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information about side effects over several months or years. While larger than earlier phases, phase II still doesn’t demonstrate overall safety; in Phase III, randomized and blind testing occurs in large groups of people. The focus is on confirming effectiveness, monitoring side effects, and comparing the new treatment to existing ones. Data collected during this[…]

IOPC – Conference abstracts

Aurélien Thomen, CAMECA’s NanoSIMS commercial speech Advances in Subcellular measurements of oligonucleotides and peptides with the CAMECA NanoSIMS There is increasing interest in moving away from animal testing and moving towards human organoids. However, oligonucleotides are difficult to measure in vitro with conventional mass spectrometry. This is partly due to that fact that these molecules[…]

Building your bioassay data package

major delays at later stages as well as ensure manufacturing consistency. Immunogenicity risk: assays in this group will identify any potential immune responses against biotherapeutics. Immunogenicity testing is absolutely essential because immune responses against a therapeutic can range from antibody responses with no apparent clinical manifestations to life-threatening and catastrophic reactions.   Next,[…]

Nucleic acid therapeutics through discovery and manufacturing to digitalization

the years, the regulatory landscape has evolved to accommodate the unique characteristics of nucleic acid therapies. However, navigating this evolving regulatory landscape remains complex, requiring rigorous preclinical testing, robust clinical trials, and close collaboration between industry stakeholders and regulatory authorities. Despite the challenges, as of 2023, 18 nucleic acid therapies have made it to[…]

Towards next generation polymers for Gene-Delivery applications

the need of repeated administration in gene-based therapies, reinforces the importance of biodegradability for the design of gene-delivery vectors. Nevertheless, there is a lack of standardized biodegradation testing methods (5), especially for polymers characterization, which could reasonably rely on libraries of existing biodegradation studies of polymers in a near future. Both naturally-derived and synthetic polymers[…]


techniques.     Leak Detection Capabilities Also at ACHEMA, Antares Vision Group will emphasize its prowess in leak detection. For example, the company’s container closure integrity testing (CCIT) plays a critical role in maintaining the sterility and stability of sterile products, and is essential for preserving critical headspace gas conditions – including those common[…]


based on counterparty type, emphasizing direct collaboration with a network of entrepreneurs or advisors. Galvain focuses on projecting good faith and transparency, with advisors involved for valuation testing. Fitzharris emphasizes collaboration and value creation, leveraging due diligence to address potential obstacles early in the process. Ledbetter stresses the value of transparency and communication in[…]

Flexibility and education keys to overcoming biosimilar barriers

$74 billion by 2030 (2).   The first biosimilar was approved in Europe in 2006 and, while uptake and savings did not initially meet expectations, manufacturing and testing of biosimilars has improved over time. What seemed impossible in the past – for example, biosimilar monoclonal antibodies – is now considered fairly mainstream. After a[…]

A process digital twin framework for biopharmaceutical manufacturing

ensure consistent product quality throughout manufacturing processes (1, 2). A parallel effort is echoed by the European Medicines Agency (EMA), which has issued recommendations on real-time release testing (3). As a result, the biopharmaceutical industry is placing significant emphasis on the development of process monitoring and automated process control strategies. One notable approach, proposed by[…]

PAT – Advancing innovation, efficiency and control in biopharma manufacturing

and encourage the implementation of more efficient approaches in pharmaceutical development, manufacturing and quality assurance (1). The aim is to build quality into the products instead of testing the quality of the product at the end of the process, thus introducing the principle of Quality by Design (QbD) – a science-driven, risk-based approach supported also[…]

Artificial intelligence and toxicology/ risk assessment: the unknown future

replace of experimental approach with alternative methods (at least for some toxicological end-points) is not expected soon (see 1). This means that companies will continue to pay testing labs to get their own studies. The results of such studies are not public but covered by confidentiality for a number of years (12 under the REACH[…]

The impact of flow chemistry in the drug discovery process

new medicines for the treatment of diseases is not a simple task. Researchers often create new active compounds from scratch, through a laborious process involving synthesising and testing thousands of compounds with the aim of finding those suitable to be tested in human beings (1). In this context, medicinal chemistry is an interdisciplinary science at[…]

Solvias to Build Biologics and Cell & Gene Therapy Testing Center in Research Triangle Park

KAISERAUGST, Switzerland, May 6, 2024 – Solvias announced today that it is expanding its global network of laboratory testing centers with a new biotech site in Research Triangle Park, N.C. It is the company’s latest investment to expand its analytical testing services supporting life science organizations with the growing number of cell and gene therapies[…]

FERRING PHARMACEUTICALS & SK PHARMTECO – Ferring Pharmaceuticals and SK pharmteco enter into commercial gene therapy manufacturing deal

