Question

iii. You are an engineer working for a biopharmaceutical company and have to design a precipitation system. Determine the safest procedure for the establishment and list down important considerations in the process.

Answer 1

Design of precipitation will depend upon various applications in biopharmaceutical applications itself such as Crystallization and purifying therapeutic proteins etc. If the precipitation followed by crystallization there are parameters such as nucliation, mixing efficiency, crystal size and crystallization kinetics etc will play a vital role. Here it is assumed to be application based on purification of protein like antibodies from biological sources. Here we can see the detailed parameters step wise in the figures.

Quality by design QLD) approach can be used and Second for precipitation stars invowed in roman of impurities in biopharmaceutical applications. Two step approach in which the first step focus on ponduct Quality on procese performance. Here we can see the case study for Characterisation of precipitation using Sodium Caprolate' to reduce host call proten (HCP). during mono Clinical andstody purificatson outputs analysed Step 1 multivariate study process parameters Studied SpH for precipitation arount of Socinum Caprylate adoled Hep monomer purity Charge Variants focused on product quality. Hold time. Temperature, ch here process paramotors with significant impact & and Carried to step 2. P Step 2 multivariate study. focused . step yield pilter Capability pH for precipitation Amount of Sodium Cap dylate on process added Monitored performance • Hold time • Hep Agitation rate Filter flux Hep Content in .monomer puenity charge Varhants . material starting precia Risk assessment for the QbD approach described process parameters asscociated with pikunion step, the corresponeling ranges that were assessed, the more score associated with or the extent of impact from Each procen palauater on the relavent outputs, pH, amount of Capriate akded, temperature, held time, agitation rate, filter flax and Hop in Harling material will impact prodult quality & process performance,