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Investigating thermally induced aggregation of Somatropin- new insights using orthogonal techniques

Västberg, Amanda (author)
Lunds universitet,RISE,Kemiska processer och läkemedel,Lund University, Sweden,Avdelningen för livsmedel och läkemedel,Institutionen för processteknik och tillämpad biovetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Division of Food and Pharma,Department of Process and Life Science Engineering,Departments at LTH,Faculty of Engineering, LTH,Research Institutes of Sweden (RISE)
Bolinsson, Hans (author)
Lund University,Lunds universitet,Avdelningen för livsmedel och läkemedel,Institutionen för processteknik och tillämpad biovetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Division of Food and Pharma,Department of Process and Life Science Engineering,Departments at LTH,Faculty of Engineering, LTH
Leeman, Mats (author)
Solve Research & Consultancy, Sweden,SOLVE Research and Consultancy AB
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Nilsson, Lars (author)
Lund University,Lunds universitet,Avdelningen för livsmedel och läkemedel,Institutionen för processteknik och tillämpad biovetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Division of Food and Pharma,Department of Process and Life Science Engineering,Departments at LTH,Faculty of Engineering, LTH
Nylander, Tommy (author)
Lund University,Lunds universitet,NanoLund: Centre for Nanoscience,Annan verksamhet, LTH,Lunds Tekniska Högskola,Fysikalisk kemi,Enheten för fysikalisk och teoretisk kemi,Kemiska institutionen,Institutioner vid LTH,LTH profilområde: Nanovetenskap och halvledarteknologi,LTH profilområden,LU profilområde: Ljus och material,Lunds universitets profilområden,Other operations, LTH,Faculty of Engineering, LTH,Physical Chemistry,Physical and theoretical chemistry,Department of Chemistry,Departments at LTH,Faculty of Engineering, LTH,LTH Profile Area: Nanoscience and Semiconductor Technology,LTH Profile areas,Faculty of Engineering, LTH,LU Profile Area: Light and Materials,Lund University Profile areas
Sejwal, Kushal (author)
Vironova AB, Sweden
Sintorn, Ida-Maria (author)
Vironova AB, Sweden
Lidayová, Kristina (author)
Vironova AB, Sweden
Sjögren, Helen (author)
Ferring Pharmaceuticals, Denmark,Ferring AB
Wahlgren, Marie (author)
Lund University,Lunds universitet,Avdelningen för livsmedel och läkemedel,Institutionen för processteknik och tillämpad biovetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Division of Food and Pharma,Department of Process and Life Science Engineering,Departments at LTH,Faculty of Engineering, LTH
Elofsson, Ulla (author)
RISE,Kemiska processer och läkemedel,Research Institutes of Sweden (RISE)
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 (creator_code:org_t)
Elsevier B.V. 2023
2023
English.
In: International Journal of Pharmaceutics. - : Elsevier B.V.. - 0378-5173 .- 1873-3476. ; 637
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • Three orthogonal techniques were used to provide new insights into thermally induced aggregation of the therapeutic protein Somatropin at pH 5.8 and 7.0. The techniques were Dynamic Light Scattering (DLS), Asymmetric Flow-Field Flow-Fractionation (AF4), and the TEM-based analysis system MiniTEM™. In addition, Differential Scanning Calorimetry (DSC) was used to study the thermal unfolding and stability. DSC and DLS were used to explain the initial aggregation process and aggregation rate at the two pH values. The results suggest that less electrostatic stabilization seems to be the main reason for the faster initial aggregation at pH 5.8, i.e., closer to the isoelectric point of Somatropin. AF4 and MiniTEM were used to investigate the aggregation pathway further. Combining the results allowed us to demonstrate Somatropin's thermal aggregation pathway at pH 7.0. The growth of the aggregates appears to follow two steps. Smaller elongated aggregates are formed in the first step, possibly initiated by partly unfolded species. In the second step, occurring during longer heating, the smaller aggregates assemble into larger aggregates with more complex structures. © 2023 The Author(s)

Subject headings

NATURVETENSKAP  -- Kemi -- Fysikalisk kemi (hsv//swe)
NATURAL SCIENCES  -- Chemical Sciences -- Physical Chemistry (hsv//eng)
TEKNIK OCH TEKNOLOGIER  -- Annan teknik -- Livsmedelsteknik (hsv//swe)
ENGINEERING AND TECHNOLOGY  -- Other Engineering and Technologies -- Food Engineering (hsv//eng)

Keyword

human growth hormone
differential scanning calorimetry
photon correlation spectroscopy
Calorimetry
Differential Scanning
Dynamic Light Scattering

Publication and Content Type

ref (subject category)
art (subject category)

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