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Packaging Material Screening and Testing Services for Protein & Peptide Formulation

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The selection and evaluation of inner packaging materials are important aspects that cannot be ignored in drug development. CD Formulation will comprehensively consider factors such as drug characteristics, packaging methods, quality standards, stability, protective performance, and sustainability based on the characteristics of your product to ensure the quality and safety your product. Whether you require packaging material screening and testing services for therapeutic protein and peptide formulation development, or support for other types of packaging projects, we can provide you with professional service and support.

What is Packaging Material?

In the development process of therapeutic protein and peptide biological products, inner packaging materials usually refer to a type of material that directly contacts the drug, protects the drug ingredients from damage, controls the release rate, improves stability, and improves drug efficacy. For drug development, the selection and evaluation of inner packaging materials is a crucial step. Appropriate inner packaging materials can ensure the quality and stability of therapeutic protein and peptide products, and ensure the effectiveness and safety of drugs. Several factors need to be considered when selecting inner packaging materials, including the material's chemical stability, transparency, moisture resistance, oxygen permeability, permeability resistance, and corrosion resistance. In addition, the compatibility of the inner packaging material with the drug and its impact on the safety and effectiveness of the drug also need to be considered. Common inner packaging materials include polymer, glass, metal, and other materials.

Explore Our Packaging Material Screening and Testing Services

With decades of successful experience and extensive expertise in packaging projects, CD Formulation is committed to utilizing the latest technologies and guidelines to provide our customers with packaging material screening and testing services for therapeutic protein and peptide formulation development.

Our analytical laboratories are equipped with state-of-the-art equipment to assist you in designing the best packaging solutions, covering packaging material compatibility testing, analytical method development and validation, and related analytical testing services. Importantly, all of our protocols meet regulatory requirements, ensuring your product meets regulatory requirements and is approved for market.

Fig. 1 Packaging material screening and testing services. (CD Formulation)

Available Testing Projects and Analytical Technologies:

Services	Description
Packaging Material Screening	Find, screen, purchase and test packaging materials according to your therapeutic protein & peptide delivery route to ensure the smooth production of your products and timely and effective entry into the market.
Packaging Material Compatibility Testing	Evaluate the packaging material-drug relationship based on the type and physicochemical properties of contact material , its manufacturing processes,such as the type of sterilization that could potentially alter the interactions, and the formulation components involved in contact with this material, including: Stability studies: Used to monitor whether therapeutic proteins & peptides are stable after long-term contact with packaging materials. Migration testing: Used to monitor substances that migrate from packaging materials and into formulations. Toxicity testing: Especially cytotoxicity testing, used to evaluate whether packaging materials are safe.
Packaging Material Sealing Testing	According to the newly revised United States Pharmacopeia (USP) General Chapter <1207>, select the best test combination for your product packaging material selection for sealing testing, including: Helium (He) leak testing. Vacuum decay testing. Laser-based headspace analysis (HSA) testing. Dye ingress testing. Laser-drilled micro holes testing. Copper wire introduced leaks testing. Capillary leaks testing.
Extractables and Leachables Testing	Evaluate a class of compounds extracted from container closures or leached into therapeutic protein & peptide formulations, including: Method development for extractables and leachables analysis. Inorganic and organic extractables analysis. Leachable stability studies. Chromatographic and spectroscopic characterization, including UPLC/HPLC (UV, PDA, Fluorescence, ELS, RI, CAD, MS, MS/MS), gas chromatography (liquid, headspace, solid-phase microextraction, FID, MS, MS/MS), FT/IR, Morphological characterization, including,x-ray fluorescence analysis (XRF), atomic force microscope (AFM), electron probe microanalyzer (EPMA), etc.

Why Choose Us for Packaging Material Screening and Compatibility Testing?

Has a comprehensive range of platform materials to support the selection of packaging materials for different dosage forms.
Flexible custom solutions that comply with packaging material testing guidelines.
Extensive experience and expertise in packaging material testing to handle every possible complex challenge.
Extensive testing technology and equipment to identify and quantify extractable and leachable impurities that may be introduced by various packaging materials.

Publication

Published Data

Technology: Microchambers-Thermal Extraction and Pyrolysis-Gas Chromatography-Mass Spectrometry

Journal: Molecules

IF: 4.6

Published: 2020

Results:

The authors developed a method to identify potential leachables in plastic packaging materials by using two methods based on solvent-free extraction, namely solid phase microextraction sampling and pyrolyzer/thermal desorption combined with gas chromatography-mass spectrometry. The results show that this method can effectively identify 35 compounds related to the polymer industry or packaging industry, including degradation products, impurities, additives, plasticizers, monomers, etc.

The pictures of their study results are shown as follows.

Fig. 2 Structures of the compound belonging to Cramer class III. Fig. 2 Structures of the detected compounds belonging to the Cramer class III. (Murat P, et al., 2020)

At CD Formulation, we are not only committed to providing high-quality packaging material screening and testing services but also to building long-term relationships with our customers to help them succeed in the highly competitive market. Our team of experienced experts provides clients with customized solutions and ensures projects are delivered on time and to quality standards. Please contact us today if you are interested in our services. We look forward to working with you.

References

Laschi A, Sehnal N, Alarcon A, et al. Container-content compatibility studies: a pharmaceutical team's integrated approach. PDA J Pharm Sci Technol. 2009, 63(4):285-93.
Brown H, Mahler HC, Mellman J, et al. Container Closure Integrity Testing-Practical Aspects and Approaches in the Pharmaceutical Industry. PDA J Pharm Sci Technol. 2017, 71(2):147-162.
Li K, Rogers G, Nashed-Samuel Y, et al. Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products. PDA J Pharm Sci Technol. 2015, 69(5):590-619.
Murat P, Harohalli Puttaswamy S, Ferret PJ, et al. Identification of Potential Extractablesand Leachables in Cosmetic Plastic Packagingby Microchambers-Thermal Extraction and Pyrolysis-Gas Chromatography-Mass Spectrometry. Molecules. 2020, 25(9):2115.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.

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