Engineering makes phage definable enough for conventional approval
A wild-type phage isolated from sewage and matched to a patient's bacterial strain is genetically variable and impossible to define as a fixed product. Engineered phage built to a specified genome, including CRISPR-enhanced constructs designed to kill rather than merely lyse, can be characterised, manufactured consistently and protected by patent. That converts an intractable regulatory object into an ordinary biological medicine. The trade is that engineered constructs lose some of the adaptability that makes natural phage interesting, which several developers regard as an acceptable price. Regulators review specifications, and a specification is exactly what wild phage cannot supply.
Market Impact: Restrictions across 3 major regions








