Newsletter | March 23, 2020

03.23.20 -- FDA FY2019 Warning Letter Trends: A Closer Look At Drug Product Manufacturers

  In Vivo Models And In Vitro Assays For Human RSV Infection: Preclinical Antibody, Small Molecule, And Vaccine Development

Epidemiological data indicates that over 3 million children under age 5 are hospitalized with respiratory syncytial virus (RSV)-related infections annually, resulting in more than 200,000 deaths. As there remains no licensed vaccine product, disease due to RSV infection remains an unmet medical need. In vitro and in vivo models for RSV vaccine development provide a critical component in development of anti-RSV antibodies, small molecules, and vaccines.

Featured Editorial
FDA FY2019 Warning Letters: A Closer Look At Drug Manufacturers
By Barbara Unger, Unger Consulting Inc.

Part two of this series takes a deep dive into the types of drug manufacturers that received warning letters, and their locations, including data on how frequently the FDA recommends that firms hire qualified consultants and its request for “independent assessments” in warning letters.

The Microbiome Market Boom: 4 Factors Biopharma Needs To Know
By Jenna Phillips and Esther Ketelaars, PA Consulting

Investment in the microbiome category is increasing as VCs and biopharma companies make investments and establish partnerships with startups that are commercializing novel offerings in the space.

Industry Insights
Can You Trust A Machine For Downstream Bioprocess Buffer Preparation?
Article | By Enrique Carredano, GE Healthcare Life Sciences

Is automated buffer preparation a solution to the dilemma of balancing increased production capacity against limited footprint expansion alternatives?

Microbiology Fills QC Role At A CDMO In Aseptic Filling And Sampling
Article | By Summer Wade, Singota Solutions

Microbiological contamination is at the top of the CDMO threat list. A CDMO needs to have clearly defined procedures and allow clients access to data.

Choosing The Best Sterile Dosage Form For Your Phase 1 Needs
White Paper | By Tony Pidgeon, Thermo Fisher Scientific

When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices — choices that can be conflicting or present differing advantages.

Coronavirus Outbreak: Manufacturing And Supply Chain Lessons Learned
Article | Argonaut Manufacturing Services

The COVID-19 outbreak reveals important lessons on supply chain integrity. While events such as this are impossible to completely prepare for, safeguards can reduce timelines and shorten supply impacts.

Solving The Challenge Of Comparator Drug Procurement
Case Study | Thermo Fisher Scientific

A leading pharmaceutical company needed assistance in obtaining comparator study medication for a global Phase 3 program. The global trial was focused on an infectious disease and involved 130 sites.

Expediting A Promising New Therapy
Case Study | Catalent

A biotech exploring novel therapeutics for neuroscience indications developed a promising new chemical entity to treat a severe pediatric genetic disease. Softgel technology expedited its Phase 2/3 clinical trial.

Modified Purification Process For A mAb Therapeutic-Yield Improvement
Case Study | Cytovance Biologics

How one firm improved yield of monoclonal antibody (mAb) product from bulk harvest 1.8 fold by simplifying the downstream process and eliminating the use of resins that resulted in declining yields with short life cycles.

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