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EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products have come into force. Anna Cluet of Rephine delves into the challenges faced by certain manufacturers when implementing effective Contamination Control Strategies and practical Quality Risk Management, sharing valuable insights and tips for addressing the issues.
In August, the revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products came into force, with implications for contamination control strategies and, by extension, for plant facilities, equipment, manufacturing processes and Quality systems. The updated requirements are designed to increase confidence in these products. Now that they are live, the expectations of auditors have adapted accordingly which will have a…
As a recruiter or hiring manager in the life science industry, it’s crucial to remain objective and impartial during the hiring process to build a diverse and inclusive workforce that brings together a wide range of perspectives and experiences. Biases in the hiring process, whether conscious or not, all too often lead to talented candidates being overlooked, and missing out on opportunities that should be equal for all.
As a recruiter or hiring manager in the life science industry, it’s crucial to remain objective and impartial during the hiring process to build a diverse and inclusive workforce that brings together a wide range of perspectives and experiences. Biases in the hiring process, whether conscious or not, all too often lead to talented candidates being overlooked, and missing ou…
This comprehensive guide to healthcare covers three main aspects: mental health, physical health, and diseases. Mental health, often unseen, is about our cognitive, behavioral, and emotional wellbeing. It’s crucial at every stage of life and affects how we handle stress, relate to others, and make decisions. Common mental health disorders include depression, anxiety disorders, schizophrenia, eating disorders, and addictive behaviors. Physical health is the more visible aspect of healthcare. It involves maintaining a healthy body through good nutrition, regular exercise, and a healthy lifestyle. Common physical health conditions include heart disease, stroke, cancer, diabetes, and respiratory diseases. Diseases pose significant challenges in healthcare. They can be acute or chronic and can affect both mental and physical health.
Biotechnologists work in a variety of settings, including pharmaceutical companies, research laboratories, agriculture companies, and government agencies. In this article, we dive deeper into the role of a Biotechnologist, focusing on the main benefits of this career path and the essential requirements needed to succeed in the field.
A Biotechnologist is a scientist who uses living cells, organisms, and bioprocesses to create new products and technologies that benefit society. Some of their responsibilities include researching and developing new drugs, creating genetically modified crops, studying the mechanisms and functions of living organisms, and using biotechnology to solve environmental issues. Biotechnologists work in a variety of settings, including pharmaceutical companies, researc…
Buffer solutions play an important role in most biopharmaceutical processes, such as purification, isolation, filtration, protein capturing, chromatographic filtration, crystallization steps, and reactions. Being a vital formulation of drug development, buffers are also used to control pH and maintain the stability of drugs in their final form. Buffer manufacturing requires space, higher titers, resources, and a lean operation system, which adds to the cost of drug development. Conventional buffer manufacturing is tedious and consumes time. To overcome the challenges, pharmaceutical industries are either looking for advanced tech-driven buffer manufacturing or outsourcing buffers from third-party vendors.
Recently, the trend of outsourcing buffer manufacturing system has been adopted by ph…
Cell cytometry is a powerful technology that allows rapid multi-parametric analysis of single cells inside the solution. It utilizes fluorescent light signals that pass through the cell suspension and read through detectors such as photomultiplier tubes and photodiodes. The signals are then converted into electronic signals and transferred on the computer devices to create standard written format data files. This novel technology has enabled scientists to do clinical research more efficiently. Cell cytometry plays a crucial role in determining the immune system response, particularly during cancer immunotherapy and drug development.
In both Allogeneic and Autologous cell therapy products, cell cytometry helps to evaluate key drug parameters that help to understand the effectiveness of the…
Most biological agents enter the body directly without passing through the gastrointestinal tract, so in addition to biological activity, relevant authorities have very strict requirements on impurities in drugs. Among them, the host cells residual DNA has always been the focus of regulatory agencies because of its special potential safety risks.
Most biological agents enter the body directly without passing through the gastrointestinal tract, so in addition to biological activity, relevant authorities have very strict requirements on impurities in drugs. Among them, the host cells residual DNA has always been the focus of regulatory agencies because of its special potential safety risks.   Although recombinant protein drugs, antibody drugs, vaccines and other produ…
Car-t cell therapy involves genetically engineering T cells isolated from patients or allogeneic donors to express chimeric antigen receptors (CAR) that specifically recognize and kill tumor cells.
