Articles in this Issue

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  The Patient Journey Tech Stack: 10 Predictions for 2023

  The complexity of demands on Market Access teams has increased in recent years, between introducing innovative therapies targeting smaller populations and higher bars from Payers and PBMs. Now, ... read more
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  Cleaning, Disinfection and the Problems Caused by Chemical Residues

  Cleaning and disinfection are necessary protective and reactive steps to address microbial deposition on surfaces within pharmaceutical cleanrooms. An appropriately designed cleaning and disinfection ... read more
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  A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy...

  While on the leading edge of many medical breakthroughs, cell and gene therapy manufacturers often face historically problematic concerns when controlling for contamination in their cleanroom ... read more
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  Is the COVID-19 mRNA Vaccination Safe in HIV-1 and Other Retroviral Infections?

  Translocation from cytoplasm to nucleus and integration of reverse-transcribed SARS-CoV-2 spike mRNA into the genomic DNA of COVID-19 mRNA-vaccinated individuals positive for HIV-1 or other retroviral... read more
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  How to Implement Scalable Allogeneic Source Material Collection Processes to Avoid First Collection...

  Many allogeneic cell therapies in development today require the use of starting material collected at an apheresis center from a healthy adult donor. As a therapy reaches late-stage clinical trials ... read more
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  The Lifecycle from Drug Development Through Approval Processes

  The average lifecycle of drug development from discovery to approval is about 10 to 12 years. The total time varies depending on the previous knowledge and experience gained by similarity to an ... read more
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  Protein Tagging Strategies for Analytical and Preparative Purifications

  When proteins are overexpressed in cells for studying these proteins either within the cellular host or as a purified preparation, it is quite common that researchers add one or more of a variety of ... read more
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  Establishing a Robust Quality System in a 503B Outsourcing Facility

  A sterile compounding pharmacy can elect to register with FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act, as added by the Drug Quality and Security Act, ... read more
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  EU GMP Annex 1 – The Compliance Clock Is Ticking

  In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new provisions must be ... read more
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  Pharmaceutical P.I.N. Points: Patent Innovation News

  The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in November-December, 2022. read more
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  Message from the Editor: Hitting it Big - Almost

  Do you play the lottery? I do – despite knowing the odds of winning are infinitesimally small. But who wouldn’t want to win all that money? Money doesn’t buy happiness – but I would like to try it... read more