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WHITE PAPERS AND CASE STUDIES

• Generation Of A Contamination Control Strategy

  An unaddressed compliance issue related to contamination control can pose a significant risk to a life sciences organization. This case study details a company's journey toward sustainable compliance.

• Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends

  Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

• A Strategic Guide For Biotech And Biopharma Leaders

  Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.

• 5 Essential Capabilities For Decentralized Clinical Trials

  Learn how to develop and utilize a successful DCT framework, enabling your study to enhance patient access, improve data quality, and streamline study operations.

• Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility

  The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.

• How To Unlock The Secret To Repeatable, Scalable Low Turnover

  Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.

• Standardize Flow Cytometry Data With Easy Assay Transfer Across Sites

  Gain insight into how a global pharmaceutical company successfully transferred their cell therapy assays across international locations.

• Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy

  Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

• Operational Success By Strategic Investment

  Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.

• Streamlining ADC Development: Advantage Of An All-In-One Solution

  Antibody-drug conjugate (ADC) development requires tightly integrated manufacturing. Streamlined, end-to-end solutions reduce complexity, improve quality, and accelerate time-to-market.

• Insights And Effective Strategies For A Successful Technology Transfer

  Discover key strategies for seamless pharmaceutical technology transfers that accelerate time to market, ensure product quality, and meet regulatory standards across the drug lifecycle.

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.