Adstiladrin® (nadofaragene firadenovec-vncg) for ensuring long-term future supply. Following technology transfer, SK pharmteco, a contract development manufacturing organisation (CDMO), will be qualified as another source for manufacturing, testing, and release of the medicine, subject to regulatory approval by the U.S. Food and Drug Administration (FDA). Adstiladrin® was approved by the FDA in December 2022 for[…]

Intertek Launches Pioneering Digital Platform iCare in India

in Türkiye last November.   iCare is an innovative one-stop digital portal providing textile manufacturers with a pioneering solution that enables seamless management and monitoring of their testing processes from start to finish. Harnessing Intertek’s unique Science-based Customer Excellence Advantage, iCare addresses the long-standing challenges of transparency and traceability in the processing and testing of[…]

SYMRISE – Symrise launches Savelite® HB, a highly versatile multifunctional ingredient for protect

revolutionary SymSave® H, sees Symrise broaden its formulator toolbox. While enabling the formulation of safer products, Savelite® HB acts as an efficient moisturizer. in vivo corneometer testing show an increase of 10.9% after two weeks. It fully respects the skin microbiome. Further, it can help stabilize emulsions by reducing oil droplet size. The ingredient[…]

HELIOSCREEN – Change of identity – HelioScreen becomes WENEOS

which is to enable companies of all sizes to ensure reliable assessment of sun protection, in accordance with international standards. Thus, we have moved from a testing laboratory to a complete and unified center of expertise, bringing together all the services and products relating to the evaluation of sun protection using alternative methods. […]

Lunch & Learn – The Future of the Cosmetic Industry: Challenges & Opportunities

challenges arise from retailers, consumers, and NGOs urging the removal of non-easily substitutable ingredients, including preservatives, colorants, and chelating agents. A notable obstacle is the constraint on testing , especially as the industry grapples with innovation amidst bans on animal testing and the absence of adequate alternatives. There’s an industry-wide push towards sustainability, seeking to[…]

Positive Phase 1/2 Clinical Trial Data for an Investigational Gene Therapy for Genetic Hearing Loss

a dose of 4.1E11 total vector genomes. “Children with OTOF-mediated hearing loss are often born with profound hearing loss, yet only a small fraction have undergone genetic testing to receive a definitive diagnosis,” said Dr. Oliver Haag, pediatric otolaryngologist, Head of Otolaryngology at Sant Joan de Deu Hospital in Barcelona, and an investigator in Akouos’s[…]

AURIGENE – Aurigene Pharmaceutical Services Ltd. introduces Aurigene.AI™, an artificial intelligence (AI) and machine learning (ML) assisted drug discovery platform

  AI is an end-to-end solution for small molecule drug discovery combining AI and ML capabilities with Aurigene’s core expertise in synthesizing and testing the molecules in vitro and in vivo. The platform consists of a meticulously curated database that serves as training data. The modular platform allows users flexibility in selecting suitable AI models[…]

Cambrex Announces Sale of Drug Product Business Unit

a strategic decision to focus on core areas of growth and investment,” said Cambrex CEO Thomas Loewald. “Looking forward, Cambrex will prioritize our drug substance and analytical testing portfolios, enabling our customers to develop and deliver therapeutic solutions for patients around the world.” Cambrex recently expanded its portfolio of specialized solutions for pharmaceutical development and[…]

Nice drug if you can get it. Can’t get it if you try?* On the current scarcity of semaglutide (et alia).

easily found on the internet, but here are a few pointers and notes.   Belgium’s Health Minister Sparks Debate Over Ozempic Prescription Limitations. Belgium’s Ozempic Controversy: Testing the Bounds of Therapeutic Freedom ( Belgium bans use of Ozempic for weight loss until summer. Belgium bans use of Ozempic for weight loss until summer |[…]

Cosmetica Italia a Cosmoprof Bologna 2024

Servizi (blocco D, 1° piano); qui troverà spazio anche un’area dedicata a Cosmetica Italia Servizi, società di servizi dell’Associazione che offre supporto professionale, formazione e attività di testing alle aziende. All’interno della lounge di Cosmetica Italia, un’apposita area convegnistica ospiterà nel corso dei quattro giorni della manifestazione una serie di incontri utili ad approfondire temi[…]

REACH REGULATION UPDATE 2024: What is expected

scientists presented a road map addressed to practice an animal experimentation that will take into account both the data quality and the welfare of animals used in testing . Their approach is still known as the 3R principles where 3Rs means:   Replacement: “any scientific method employing non sentient material which may, in the history[…]

Panel discussion on AI IN PHARMA SUPPLY CHAIN

of treatment results, inventory, and supply chain management, as well as many additional areas (4).   Slowly but steadily, the pharma sector is also becoming the next testing ground for companies looking to use AI to help digitalize and boost their global supply chains. For this special feature, we have invited 20 expert panelists to[…]

