Manufacturing processes typical profile

Comparability is the hallmark in terms of biosimilarity and/or bioequivalence. Comparability must take into account whether there are any variations in the existing manufacturing process. Typically, manufacturers wish to demonstrate that the originator s products, as well as being competitive, have similar profiles. In terms of safety, efficacy, and quality, EMEA will evaluate all products that fit into this category on a case-by-case basis. Moreover,... 

A reconstructed ion chromatogram (GC-MS) containing extractable contaminants isolated from a typical lot of foam is shown in Figure 4. The qualitative composition of the extractable contaminants was provided by GC-MS. Contaminant profiles were identical for each of the two solvent systems employed, methylene chloride (1003 ) and ethyl ether/hexane (5/95). The contaminant chemistry shown here and again in Figure 5 in several instances is consistent with the manufacturing process data shown in the box, most notably the presence of residual toluene diisocyanate (starting materials, see Scheme II) and an aliphatic amine (possible reaction catalyst). 

PVC plastisols or pastes should have a viscosity suitable for handling and storage, as well as the manufacturing process. This is necessary for thinning under the appropriate shear conditions. Paste PVC resins (or blends of resins) are designed to satisfy a particular rheology profile, but sometimes the addition of viscosity modifiers is necessary. Fumed silicas are typically used. Calcium sulfonate gels have also been promoted (458). 

Pultmded profiles have participated competitively in markets like electrical, corrosion, construction, transportations, as well as aerospace and defense. Figure 1 shows some of the typical profiles manufactured by this process. 

The assessment of material quality normally starts with comparing a material s attributes to the specifications established by the purchasing company. Once the material satisfies established specifications, efforts are made to assess the stability of the product or intermediate manufactured with the material. Typically the determination of raw material process stability is made during the product development activities. Once a vendor or vendors have been selected, three distinct vendor lots of a given raw material will be purchased. Development batches of the product are then produced using these lots, and samples from the three batches are placed on stability. The thought is that if the materials from the three lots result in product with suitable stability profiles, the raw... 

---