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Mass Spectrometry Congress 2019 Journal of Chemical Technology and Applications | Volume 3
Page 17
May 20-21, 2019 | Rome, Italy
MASS SPECTROMETRY,
PROTEOMICS AND POLYMER CHEMISTRY
3rd International Conference on OF EXCELLENCE
IN INTERNATIONAL
MEETINGS
YEARS
PACKAGING CHALLENGE FOR
BIOSIMILAR PRODUCTS
Now-a-days Packaging plays a significant role for biosimilar product.
The process of selecting materials and the type of packaging also of-
fers an opportunity for the Packaging scientist to look for new biological
delivery choices. Most injectable protein products were supplied in some
sort of glass vial, prefilled syringe, and cartridge. Those products having
high pH content there is a chance of “delamination” from inner surface
of glass vial. With protein-based drugs, the biggest issue is the effect of
packaging derivatives on the protein’s three-dimensional and surface
structure. These are any effects that relate to denaturation or aggrega-
tion of the protein due to oxidation or interactions from contaminants or
impurities in the preparation. The potential for these effects needs to be
carefully considered in choosing the container and the container closure
system to avoid putting patients in jeopardy. Causes of Delamination:
Formulations with a high pH include phosphate and citrate buffers in-
crease the risk of glass delamination; high alkali content in glass could
accelerate erosion; high temperature during the vial-forming process in-
creases the risk of glass delamination; terminal sterilization (irradiated at
20-40 kGy for 150min) is also a risk factor for specific products (veterinary
parenteral administration), could cause delamination; high product-stor-
age temperatures and long exposure times can increase the rate and se-
verity of glass delamination; how to prevent delamination; treating the
surface of the glass vials with materials, such as ammonium sulphate or
siliconization can reduce the rate of glass erosion; consider alternative
sterilization methods only in rare cases; the correct specification for the
Anupam Chanda, J Chem Tech App 2019, Volume 3
Anupam Chanda has his expertise in creating
innovative design in packaging material and
device for Biologics, bio similar, anti-Cancer and
HIV products. He is having two decades (approx.
25 years) of experience in India and abroad. He
is a renowned speaker, widely travel throughout
the world. He gain and share his thoughts with
scientist from various institution and industry
professionals. Author’s Technical book “PACK-
AGING TECHNOLOGY AN ADVANCE PRACTICAL
APPROACH” published from Germany and Am-
azon is distributing among 77 countries. He is
attached with various charitable institutions and
research institutes.
Anupam Chanda
Indian Institute of Packaging, India
BIOGRAPHY