Study of Protein Adsorption During Sterile Filtration of Protein Formulations by ILC

Haindl, Susanne; Doppleb, Olivia; Förster, Lucas; Wraage, Sophia; Reiche, A.

doi:10.1002/cite.201900185

Cited by 5 publications

(3 citation statements)

References 16 publications

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“…A variety of factors are involved in protein adsorption to filters, such as the hydrophilicity/hydrophobicity of the filter surface, the constituents of the filtered solvent (ionic strength, excipients, and pH), electrostatic charges of the filter surface, and the inherent protein characteristics such as charges and three-dimensional structure [ 28 , 29 ]. Even though these phenomena may be less relevant for peptides, a hydrophilic polyvinylidene fluoride (PVDF) filter that is known for a low protein adsorption was chosen.…”

Section: Discussionmentioning

confidence: 99%

Development of a Personalized Tumor Neoantigen Based Vaccine Formulation (FRAME-001) for Use in a Phase II Trial for the Treatment of Advanced Non-Small Cell Lung Cancer

Oosting

Franke²,

Martin³

et al. 2022

Pharmaceutics

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Stage III–IV non-small cell lung cancer (NSCLC) is a devastating disease characterized by a poor prognosis. NSCLC tumors carry genetic mutations, which can lead to the expression of altered protein sequences. Peptides originating from mutated proteins and bound to MHC molecules on the tumor cell surface are referred to as neoantigens, as they are tumor-specific and not expressed in normal cells. Due to their tumor specificity, neoantigens have a strong potential to induce an anti-tumor immune response and have been investigated for development of personalized therapeutic cancer vaccines. The current study describes the development of a clinical grade neoantigen vaccine formulation (FRAME-001) intended as immunotherapy in advanced NSCLC in combination with the immune checkpoint inhibitor pembrolizumab. The detection of aberrant tumor-specific transcripts as well as an algorithm to select immunogenic neoantigen peptides are described. Subsequently, selected neoantigen peptides were synthesized with a high throughput synthesis platform and aseptically formulated under good manufacturing practice (GMP) conditions into four aqueous peptides mixtures that each contained six neoantigen peptides. A validated stability-indicating analytical method was developed in which we considered the personalized nature of the formulation. An extensive stability study performed either at −25 °C or −80 °C showed that the formulation was stable for up to 32 weeks. The formulation was mixed with the vaccine adjuvant Montanide ISA 51 VG, which yielded the final vaccine emulsion. The stability of the vaccine emulsion was demonstrated using microscopic examination, differential light scattering, and the water-drop test. The presented data show that FRAME-001 is a feasible personalized vaccine formulation for the treatment of stage III–IV NSCLC. The presented data may give guidance in the development of novel personalized therapeutic vaccines since this formulation strategy could be used for any cancer indication.

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Section: Discussionmentioning

confidence: 99%

Development of a Personalized Tumor Neoantigen Based Vaccine Formulation (FRAME-001) for Use in a Phase II Trial for the Treatment of Advanced Non-Small Cell Lung Cancer

Oosting

Franke²,

Martin³

et al. 2022

Pharmaceutics

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“…Mahler et al (2010) 49 noted the protein loss for a mAb ranging from undetectable to about 1−2 mg/cm 2 for PES and PVDF membranes from different suppliers, and up to about 113 mg/cm 2 for nylon filter membrane. A recent report 50 using bovine serum albumin and g-globulin formulations showed adsorption of 15 mg/cm 2 .…”

Section: Sterile Filtrationmentioning

confidence: 96%

Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality

Das

Sreedhara²,

Colandene

et al. 2022

Journal of Pharmaceutical Sciences

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“…Because of their low tendency towards protein adsorption resulting in a minimal fouling behavior, porous membranes based on regenerated cellulose are widely used for filtration and purification applications in biopharmaceutical downstream processing 1, 2. Due to the intrinsic hydrophilicity of cellulose and its extraordinary supramolecular structure caused by very strong hydrogen bonds, these membranes do not need any prewetting before use and are highly compatible with many organic solvents.…”

Section: Cross‐linking Of Cellulose Membranes With Bifunctional Epoxidesmentioning

confidence: 99%

Kinetic Parameters of the Cross‐linking Reaction of Cellulose Membranes with Bifunctional Epoxides

Ruhr

Reiche

2022

Chemie Ingenieur Technik

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Kinetic parameters of the cross-linking reaction of porous cellulose membranes with aqueous solutions of two different diglycidyl ethers were determined by dynamic DSC experiments. The autocatalytic reaction behavior was described with an extended Prout-Tompkins equation. Kinetic analysis revealed a similar kinetic behavior for both diglycidyl ethers, with an apparent activation energy of 45-65 kJ mol -1 and a reaction order between 0.9 and 1.5, suggesting a transition from one to another dominant reaction mechanism when the composition of the cross-linking solution is changed. Conversion curves based on the kinetic analysis serve as a basis for the design and optimization of a continuously running process for the industrial-scale production of cross-linked cellulose membranes.

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Study of Protein Adsorption During Sterile Filtration of Protein Formulations by ILC

Cited by 5 publications

References 16 publications

Development of a Personalized Tumor Neoantigen Based Vaccine Formulation (FRAME-001) for Use in a Phase II Trial for the Treatment of Advanced Non-Small Cell Lung Cancer

Development of a Personalized Tumor Neoantigen Based Vaccine Formulation (FRAME-001) for Use in a Phase II Trial for the Treatment of Advanced Non-Small Cell Lung Cancer

Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality

Kinetic Parameters of the Cross‐linking Reaction of Cellulose Membranes with Bifunctional Epoxides

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