Posts

Showing posts from June, 2024

Helix and Recursion join forces in quest to crack the AI-driven drug discovery code

Image
  The UK Biobank, with genetic data on half a million individuals, set a benchmark for scale in medical research. It contains whole genome sequencing data for all 500,000 participants, making it the  world’s largest genetic project  to date. A recent collaboration between the San Diego–headquartered clinico-genomics company  Helix   and the Salt Lake City–based biotech   Recursion Pharmaceuticals   aims to go even further. “We could surpass [UK Biobank] probably by the end of 2025,” says Hylton Kalvaria of Helix. The partnership will combine Helix’s growing clinico-genomic dataset with more than 25 petabytes of Recursion’s proprietary biological and chemical data. The world is awash in data. To cite one example, the latest CommonCrawl dataset, encompassing 17 years of website data, totals 377 tebibytes. That’s equivalent to the storage capacity of more than 3 million 128-gigabyte USB flash drives. “There are larger data sources out there,” Kalvaria ack...

Kazakhstan emerging as haven for biomedical research and clinical testing

Image
  Kazakhstan, a country with a rich scientific heritage, is positioning itself as a haven for cutting-edge biomedical research and clinical trials. Its innovative approach hinges on fostering close collaboration between universities and industrial partners. During the Soviet Union era, the Kazakh research landscape diverged from the closed research institute model which enjoyed ample funding but suffered from a critical drawback – a lack of fresh perspectives. “Recognising this limitation, Kazakhstan transitioned to an open university model – a shift which transformed the scientific landscape,” the Minister of Science and Higher Education, Sayasat Nurbek, told Euractiv. Kazakh universities have since become vibrant research platforms, fostering interdisciplinary collaboration and actively welcoming young talent. Industry-university synergy University labs are rising to global innovation challenges, their funding contingent upon successful problem-solving – as Minister Nurbev explai...

Insights into regional medical devices regulatory affairs to reach LATAM

Image
  The Latin American region comprises 20 countries (depending on classification/sources), many of which are categorized as emerging countries with a population that is estimated to have reached 657 million people as of 2024 (CEPAL). The Latin American market, with several local manufacturers, has outstanding world-renowned professionals who are highly trained in using the latest technology, research and development. Therefore, the region shows a strong trend as an import market for high-tech medical equipment and medical devices. These are some of the reasons why the Latin American market represents a region of strategic interest for building alliances with qualified partners who have experience in such markets. Disregarding the regulatory issues may imply significant risks for companies that wish to enter the Latin American market. Choosing a skilled and suitable regulatory partner plays an important role in this enterprise and selecting the right one is critical. Regulatory clear...

Regulatory Affairs

Image
 Regulatory Affairs (RA) is a vital part of the healthcare industry, including pharmaceuticals, medical devices, biotechnology, and cosmetics. It involves ensuring that products comply with all the regulations and laws pertaining to their development, production, and marketing. Here’s a comprehensive overview of what Regulatory Affairs entails: Key Responsibilities Regulatory Strategy Developing regulatory strategies to ensure products meet all necessary legal requirements. Planning and coordinating regulatory submissions to health authorities. Product Development Guiding the development of products to ensure they meet regulatory standards. Advising on clinical trial design and implementation. Regulatory Submissions Preparing and submitting documents such as Investigational New Drug (IND) applications, New Drug Applications (NDA), Marketing Authorization Applications (MAA), and Biologics License Applications (BLA). Handling amendments and responses to health authorities’ queries. C...

Precision Medicine

Image
 Precision medicine is an innovative approach to healthcare that aims to tailor medical treatment to the individual characteristics of each patient. It moves away from the traditional one-size-fits-all method to a more customized strategy based on a patient’s genetic makeup, environment, and lifestyle. This personalized approach has the potential to improve the effectiveness of treatments and reduce adverse effects. Key Aspects of Precision Medicine: Genomics and Genetics: Analysis of a patient’s genetic code can reveal variations that may contribute to certain diseases. Understanding these genetic factors can help in predicting disease risk and tailoring preventive strategies. Pharmacogenomics, a branch of precision medicine, examines how genes affect a person’s response to drugs. Big Data and Bioinformatics: The integration and analysis of large datasets from various sources (e.g., electronic health records, genomic databases) are crucial. Advanced algorithms and machine learning...

Pharmaceutical Manufacturing

Image
https://toppharmaceutical.org/ Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. It involves a series of unit operations to produce a pharmaceutical product from raw materials. Here are the key steps and aspects involved in pharmaceutical manufacturing: Key Steps in Pharmaceutical Manufacturing: Research and Development (R&D): Drug Discovery: Identifying potential drug candidates through screening and testing. Preclinical Testing: Evaluating the safety and efficacy of the drug in lab and animal studies. Clinical Trials: Conducting studies on humans in multiple phases to ensure safety, efficacy, and dosage. Formulation Development: Formulation: Developing the physical form of the drug (tablet, capsule, injection, etc.). Excipients: Selecting non-active ingredients that enhance the drug's stability, bioavailability, and patient compliance. Raw Material Sourcing: Procuring high-quality active pharmac...

