+441518081136PACKAGING CHALLENGE FOR BIOSIMILAR PRODUCTS
3rd International Conference on MASS SPECTROMETRY, PROTEOMICS AND POLYMER CHEMISTRY
May 20-21, 2019 | Rome, Italy
Anupam Chanda
Indian Institute of Packaging, India
Keynote : J Chem Tech App
Abstract:
Now-a-days Packaging plays a significant role for biosimilar product.
The process of selecting materials and the type of packaging also offers
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 aggregation
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 increase
the risk of glass delamination; high alkali content in glass could
accelerate erosion; high temperature during the vial-forming process increases
the risk of glass delamination; terminal sterilization (irradiated at
20-40 kGy for 150 min) is also a risk factor for specific products (veterinary
parenteral administration), could cause delamination; high product-storage
temperatures and long exposure times can increase the rate and severity
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
glass to ensure its suitability for the pH of the product; use COC/COP vial.
Present market demand is syringe barrel and/or plunger coated with silicone.
Non-uniform silicone coatings can affect protein stability. The proteins can
absorb into the walls of the container. While silicone can reduce absorption,
excess silicone can form suspended oil-like droplets. Proteins can form
around those droplets and change their natural state. New lubricant coatings,
such as inert fluoropolymers, are being introduced to replace silicone.
As a very inert material, fluoropolymer provides smoothness for the syringe
plunger without the irregularities or the issues that have come with silicone.
Other new coating materials are being introduced with new types of packaging
related to self-injectors, especially injector pens, patches, transdermal
and wearable devices for self-infusion. Extractable and leachable are most
important for inhalers and catheters. For an extractables from a device component
the AET (μg/g) can be determined using Equation 1:
Where
Dd- Doses per day
Dt- Total Labelled doses
m- Mass of component
The AET (μg/device) for a drug delivery device (e.g. an MDI) can be determined from Equation 2:
Where
Dd- Doses per day
Dt- Total Labelled doses
Recent Publications
1. Anupam Chanda (2019) Packaging Challenge for Lyophilized Products. Acta Scientific Pharmaceutical Sciences
3.4: 87-91
2. Anupam Chanda (2018) Packaging Challenge for Biosimilar products. J Bioanal Biomed10: 82
Biography:
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