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Additionally, the authors highlighted that a greater number of pharmaceutical and biotechnology contract manufacturing organisations (CMOs) has broadened the opportunities for providers of pyrogen testing services. This was attributed to their “highly sensitive and specific” testing capabilities.
To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. The result is efficient, cost-effective and high-quality (bio)pharmaceuticalproduction. principles.
2,3 Clinical implementation of CAR T-cell technology requires a reproducible T-cell manufacturing platform, which necessitates effective gene-transfer tools and T-cell culture conditions. Due to shipping and manufacturing requirements, the time from a patient being included in the CAR T programme to receiving therapy can be several weeks.
From the examination of raw materials through the release of the finished packaged product, Quality Control Authorities like Central Drugs Standard Control Organisation in India established under the Drugs & Cosmetics Act, 1940. They play a crucial role in assuring the efficacy and safety of products given to patients.
Automated solutions, especially those aided by artificial intelligence (AI) , can enhance productsafety, the report noted. Pharmaceuticalsproduction lines are challenged by customised dosages and products such as pre-filled syringes. Popularity of injectables has also increased the focus on sterility.
However, for the pharmaceutical industry, the challenge is not as simple as just switching materials. An industry that is among the world’s biggest polluters is caught in a balancing act between satisfying the health and safety demands of industry regulators and meeting the needs of modern eco-conscious consumers.
Prospects of the ampoules packaging market On the other hand, advancements in ampoule packaging, as well as sustainability measures and manufacturing innovations such as automation and robotics, were highlighted as promising contributing factors for growth of the market.
According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceuticalproduct recalls and accounted for 45.3
To appreciate the scope of the challenge facing the pharmaceutical market, as well as patients across the globe, we must understand that there are two distinct threats – ‘counterfeit’ and ‘falsified’ medicines. There is also the challenge of falsified medicines – the fake, unauthorised medical products that make their way into the market.
Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. First has been the cost”, says Franck Germain, VP marketing at Linxens, a global technology company that manufactures electronic components for security and identification, including RFID antennas and inlays.
Freeze drying is a crucial technique to prolong the shelf life of pharmaceuticalproducts. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.
This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Guaranteeing resilience in vaccine manufacturing The use of foreign materials that require removal before injection are also impracticable.
Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. What is the biggest impact of having compromised data when working with regulatory bodies in the pharmaceutical industry?
Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines.
Applying AI to GVDs Amassing comprehensive productand market-related data, GVDs demonstrate the value of a pharmaceuticalproduct to various stakeholders, including payers, healthcare providers, and regulatory bodies. It leveraged experts input at key points in the process, to assess and validate the work.
Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceuticalproducts. The post Leading commercial packaging companies in contract marketing appeared first on Pharmaceutical Technology.
The pharmaceutical industry is one of the most heavily regulated sectors due to the direct impact of its products on public health and safety. Several factors contribute to the stringent regulatory environment: Patient Safety: Ensuring that the pharmaceuticalproducts are safe and effective is a crucial aspect.
More convenience and safety? On April 18, 2002, the Pharmaceutical Research and Manufacturers of America (PhRMA) adopted a new marketing code to govern the pharmaceutical industry’s relationships with physicians and other health care professionals…” – AMA Journal of Ethics. What’s not to love?
Given China’s status as the world’s second most populous nation and an economic powerhouse, it represents both a monumental market opportunity and a dynamic arena of challenges for pharmaceuticalproducts. Regulatory body – NMPA : all pharmaceuticalproducts sold in the Chinese market need to be granted market authorization by NMPA.
Since then, there have been major advances in this field, including monoclonal antibodies (MAbs), other recombinant proteins, antibody drug conjugates (ADCs) and advanced therapy medicinal products (ATMPs), and considerably better understanding of product characteristics. EMA/CHMP/ICH/214732/2007. November 2012. 4 March 2020.
Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.
Nitrosamines have garnered significant attention from the pharmaceutical industry due to their detection in commonly prescribed medications for conditions like type 2 diabetes, high blood pressure, and heartburn. [1] However, this regulatory ban does not impact active pharmaceutical ingredients (APIs).
Each strain was selected to take into account: the variability of environmental and human strains in a pharmaceuticalproduction environment strains known for their particular growth conditions, such as growth temperature, invasiveness, growth difficulties, etc (eg, Cladosporium , specific moulds, corynebacteria , Bacillus , etc).
The US Food and Drug Administration (FDA) has sent a warning letter to KVK-Techs drug manufacturing facility following an inspection in April 2019. The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.
government to manufacture 100 million doses of its investigational COVID-19 vaccine. But what does that billion dollars buy as far as approving the product for market? Under NO circumstances should any pharmaceuticalproduct be allowed into the market without complete and thorough testing.
This process is used to manufacturepharmaceuticalproducts with low molecular weights in large batches within a short timescale. While this is exciting news for the pharmaceutical industry, chemical synthesis presents a number of challenges when it comes to running a manufacturing plant.
A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceuticalproducts. The evolution of CCIT. Free Webinar.
It is important that preservatives do not compromise the quality or performance of a formulation or product but simply protect it against microbial proliferation throughout the entirety of the product’smanufacture, shelf life, and usage. Other important points to consider include safety and quality. Free Whitepaper.
Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The document contains detailed information on the providers and their product offerings, alongside contact details to aid your purchasing or hiring decision.
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