2024年1月15日星期一

How polymer vial protects drug safety

Pharmaceutical packaging plays a vital role in ensuring drug quality and patient safety. For some special drugs, ordinary packaging methods may not meet their storage and transportation needs. At this time, Polymer vials have become an ideal choice to protect drug safety.

The full name of COP vial is cycloolefin pharmaceutical polymer vial, which is a special high-performance packaging material. It has the characteristics of high transparency, low birefringence, low water absorption, high rigidity, low temperature resistance, good water vapor airtightness, etc., and complies with FDA standards. Because of these unique properties, it has wide application value in the field of pharmaceutical packaging.

Pharmaceutical packaging CZ vial instead of glass bottle

Crystal Zenith vial

First of all, for high value-added and easily damaged drugs, such as lymphocyte antigens, hormone drugs, anesthetic drugs, etc., excellent mechanical properties of packaging have become the key to their safe transportation. It has high tensile strength and elastic modulus and can effectively resist external pressure to ensure that the drug is not damaged during transportation.

Secondly, for drugs with a pH value greater than 9, traditional glass bottle packaging may cause detachment and metal ion precipitation, which is not conducive to the storage of drugs. As a kind of very low impurity content, polymer vials can meet strict packaging and medical device requirements and provide a safe storage environment for this type of drugs.

How polymer vial protects drug safety

Polymer Vial for cell and gene therapies

Cell-based drugs generally need to be stored in a liquid nitrogen environment, and an ultra-low temperature environment can ensure the activity of the drug. Polymer vials have good low temperature resistance and can meet the storage requirements of this type of drugs.

Requirements for COP vials for cell-based drugs

RTU(ready to use) 2ml COP vial


In addition, for drugs that are easily adsorbed on the glass surface, such as protein-based biopharmaceuticals, vaccines, etc., this low protein adsorption characteristic ensures the accuracy of drug dosage. This not only reduces drug waste but also avoids potential risks to patients due to inaccurate dosing.

In addition to the specific drug types mentioned above, other drugs that are prone to oxidation can also benefit from the excellent barrier properties of CZ vials. It can effectively block external oxygen and moisture, extend the shelf life of drugs, and ensure the stability of drugs during storage and use. In short, this kind of packaging can protect the safety of drugs and provide more reliable protection for patients' health.

2024年1月7日星期日

Syringes-the ideal packaging option for pet probiotic paste

 As pet owners, we understand the importance of maintaining the health and well-being of our beloved furry companions. Probiotic paste has emerged as a popular supplement for pets, aiding in digestive health, immune support, and overall wellness. In this article, we will explore the significance of pet probiotic paste packaging, highlighting its role in ensuring product freshness, ease of administration, and optimal health benefits for our pets.


1. Preserving Product Freshness and Potency:
Pet probiotic paste packaging plays a crucial role in protecting the product from air, moisture, and light exposure, which can degrade the probiotic strains' potency. High-quality packaging materials, such as barrier films or foil pouches, create a protective barrier that preserves the paste's freshness and extends its shelf life. This ensures that the probiotics remain viable and effective until the time of administration.

Application steps of pet syringe

disposable paste syringe


2. Convenient and Controlled Dosage:

Pet probiotic paste packaging is designed to provide pet owners with a convenient and controlled dosage system. The packaging often includes measured markings or pre-filled syringes, allowing for accurate dosing based on the pet's size and specific needs. This eliminates the guesswork and ensures that the pet receives the correct amount of probiotics for optimal health benefits.


Five Components of a Pet Syringe

15ml feeding syringe for dog

3. Easy Administration:
Administering supplements to pets can sometimes be challenging, especially when they have a picky palate. Pet probiotic paste packaging addresses this concern by providing easy administration options. The packaging typically includes a nozzle or applicator that allows for direct oral administration or mixing with food. This makes the process hassle-free and more likely to be accepted by even the most finicky eaters.

4. Portability and On-the-Go Use:

Pet probiotic paste packaging is designed with portability in mind, allowing pet owners to conveniently carry and administer the supplement while on the go. The packaging is lightweight, compact, and often resealable, ensuring that the paste remains secure and fresh during travel or outdoor activities. This feature enables pet owners to maintain their pets' probiotic regimen seamlessly, regardless of their location.


Application steps of pet syringe

30ml dial a dose syringe

5. Product Information and Branding:
Pet probiotic paste packaging provides an opportunity for manufacturers to display essential product information and branding elements. This includes details about the probiotic strains, recommended dosage guidelines, storage instructions, and any additional benefits. The packaging also serves as a platform for showcasing the brand's logo, design, and other branding elements, helping pet owners make informed purchasing decisions and fostering brand recognition.

6. Sustainability and Eco-Friendly Packaging:
In recent years, there has been a growing emphasis on sustainable packaging solutions. Pet probiotic paste manufacturers are increasingly adopting eco-friendly packaging materials and practices. This includes using recyclable or biodegradable packaging materials and reducing overall packaging waste. By prioritizing sustainability, manufacturers contribute to the well-being of both pets and the environment.

Conclusion:
Pet probiotic paste packaging plays a vital role in ensuring the freshness, convenience, and effectiveness of the supplement for our furry friends. Its ability to preserve product freshness, provide controlled dosages, and offer easy administration options makes it a valuable tool for pet owners seeking to improve their pets' digestive health and overall well-being. As the demand for pet probiotics continues to grow, packaging innovations and sustainable practices will further enhance the user experience and contribute to the health of our beloved pets.

FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease

 Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy. 

Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S. It is most common in African Americans and, while less prevalent, also affects Hispanic Americans. The primary problem in sickle cell disease is a mutation in hemoglobin, a protein found in red blood cells that delivers oxygen to the body’s tissues. This mutation causes red blood cells to develop a crescent or “sickle” shape. These sickled red blood cells restrict the flow in blood vessels and limit oxygen delivery to the body’s tissues, leading to severe pain and organ damage called vaso-occlusive events (VOEs) or vaso-occlusive crises (VOCs). The recurrence of these events or crises can lead to life-threatening disabilities and/or early death. 

“Sickle cell disease is a rare, debilitating and life-threatening blood disorder with significant unmet need, and we are excited to advance the field especially for individuals whose lives have been severely disrupted by the disease by approving two cell-based gene therapies today,” said Nicole Verdun, M.D., director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research. “Gene therapy holds the promise of delivering more targeted and effective treatments, especially for individuals with rare diseases where the current treatment options are limited.” 

Casgevy, a cell-based gene therapy, is approved for the treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises. Casgevy is the first FDA-approved therapy utilizing CRISPR/Cas9, a type of genome editing technology. Patients’ hematopoietic (blood) stem cells are modified by genome editing using CRISPR/Cas9 technology. 

CRISPR/Cas9 can be directed to cut DNA in targeted areas, enabling the ability to accurately edit (remove, add, or replace) DNA where it was cut. The modified blood stem cells are transplanted back into the patient where they engraft (attach and multiply) within the bone marrow and increase the production of fetal hemoglobin (HbF), a type of hemoglobin that facilitates oxygen delivery. In patients with sickle cell disease, increased levels of HbF prevent the sickling of red blood cells.

Lyfgenia is a cell-based gene therapy. Lyfgenia uses a lentiviral vector (gene delivery vehicle) for genetic modification and is approved for the treatment of patients 12 years of age and older with sickle cell disease and a history of vaso-occlusive events. With Lyfgenia, the patient’s blood stem cells are genetically modified to produce HbAT87Q, a gene-therapy derived hemoglobin that functions similarly to hemoglobin A, which is the normal adult hemoglobin produced in persons not affected by sickle cell disease. Red blood cells containing HbAT87Q have a lower risk of sickling and occluding blood flow. These modified stem cells are then delivered to the patient. 

Both products are made from the patients’ own blood stem cells, which are modified, and are given back as a one-time, single-dose infusion as part of a hematopoietic (blood) stem cell transplant. Prior to treatment, a patients’ own stem cells are collected, and then the patient must undergo myeloablative conditioning (high-dose chemotherapy), a process that removes cells from the bone marrow so they can be replaced with the modified cells in Casgevy and Lyfgenia. Patients who received Casgevy or Lyfgenia will be followed in a long-term study to evaluate each product’s safety and effectiveness. 

“These approvals represent an important medical advance with the use of innovative cell-based gene therapies to target potentially devastating diseases and improve public health,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s actions follow rigorous evaluations of the scientific and clinical data needed to support approval, reflecting the FDA’s commitment to facilitating development of safe and effective treatments for conditions with severe impacts on human health.”


Pharmaceutical packaging CZ vial instead of glass bottle

Crystal Zenith vial


Requirements for COP vials for cell-based drugs

RTU(ready to use) 2ml COP vial


Source from FDA:https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease

2024年1月4日星期四

Application of Crystal Zenith Vial-palivizumab

 As an important biological agent, palivizumab is used to treat a variety of cancers and is widely recognized for its high efficiency and unique efficacy. However, for packaging materials of biologics, how to ensure the stability of the drug is a key issue. As a pharmaceutical plastic bottle made of cyclic olefin polymer, Crystal Zenith Vials provide an ideal solution for the storage and use of palivizumab.



Requirements for COP vials for cell-based drugs

RTU(ready to use) 2ml COP vial


Stable physical properties: The material of this bottle has excellent physical properties and is particularly suitable for packaging biological agents. First of all, its material has good optical transparency, which can clearly observe the appearance and clarity of the drug, which helps to judge the status of the drug. In addition, the material has excellent heat and cold resistance and can withstand temperatures from -196°C to 121°C, ensuring that the effectiveness and potency of the drug are not affected. These physical properties make Crystal Zenith Vials ideal for storing palivizumab.

Gas barrier performance: It has excellent gas barrier performance and can block the effects of oxygen and moisture on drugs. Oxygen and moisture are one of the main factors leading to the failure of biological agents. Therefore, the gas barrier performance of Crystal Zenith Vials can effectively extend the shelf life and stability of palivizumab. Drugs can be effectively extended, thereby ensuring the quality and efficacy of the drug.

Pharmaceutical packaging CZ vial instead of glass bottle

Crystal Zenith vial


Pharmaceutical packaging CZ vial instead of glass bottle

100ml COP injection vial

Chemical inertness: It has excellent chemical inertness and will not interact or dissolve with drugs, thereby maintaining the purity and activity of palivizumab.

Sealing performance: It has reliable sealing performance, effectively preventing drug leakage or contamination. In a high-value biologic like palivizumab, ensuring the drug's seal is critical. The excellent sealing performance of this kind of packaging ensures the safety and stability of palivizumab during storage and transportation.

In short, as a high-quality packaging container, CZ vials play an important role in the storage and use of palivizumab. Its superior physical properties, gas barrier properties, chemical inertness and sealing properties not only meet the needs of drug stability and preservation, but also ensure the safety of patients during the use of drugs.