For most of its existence, bioprocessing was an industry almost no one outside of it had ever heard of — the unseen manufacturing arm behind every biologic, doing its work several layers removed from public view. That changed, briefly and dramatically, during the COVID-19 pandemic. As the world raced to manufacture vaccines at a scale…
Biologics manufacturing is more commonly referred to as bioprocessing given that the biologic that is being manufactured follows an atypical path than what is common to manufacturing. Biologics vary in their chemical and organic structure from “small molecule” drugs such as Tylenol or Advil. While these small molecule drugs have a defined chemical composition, which…
Bioprocessing is one of the stickiest markets in life sciences, and that stickiness is exactly what makes it difficult to enter. Once a biologics manufacturer qualifies a raw material, a piece of equipment, or a single-use component for a given process, switching suppliers means re-validating the change with regulators, re-running stability studies, and in many…
When biologics manufacturers procure equipment, supplies, or software, they are not simply comparing specifications and price. Bioprocessing purchasing decisions carry consequences that extend across the full lifespan of a therapeutic — often two decades or more — which means the criteria customers apply look very different from a typical industrial procurement process. Understanding those criteria…
Biopharma companies apply a distinct, risk-driven lens when sourcing suppliers, vendors, and partners — one shaped less by cost optimization than by the consequences of supply failure in a regulated, patient-facing manufacturing environment. Firms looking to enter the industry, or to grow an existing bioprocessing relationship, need to understand that biopharma sourcing decisions are built…
Single-use technology has become the default manufacturing platform across much of bioprocessing, and the films that form bioreactor bags, tubing, and storage containers are not interchangeable commodities. The specific polymer construction of a single-use film determines whether it protects the biologic inside it or quietly compromises it — and materials science in this space has…
The FDA defined the Process Analytical Technologies framework in 2004 to address a structural inefficiency in pharmaceutical and biologics manufacturing: most quality control was retrospective, confirming after the fact whether a batch met specification rather than actively managing the process to ensure it would. PAT was built to shift that paradigm — from testing quality…
The FDA defines a critical quality attribute, or CQA, as a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. For biologics manufacturers, and particularly for cell and gene therapy developers, identifying and controlling the right CQAs is one of…
The single biggest challenge facing advanced therapies — the category once known narrowly as cell and gene therapy but now expanded to cover newer platforms including mRNA, engineered bacteriophage, and gene editing technologies — is manufacturing and scale-out. Understanding why requires understanding how fundamentally these therapies differ from the traditional biopharmaceutical manufacturing model that preceded…
During the 1960s and 1970s, NASA developed a framework — now known as Technology Readiness Levels, or TRL — to benchmark every technology used in space applications against a single standardized maturity scale, understood consistently across the entire space program. The need for TRL emerged from a specific operational problem: NASA wanted to incorporate the…