What is CAR T-cell therapy? Car-t cell therapy involves genetically engineering T cells isolated from patients or allogeneic donors to express chimeric antigen receptors (CAR) that specifically recognize and kill tumor cells.   As a "living" drug, CAR-T therapy is very different from traditional drugs. It is a new type of precision targeted therapy for the treatment of tumors. Compared with traditional chemotherapy and hematopoietic stem cell transplantation, it is more precise in killing tumor cells and significantly reduces toxic side effects while improving efficacy.   Cytokines in C…
Fc fusion protein (Fc-Fusion) has a complex and diverse molecular structure, and may contain glycosylation modification sites at amino acid 297 of its Fc fragment and the Fab region of some molecules. Moreover, its biological ligands are structurally diverse, and their glycosylation modifications may also be complex, usually involving multiple N-glycan and O-glycan sites and a large number of sialic acids.
Fc fusion protein (Fc-Fusion) has a complex and diverse molecular structure, and may contain glycosylation modification sites at amino acid 297 of its Fc fragment and the Fab region of some molecules. Moreover, its biological ligands are structurally diverse, and their glycosylation modifications may also be complex, usually involving multiple N-glycan and O-glycan sites&nb…
Phosphatidylglycerol (PG) is a type of phospholipid, a class of molecules that are crucial components of biological membranes. These membranes are found in cells and organelles, and they serve as barriers that separate the interior of these structures from the external environment.
What is Phosphatidylglycerol? Phosphatidylglycerol (PG) is a type of phospholipid, a class of molecules that are crucial components of biological membranes. These membranes are found in cells and organelles, and they serve as barriers that separate the interior of these structures from the external environment.   What are The Sources of Phosphatidylglycerol? Phosphatidylglycerol (PG) is found in a variety of organisms, and its sources can be categorized based on the different biological systems in which it i…
The antibiotics market, valued at a staggering USD 36 billion in 2023, stands as a critical pillar in global healthcare, combating bacterial infections—one of the leading causes of death worldwide. However, as multi-drug resistant bacteria infections loom larger, the arsenal of antibiotics faces depletion, with shortages in key players like penicillin and amoxicillin intensifying the challenge.
Traditional discovery methods, strained by these shortages and hindered by the rise of antimicrobial resistance, are struggling to keep pace. In this tumultuous landscape, the emergence of Artificial Intelligence (AI) becomes a beacon of hope, offering transformative potential. This article delves into the intricacies of the antibiotics market, exploring challenges posed by multi-drug resistant bacte…
In the intricate landscape of bioprocessing, the precision of buffer manufacturing emerges as a critical factor shaping the success of pharmaceutical and biotechnological endeavors. As we navigate the digital age, the art and science of buffer production have evolved significantly, becoming a fascinating journey marked by innovation and sophistication.
The importance of precise buffer design in bioprocessing cannot be overstated. Buffers, aqueous solutions tasked with controlling pH in drug manufacturing processes, serve as the unsung heroes, ensuring the stability of biologics and small molecules throughout production and in their final forms. This becomes particularly pertinent in an era where the global buffer preparation market is projected to grow at a notable CAGR of around 5.9% until…
The pharmaceutical industry is a huge contributor to climate change - what changes can help it go green at last?
The pharmaceutical industry is currently responsible for over four per cent of global carbon emissions and this figure is on track to grow in the coming years. The UK Government has committed in legislation to reach net-zero carbon emissions by 2050, but achieving this goal could hinge on whether or not the industry finds a way to go green. Here Simon Farnfield, event director at Lab Innovations, discusses the changes that are allowing the pharmaceutical industry to go green at last.  Despite being an emissions-producing juggernaut, the pharmaceutical industry rarely faces the same level of scrutiny as other industries because of its role in providing crucial healthcare solu…
Chromatography, a sophisticated analytical technique, plays a pivotal role in various industries, offering a powerful means of separating and analyzing complex mixtures. Derived from the Greek words "chroma" (color) and "grapho" (to write), chromatography enables the detailed examination of compounds within a sample, allowing for precise identification and quantification. Its significance extends across pharmaceuticals, biotechnology, environmental science, food and beverages, and more.
