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WHITE PAPERS AND CASE STUDIES

• Vial Fogging: Practical Considerations For Vial Selection

  Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.

• Overcoming HCP Co-Elution Issues Using Cell Line Engineering

  Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that took an alternative approach by utilizing cell line engineering.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• Optimizing Poloxamer 188

  Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.

• Optimizing Upstream Process Development To Increase mAb Titers

  Uncover how we were able to help a client develop an efficient upstream process for a novel monoclonal antibody (mAb), resulting in a more than 100% increase in titers.

• Membrane Adsorber Chromatography In Oligo-mAb Conjugation

  Discover how the team was able to expedite the conjugation of an oligonucleotide-monoclonal antibody (oligo-mAb) program leveraging experience in chromatography.

• Drinking Water Disinfection At Lunenberg, Massachusetts, USA Local Community

  In this case study, read how the Lunenburg Water District improved their water disinfection system with the installation of an Atlantium RZ300-11 HOD UV system. The system effectively disinfects water, meets future demands, and eliminates chlorine taste and odor.

• Leveraging The Immunological Diversity Of The Pentamice® Platform For Covid-19 Antibody Discovery

  Consider this alternative immunization approach — the PentaMice platform, a collection of five wildtype mouse strains bred in-house for increased MHC class II diversity — and how we're leveraging it for COVID-19 antibody discovery.

• How Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• Bringing Clinical Testing To New Heights In New Jersey

  Explore how clinical testing was transformed with a pioneering BSL-2 mobile laboratory on a Sprinter Van platform to enhance safety and portability for advanced biosafety requirements.

• Labware Washing Techniques And The Sinner's Circle

  Explore labware cleaning techniques, comparing manual and automated processes, and how balancing the four factors of the Sinner’s Circle ensures effective, repeatable laboratory outcomes.