1 199 Read more
Identified HCP (Abbreviation) Peroxiredoxin-1 (PRDX1)
High risk HCP Yess
MW (kDa) 22.3
pI 8.2
UniProt Accession No. Q9JKY1
No. of amino acids 199
Function
Impact
Type of impact
Status Aboulaich et al., 2014; Albrecht et al., 2018b; Chiverton et al., 2016; Falkenberg et al., 2019; Jawa et al., 2016; Kreimer et al., 2017; Liu et al., 2019; Migani et al., 2017, Zhang et al., 2014
Peptidyl-prolyl cis-trans isomerase A (PPIA) No 17.9 8.4 P14851 164 Read more
Identified HCP (Abbreviation) Peptidyl-prolyl cis-trans isomerase A (PPIA)
High risk HCP No
MW (kDa) 17.9
pI 8.4
UniProt Accession No. P14851
No. of amino acids 164
Nucleoside diphosphate kinase B (NDPK-B) No 17.3 7.8 G3HBD3 152 Read more
Identified HCP (Abbreviation) Nucleoside diphosphate kinase B (NDPK-B)
High risk HCP No
MW (kDa) 17.3
pI 7.8
UniProt Accession No. G3HBD3
No. of amino acids 152
Nucleobindin-2 (NUCB2) No 50.3 5.1 G3IF52 420 Read more
Identified HCP (Abbreviation) Nucleobindin-2 (NUCB2)
High risk HCP No
MW (kDa) 50.3
pI 5.1
UniProt Accession No. G3IF52
No. of amino acids 420
Transketolase (TKTase) No 67.7 7.6 G3GUU5  623 Read more
Identified HCP (Abbreviation) Transketolase (TKTase)
High risk HCP No
MW (kDa) 67.7
pI 7.6
UniProt Accession No. G3GUU5 
No. of amino acids 623
Triosephosphate isomerase (TPI) No 16.4 8.5 G3HNV4 150 Read more
Identified HCP (Abbreviation) Triosephosphate isomerase (TPI)
High risk HCP No
MW (kDa) 16.4
pI 8.5
UniProt Accession No. G3HNV4
No. of amino acids 150
Tubulin alpha-1A chain (TBA1A) No 50.1 4.9 P68362 451 Read more
Identified HCP (Abbreviation) Tubulin alpha-1A chain (TBA1A)
High risk HCP No
MW (kDa) 50.1
pI 4.9
UniProt Accession No. P68362
No. of amino acids 451
Tubulin alpha-1C chain (TBA1C) No 49.9 5 P68365 449 Read more
Identified HCP (Abbreviation) Tubulin alpha-1C chain (TBA1C)
High risk HCP No
MW (kDa) 49.9
pI 5
UniProt Accession No. P68365
No. of amino acids 449
V-type proton ATPase subunit C 1 (VATC1) No 43.9 7 G3I3N5 382 Read more
Identified HCP (Abbreviation) V-type proton ATPase subunit C 1 (VATC1)
High risk HCP No
MW (kDa) 43.9
pI 7
UniProt Accession No. G3I3N5
No. of amino acids 382
Vimentin (VIME) No 51.8 4.9 P48670 448 Read more
Identified HCP (Abbreviation) Vimentin (VIME)
High risk HCP No
MW (kDa) 51.8
pI 4.9
UniProt Accession No. P48670
No. of amino acids 448

Phorums

Cell & Gene Therapy
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Development Group
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Drug Substance
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Fill Finish
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Information Technology
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Regulatory-CMC
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Supply Chain to Patient
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Supply Partner
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Sustainability
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Technology Strategy
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Cell & Gene Therapy

Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

Drug Substance

Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

Fill Finish

Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges. To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here. 

Information Technology

IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum. 

The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 

Regulatory-CMC

BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, filing and review, interactions with Health Authorities, and harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

Supply Chain to Patient

The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

Supply Partner

BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

  • an enhanced robustness and resilience
  • accelerated capability and capacity to effect technology adoption
  • reduced cost of quality, and
  • industry-wide alignment on operational implementation

There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.

Sustainability

The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

Technology Strategy

With a mission to define strategies to accelerate technology transformation and support the adoption of innovative technologies, BioPhorum Technology Strategy evolved from BioPhorum Technology Roadmapping, strives to realize the technology roadmap vision 2.0.

This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

Best practices for demonstrating comparability for clinical cell-based therapies.
With the increased number of clinical trials using advanced novel cell-based therapies, much of the regulatory and industry guidance needs... read more

How to predict, optimize and analyze high-concentration biologic therapeutic formulations
Developing high-dose biologic drugs for subcutaneous injection often requires high-concentration formulations. It also needs to optimize... read more

A media fingerprinting toolbox that comes with a host of benefits
Cell culture media raw materials can contain many chemical substances, each with its own properties. While simple substances can be... read more

Why 100% visual inspection does not mean 100% defect detection
There is a common misunderstanding that 100% visual inspection (VI) of biopharmaceutical products should mean 100% detection of defects.... read more

How to bridge the data integration gap between sponsors and contract organizations
... read more

Bringing BioPhorum’s unique perspective to continuous manufacturing in biologics
Continuous manufacturing (CM) has been a goal for the pharmaceutical industry for several years. While small molecule drug substances and... read more

Supply Chain to Patient has launched!
Have your outbound supply chain costs increased? Do you want to leverage data and digital technologies more effectively to reduce... read more

Electronic data exchange – the foundation for an efficient, resilient inbound supply chain
The COVID-19 pandemic, geopolitical unrest, and military action across the world have fundamentally disrupted the assumption and practice... read more

How are you improving your environmental sustainability performance?
Climate change and global warming resulting from greenhouse gas emissions are widely recognized as the biggest threats to global health.... read more

Adding value for analytical instrument partners
Analytical instrument vendors have been integral to developing and publishing our technology roadmaps and developing product... read more

MediPhorum

Introducing MediPhorum
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Advanced Wound Care and Wound Management
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Drug Delivery
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Introducing MediPhorum

The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

Introducing the new MediPhorum
MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum
MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum
MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Deliverables

Deliverables Report
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Industry Priorities
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Downloads
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Case Studies
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Webinars and Podcasts
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BioPhorum Deliverables Report
BioPhorum brings you the latest Deliverables Report, an informative and inspiring consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry user requirements, study results, and roadmaps produced in the last twelve months.
Technology Strategy
Buffer stock blending system
Knowledge management
Technology adoption
Operations
Change notification
Closure playbook
Extractables and leachables
In-Line Monitoring and Real-Time Release
Raw materials
Regulatory Governance and External Partners
Single-use systems
Annex 1
Information Technology
Digital integration of sponsor and contract organizations
Digital plant maturity model
IT for cell and gene therapies
Lab of the future
BioPhorum Downloads
Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.
Case Studies
Welcome to the BioPhorum case studies page, where you can learn how our clients have used our service to discover innovative solutions and save money. Here you can read real-life stories of how various organizations have used our unique data-driven approach to streamline their processes and make the most of their resources. Whether you're looking for inspiration or want to learn more about the potential benefits of our service, you'll find it here.
Webinars and podcasts
Welcome to BioPhorum Connect, the podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, this podcast brings you the insights and perspectives of experts from around the world. We'll discuss all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. So, join us on our journey as we explore the world of biopharmaceuticals and learn from the perspectives of those at the forefront of the industry.
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