JOIN CRODA PHARMA AT BIOPROCCESS INTERNATIONAL US EAST, BOSTON, MA 2026!
Learn how Croda Pharma continues to develop high-purity ingredients that power your discoveries.
Join our team as we exhibit and present at BPI East 2026. We invite you to visit us at booth #807 to say hello.
What, where, and when?
This is a LIVE IN-PERSON EVENT.
What: BioProcess International East US
Where: John B. Hynes Veterans Memorial Convention Center, Boston MA., booth #807
When: September 22 - 25, 2026
Schedule your meeting at: pharma.usa@croda.com
JOIN DR. GARIMA SINHA, RESEARCH AND TECHNOLOGY MANAGER FOR CELL CULTURE AND UPSTREAM PROCESSING AT HER TALK.
September 25th 12:15pm, cell culture and upstream processing
Title: Purity that powers performance: Enabling consistent bioprocessing outcomes with high-quality excipients
Abstract: Variability in raw materials is an underappreciated source of risk in biomanufacturing, where trace impurities and lot-to-lot inconsistency can compromise cell culture, viral clearance, and product quality. This talk shows how purity and reproducibility across three ingredient classes drive more predictable processes. Super Refined™ Poloxamer 188, with a controlled molecular-weight distribution confirmed by SEC, HPLC-ELSD, and MALDI-TOF from lab to industrial scale, delivers consistent cell protection, faster dissolution, and no free PPG. BioXPro™ multi-compendial amino acids, with ultra-low metals and endotoxin, support healthy cell culture and milder, more efficient chromatographic elution. The Virodex™ TXR-1 and TXR-2 detergents offer a Triton™ X-100 alternative meeting ICH Q5A(R2) expectations, with viral inactivation, cell lysis, protein compatibility, and endotoxin reduction equivalent or superior to incumbent and competitor reagents. Together, these case studies illustrate how high-purity, consistent inputs reduce variability and de-risk biologics manufacturing from cell culture through formulation.
JOIN DR. JINGHAN LI, APPPLICATION SCIENTSIT, CRODA PHARMA
September 23rd, 1:00 pm, Lunch & Learn
Title: Biologic Stability Enhancement: Formulation Strategies and Excipients
Abstract: To improve the stability of biologics, various excipients with distinct functions are incorporated into formulations. In protein formulations, surfactants play a critical role in preventing surface-induced degradation under mechanical stress. In addition to polysorbates, poloxamer 188 is also an alternative option for protein stabilization at a relatively higher concentration ≥0.01% w/v. Although used at low concentrations, the purity of excipients is important to formulation stability. High-purity polysorbates with lower hydrolysis propensity generate less insoluble fatty acid compared to compendial-grade materials. As an alternative surfactant candidate, the results also show that high purity poloxamer 188 also contributed to improved formulation stability by reducing protein unfolding propensity. The importance of surfactant purity can be further extended beyond proteins to other biologic modalities, such as nucleic acid-loaded lipid nanoparticles. Overall, optimizing excipient selection and its high purity is critical to achieving robust and stable biologic formulations.
Explore our poster sessions:
FROM VIRAL INACTIVATION TO FINAL DRUG PRODUCT: HIGH-PURITY SOLUTIONS FOR DOWNSTREAM PROCESSING AND BIOLOGIC FORMULATION
Poster One
Your presenter: Dr. Jinghan Li
High-purity process aids are required to achieve viral safety, purification, and formulation stability in biologics manufacturing. Virodex™ TXR-1, an alkyl alcohol ethoxylate, and TXR-2, an alkyl glyceryl ethoxylate, were evaluated as nonionic alternatives to Triton™ X-100. At 0.1%, both detergents produced viral-inactivation kinetics comparable to or greater than Triton™ X-100 across 15, 22, and 28°C, with reproducible performance at 1, 15, and 120 minutes. Residual TXR-1 was monitored by LC-MS and LC-CAD and decreased from 998 ppm to below the detection limit following sequential AEX, HAC, CEX, UF/DF, and nanofiltration operations. In Protein A chromatography, 2.0 M BioXPro™ arginine hydrochloride at pH 4.4 generated a sharper lebrikizumab elution profile than 0.1 M citrate. In formulation studies, Super Refined™ Polysorbate 80 combined with BioXPro™ histidine retained polysorbate integrity during four weeks at 25°C, whereas compendial comparators showed greater degradation. Collectively, these materials support integrated downstream processing and formulation control.
UPSTREAM EXCELLENCE THROUGH PURITY: ENHANCING CELL CULTURE ROBUSTNESS WITH SUPER REFINED™ POLOXAMER 188 AND BIOXPRO™ AMINO ACIDS
Poster Two
Your presenter: Dr. Kritika Bajaj
Raw-material heterogeneity can compromise reproducibility in intensified cell culture. This study evaluated Super Refined™ Poloxamer 188 and BioXPro™ amino acids as media components for CHO suspension systems. Super Refined™ Poloxamer 188 exhibited a narrow molecular-weight distribution (Mw 7,680–9,510 Da; PDI ≤1.04 by SEC), with no detectable free polypropylene glycol species within the 500–3,000 m/z MALDI-TOF range. At 10% w/w in water, the material dissolved within 20 minutes at 200 rpm and remained stable for six months at 5°C and 25°C. In amino-acid-depleted CHO media, supplementation with 1 g/L poloxamer 188 and BioXPro™ arginine and histidine supported viable cell densities of 9–10 × 10⁶ cells/mL and >90% viability over 96 hours. Comparable performance across three amino-acid lots demonstrated reproducible nutrient functionality. These findings indicate that tightly controlled excipient composition, molecular distribution, and impurity profiles can improve media preparation, culture consistency, and upstream process robustness.
ADVANCING SAFER CRYOPRESERVATION: EVALUATION OF REDUCED DMSO AND DMSO FREE FORMULATIONS WITH BIOCOMPATIBLE EXCIPIENTS
Poster Three
Your presenter: Dr. Garima Sinha
Cryopreservation is critical for the storage, transport, and clinical use of cell-based therapies; however, dimethyl sulfoxide (DMSO), the industry-standard cryoprotectant, presents challenges for cell and gene therapy due to cytotoxicity, regulatory considerations, and potential adverse effects following administration of cryopreserved products. This study evaluated reduced-DMSO and DMSO-free cryopreservation formulations using biocompatible excipients from Croda’s portfolio, with a focus on Super Refined™ Poloxamer 188 as a membrane-protective component. HEK293 cells were cryopreserved in formulations containing varying concentrations of DMSO, Super Refined™ Poloxamer 188, Super Refined™ Polysorbate 80, sucrose, and glycerol, then assessed following thaw and 72-hour recovery. Several reduced-DMSO formulations outperformed the conventional 10% DMSO control. Formulations containing Super Refined™ Poloxamer 188 achieved ≥90% post-thaw viability and ≥90% confluency within 72 hours, demonstrating effective protection during freezing and thawing. These results highlight a promising strategy to reduce DMSO exposure while maintaining robust cryopreservation performance for cell therapy applications.
Request a meeting today below!
Event type: Exhibition
BioProcess International US East
Bioprocess International (BPI) is the largest bioprocessing event, bringing you new ideas, demystifying technology, and fostering partnerships to move drug candidates closer to approval. Visit us at booth #807, attend our technical presentation “Purity that Powers Performance: The foundation of batch-to-batch consistency in bioprocessing highlighting Super Refined™ Poloxamer 188, BioXPro™ Amino” on September 25th at 12:15pm. Schedule your meeting today and set up a meeting by using the form below!
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