Raw materials in the manufacture of biotechnology products: Regulatory considerations
Page 1 Raw materials in the manufacture of biotechnology products: Regulatory …

to maintain and keep clean, and able to house the required processing equipment. Space
must be provided to allow for an orderly arrangement of processing equipment that will …

As the production of biologics grows, so does the need to control impurity contamination.
Some compounds have the possibility to leach into the products during their manufacturing …

Raw materials are critical components of product manufacture; these include source
materials such as cell substrates, tissues, and biological fluids required for product …

The biopharmaceutical industry has increased the number of cell and gene therapy
medicinal products under development. The complexity of the new technologies to enable …

52 BioProcess International 13 (3) March 2015 those parts that are unnecessary. The result
is a set of costeffective raw materials that are designed for bioprocessing. In such cases, a …

Elemental metals are critical raw material attributes which can impact cell culture
performance and associated therapeutic protein product quality profiles. Metals such as …

Quality assurance for finished pharmaceuticals, biopharmaceuticals, medical devices, and
active pharmaceutical ingredients (APIs) includes the specification and control of those …

Twenty brands of soft drinks commonly consumed in Lagos, Nigeria were analyzed for lead,
cadmium, nickel, silver, chromium and zinc using standard biochemical procedures. The aim …

The root cause of contamination incidents in recent years is most likely the use of
contaminated raw materials. These include bovine serum contaminated with reovirus …