Biologics

Image
  Biologics, also known as biological drugs or biopharmaceuticals, are a class of medications derived from living organisms, such as cells, tissues, or proteins. These drugs are used to treat various diseases and medical conditions, often targeting complex diseases that are difficult to treat with traditional chemical drugs. Here’s an overview of biologics: Types of Biologics Monoclonal Antibodies : Engineered antibodies designed to target specific antigens on cells. Used in treatments for cancers, autoimmune diseases, and infectious diseases. Vaccines : Biological preparations that provide immunity against specific infectious diseases. Include live attenuated, inactivated, subunit, and mRNA vaccines. Recombinant Proteins : Proteins produced through recombinant DNA technology. Examples include insulin, growth hormones, and clotting factors. Cell and Gene Therapies : Treatments involving the transplantation of cells or genetic material to treat or prevent disease. Includes CAR-T cel...

Formulation Science

Image
 Formulation science is a multidisciplinary field that focuses on the design, development, and optimization of complex mixtures, typically in the form of products such as pharmaceuticals, cosmetics, foods, and household goods. The primary goal of formulation science is to combine various ingredients in specific proportions to achieve desired characteristics and performance attributes, such as stability, efficacy, texture, taste, and appearance. Key Aspects of Formulation Science Ingredient Selection and Compatibility: Understanding the chemical and physical properties of individual ingredients. Ensuring compatibility among ingredients to prevent adverse reactions. Stability and Shelf Life: Developing formulations that maintain their efficacy and safety over time. Conducting stability testing under various environmental conditions. Delivery Systems: Designing systems for effective delivery of active ingredients to the desired site of action. Examples include encapsulation in liposom...

Pharmaceutical Manufacturing

Image
 Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. It involves a series of steps to ensure that the medications produced are of high quality, safe, and effective for patient use. The process encompasses several critical stages, including: Research and Development (R&D): Discovery: Identification of new chemical entities or biological products through research. Preclinical Testing: Laboratory and animal testing to evaluate safety and efficacy. Clinical Trials: Testing in human subjects to confirm safety and effectiveness. Formulation Development: Drug Formulation: Designing the composition of the drug, including active ingredients and excipients (inactive ingredients). Dosage Form Design: Creating the final product form (e.g., tablets, capsules, injectables). Manufacturing Process: Active Pharmaceutical Ingredient (API) Production: Chemical synthesis or biological processes to produce t...

Drug delivery systems

Image
 Drug delivery systems refer to technologies and approaches used to deliver pharmaceutical compounds to specific targeted sites within the body in a controlled manner. These systems are designed to improve the efficacy and safety of drugs by ensuring optimal drug concentration at the target site while minimizing side effects and reducing dosing frequency. There are several types of drug delivery systems, each with its own advantages and applications: Oral Drug Delivery : The most common route for drug administration, involving tablets, capsules, or liquids that release drugs in the gastrointestinal tract. Injectable Drug Delivery : Includes intravenous (IV), intramuscular (IM), and subcutaneous (SC) injections, allowing for rapid drug delivery and precise dosing. Transdermal Drug Delivery : Delivers drugs through the skin via patches or topical formulations, providing sustained release and avoiding first-pass metabolism. Inhalation Drug Delivery : Delivers drugs directly to the lun...

Pharmacology

Image
 Pharmacology is the branch of medicine and biology that studies the effects, mechanisms, and uses of drugs. It encompasses a broad range of topics related to the interaction between drugs and biological systems. Here are some key areas within pharmacology: 1. Pharmacodynamics This area focuses on the effects of drugs on the body. It studies how drugs work at the cellular and molecular levels, their mechanisms of action, and the relationship between drug concentration and effect. 2. Pharmacokinetics Pharmacokinetics deals with the movement of drugs within the body over time. It includes the processes of absorption, distribution, metabolism, and excretion (ADME). 3. Pharmacotherapeutics This branch examines the use of drugs to treat diseases. It involves the selection of the appropriate drug, dosage, and duration of treatment to achieve optimal therapeutic outcomes. 4. Toxicology Toxicology studies the harmful effects of drugs and other chemicals. It assesses the risks and mechanism...

Using Advanced Algorithms to Solve Formulation Challenges

Image
  Artificial intelligence (AI) and machine learning (ML) in the biopharmaceutical industry have been widely applied across drug discovery and clinical development efforts. These technologies also have potential to impact many other aspects of drug development and manufacturing. Their use in formulation development has been growing in recent years due to the potential for AI/ML to streamline and accelerate this process, particularly for challenging drug substances such as those that suffer from poor solubility and bioavailability (1). The traditional approach to formulation development involves extensive, time-consuming, and costly physical experimentation and screening, both in vitro and in vivo, to identify optimal formulations. Leveraging AI/ML algorithms allows for identification of formulations with the greatest likelihood of success, reducing the time and resources needed for physical evaluation. These technologies can also uncover new materials with attractive excipient prope...