GUEST COLUMNISTS

• TFF Offers Ideal Anaerobic, GMP Conditions For LBP Concentration

  When configured correctly, TFF provides the gentle processing environment and oxygen protection required for strict anaerobes.

• Ask The Pros — The Latest In HCP Monitoring

  Established methods focused on counting all HCPs indiscriminately. Now, a new wave of sophisticated monitoring offers clearer impurity profiles.

• An End-To-End Automated HTP Platform For Cell Line Optimization

  Bristol Myers Squibb's high-throughput stable CHO platform produces high-titer, high-quality material in a fraction of the conventional timeline.

• Here's What You Need To Know About The Access Consortium Pathway

  Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.

• FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK

  The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.

• Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations

  A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

• Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development

  The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.