Cholangiocarcinoma: new organ-on-chip aims at accelerating research and personalized medicine

better mimics what we observe in patients. At the same time, it will help advancing precision medicine, since it could be potentially used as a personalized drug- testingplatform, helping predict patients’ response to therapies,” say Ana Lleo and Marco Rasponi. The study was funded by AIRC – the Italian Foundation for Cancer Research, and[…]

New NIH-funded center could soon reduce the need for pharmaceutical trials on animals

Jr. Professor of Biomedical Engineering “Drug discovery is moving into an era where fewer animals are used to test for safety and efficacy.”   McGrath says that testing drugs on µSiM chips can lead to fewer animal trials. And because researchers will be studying the drugs’ effects on human cells, they may also help overcome[…]

Prevalence of allergic contact dermatitis in children with and without atopic dermatitis: A multicenter retrospective case-control study

dermatitis and atopic dermatitis (AD) have similar clinical presentations and are characterized by spongiotic dermatitis on skin biopsy, many children with AD are not referred for patch testing and allergic contact dermatitis is underdiagnosed. A study published in the Journal of the American Academy of Dermatology aim to analyse the relationship between these two pathological[…]

PCHi 2024 Set to Redefine Industry Standards with Innovative Feature Areas

the dedicated efforts of various exhibitors toward sustainable development, including a forum for exhibitors to detail how they’ve incorporated sustainability in their products, services, and business practices. Testing and Laboratory Zone: In collaboration with the Shanghai Society of Toxicology, the area will feature over 60 products and technologies designed to address regulatory and end-user expectations[…]

New efficacy testing requirements for biocidal products

indicative efficacy must be proven for active substances the proof of biocidal efficacy is a more detailed essential step in the authorization of biocidal products. The efficacy testing of biocidal products has been traditionally undertaken for a number of reasons such as supporting label claims, comparative testing against competitor products, new product development, compliance with[…]

REACH regulation update 2024: what is expected

identify special polymer classes or families that can be subjected to REACH registration and, on the other side, to determine the criteria for the Registration (tonnage levels, testing and so on). The European Commission has already stated its commitment to publish a proposal by 2021 to bring “at least some” polymers under REACH registration requirement.[…]

Data integrity in GxP relevant areas has been a hot topic in the pharmaceutical sector in recent years

configurable software and electronic data retention are employed (such as certain pH meters, balances, and thermometers), controls should be established to prevent adverse data manipulation and repeated testing to achieve desired results. While technical controls should be prioritized, additional procedural or administrative controls should be implemented to manage aspects of computerized system control in[…]

Assuring quality of oligonucleotide APIs and DPs

considered “big small molecules” and are expected to meet the ICH guidelines for New Chemical Entities (small molecules) (1).   When characterizing your oligonucleotides, the expectations for testing are not that clear, especially when it comes to related substances. Related substances in oligonucleotides can arise from a variety of sources and are typically divided into[…]

The importance of investments to tackle the future challenges

and patient demand for safer products, pharmaceutical companies must adopt rigorous quality control measures, applying appropriate and foremost analytical methods. This translates into higher standards for manufacturing, testing, and distribution processes, guaranteeing that patients receive treatments that meet the most stringent criteria. Investments in technology are equally paramount. The pharmaceutical industry, with its[…]

ECHA identifies research needs for regulating hazardous chemicals

areas where research is needed to protect people and the environment from hazardous chemicals. It also highlights where new methods, that support the shift away from animal testing , are needed. Helsinki, 15 November 2023 – To further improve chemical safety in the EU, scientific research needs to deliver data that is relevant to regulating[…]

Classic hygiene weaknesses in the production of cosmetics

hygiene, and the selection of raw materials. Consequences of hygiene deficiencies include complaints, health risks, product recalls and economic losses. Recommendations include regular cleaning, disinfection and microbiological testing, as well as careful evaluation of raw materials. A systematic approach, inspections and open communication are essential for successful hygiene management. Environmental monitoring complements these measures.[…]

Odour control efficacy of a carpet cleaning home care product

smell more than fifteen years ago, as an environmental engineer involved in odour impact assessment projects. Rita successively focussed her career in the field of consumer goods testing through sensory and molecular analysis, as well as consumer studies. Since 2019, she is a senior consultant on odour testing of products and materials at Olfasense. Alina[…]

Microplastics: a perspective on the regulatory landscape for the cleaning products industry

topic that consequently led to the development of standard methods to assess biodegradation that further framed regulations. In 1973, Sturm published pioneering work in the field of testing for biodegradation of substances in aqueous media (11). This work was further refined and expanded by research conducted by numerous investigators that eventually resulted in the development[…]