The roots of chromatography can be traced back to the early 20th century when Mikhail Tswett introduced the concept of liquid-phase chromatography. Over the years, chromatography techniques have evolved significantly, driven by technological advancements and a growing demand for more sophisticated analytical…
Ifosfamide is a parenterally administered alkylating agent similar to cyclophosphamide. The chemical name of it is 3-(2-chloroethyl)-2-[(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphospholane-2-oxide and used for a variety of cancers.
Introduction Ifosfamide is a parenterally administered alkylating agent similar to cyclophosphamide. The chemical name of it is 3-(2-chloroethyl)-2-[(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphospholane-2-oxide and used for a variety of cancers. The structure is shown in fig. 1. Fig. 1 Structure of ifosfamide Application in the treatment of cancer Ifosfamide has been effectively employed in the treatment of multiple cancers, including testicular cancer, soft tissue sarcoma, osteosarcoma, bladder cancer, small cell lung cancer, non-Hodgkin lymphoma, Ho…
what exactly is Generative AI, how has it evolved, and what role can it play in clinical research? Let’s delve deeper!
Introduction In the early years, your phone’s predictive text made you wonder, then came Gmail’s Smart Reply feature that utilizes machine learning to provide one-sentence responses. Since then we have come a long way, all thanks to Generative AI or GenAI. This technology is now capable of creating art, composing coherent paragraphs, writing code, and even assisting scientists in clinical research. But what exactly is Generative AI, how has it evolved, and what role can it play in clinical research? Let’s delve deeper! What is Generative AI? Generative AI, in simple terms, is a type of artificial intelligence that can create things on its own, like writing text, generating…
Including figures and images in clinical research enables researchers to illustrate their findings in a clear, effective, and engaging way. Despite their importance, it can be difficult to manually check images for accuracy — introducing the risk of integrity issues. Here Dr. Dror Kolodkin-Gal, founder of image integrity software developer Proofiger, explains best practice for image checking in clinical research.
Including figures and images in clinical research enables researchers to illustrate their findings in a clear, effective, and engaging way. Despite their importance, it can be difficult to manually check images for accuracy — introducing the risk of integrity issues. Here Dr. Dror Kolodkin-Gal, founder of image integrity software developer Proofiger, explains best practice for imag…
83% of employees feel that recognition affects their motivation to succeed at work, and 77.9% feel they would be more productive if they were recognised more frequently. As well as improving overall productivity, employee recognition plays a crucial role in fostering a positive work culture, boosting employee morale, and creating a supportive work environment.
83% of employees feel that recognition affects their motivation to succeed at work, and 77.9% feel they would be more productive if they were recognised more frequently. As well as improving overall productivity, employee recognition plays a crucial role in fostering a positive work culture, boosting employee morale, and creating a supportive work environment. In this article, we explore 9 ways you can enhance your employee recognitio…
ADMET (absorption, distribution, metabolism, excretion and toxicity) pharmacokinetic prediction method is a very important approach in drug design and drug screening.
What Is MADMET Prediction? ADMET (absorption, distribution, metabolism, excretion and toxicity) pharmacokinetic prediction method is a very important approach in drug design and drug screening. Early studies on the properties of drugs in ADMET mainly focused on human-derived or humanized tissue functional proteins as drug targets. Combined with in vitro research techniques and computer simulation, scientists study the interaction between drugs and in vivo biophysical and biochemical barrier factors. Alfa Chemistry can predict ADME parameters and pharmacokinetic properties by calculating the physical and chemical…
The application of ethers in pharmaceuticals has been a topic of keen interest within the wider industry. Ethers, such as aryl and alkyl ethers, are found in various pharmaceutical compounds because of their unique physicochemical properties.
What is Ether? Ether is a product in which the hydrogen in the hydroxyl group of an alcohol or phenol is replaced by a hydrocarbon group. The general formula is R-O-R', and R and R' can represent the same or different groups. Ethers that are the same are called symmetric ethers, also known as simple ethers or monoethers; Ethers that are different from each other are called asymmetric ethers. If R and R 'are carbon atoms at both ends of an organic group, they are called cyclic ethers, such as ethylene oxide. Most ethers are colorless liquids at roo…