Asklepios BioPharmaceutical (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer, has announced initiation of recruitment to REGENERATE-PD, a Phase 2 clinical study assessing efficacy and safety of AB-1005, an investigational adeno-associated virus 2 (AAV2) glial cell line-derived neurotrophic factor (GDNF) gene therapy for the treatment of moderate-stage Parkinson’s disease. “By enhancing levels of a naturally occurring growth factor, glial cell line-derived neurotrophic factor (GDNF) gene therapy is intended to promote the survival and functioning of vulnerable brain cells that degenerate in Parkinson’s disease”, said Alan Whone, MD, PhD, consultant senior lecturer in Movement Disorder,…

Bio-Rad has extended its anti-biotherapeutic antibodies range to now include anti-idiotypic antibodies for the atezolizumab (Lemtrada), avelumab (Bavencio), obinutuzumab (Gazyvaro), and ocrelizumab (Ocrevus) drugs. Additionally, the life science research and clinical diagnostics product specialist has also introduced its anti-monomethyl auristatin E (MMAE) biotherapeutic antibody range which can be used in bioanalysis. The anti-biotherapeutic antibody range allows for the development of reliable and robust bioanalytical assays to be used against marketed biologic drugs. According to Bio-Rad, the new anti-idiotypic antibodies for the four drugs are ideal for pharmacokinetic (PK) and antidrug-antibody assays, allowing for therapeutic drug monitoring for either innovator or biosimilar products.…

Stability testing is a vital element of ensuring a drug product is compliant with regulatory requirements, irrespective of whether you are submitting to the Food and Drug Administration (FDA), European Medicines Agency (EMA) or elsewhere. Stability studies ensure drug products remain stable during transportation, distribution, and storage, to maintain efficacy and safety throughout the lifetime of the product. Here Paul Barr, Principal Scientist at scientific consulting and testing specialist Broughton, outlines the key elements of stability testing for drug delivery devices.   The purpose of stability studies is to provide evidence on how the quality of the drug product varies with…

Cytiva has launched its Supor Prime sterilising grade filters to filtrate high-concentration biologic drugs. The latest addition to the life sciences leader’s portfolio aims to help drug developers achieve higher yields, reduce blockages, and minimise cost losses. Ed Hoare, Vice President and General Manager, Filtration at Cytiva, commented: “Our customers have been seeking a solution that accelerates the development while reducing the risks associated with high-concentration biologics. Supor Prime addresses these challenges and helps them deliver life-changing therapeutics to the patients who need them.” The Supor Prime filters reduce the amount of: Plastic required. Stainless steel installation cleaning. …

This GLP-1R / CRE Luciferase Reporter HEK293 cell line has been engineered to monitor activation of GLP-1R in cells by measuring luciferase activity, making it useful for cell-based binding assays and screening for human GLP-1R agonists. GLP-1R is known to play a key role in controlling blood sugar levels by enhancing glucose-stimulated insulin secretion. Therefore, there is considerable interest in harnessing regulation of the GLP-1R mediated signalling pathway as a therapeutic approach to type 2 diabetes which has already resulted in the development of several GLP-1 FDA-approved agonists. In addition, GLP-1R agonists have also been shown to contribute to weight management,…

Labguru (BioData) announces an agreement with Thermo Fisher Scientific to enable the distribution of its Labguru Electronic Lab Notebook (ELN) module alongside Thermo Fisher’s suite of Laboratory Information Management System (LIMS) and lab operations software solutions. With these complementary products, Thermo Fisher customers will address research management needs through enhanced digital lab connectivity, improving cross-functional collaboration and benefiting from a digitally enabled pathway to research-based innovation. Thermo Fisher opted to provide the Labguru ELN module to customers after utilising the powerful solution in its own internal labs. Thermo Fisher provides an extensive array of capabilities, including laboratory instruments, reagents and consumables offered through a scaled…

Thermo Fisher Scientific has introduced the Thermo Scientific KingFisher PlasmidPro Maxi Processor (PlasmidPro), the ‘only’ fully automated maxi-scale plasmid DNA (pDNA) purification system. PlasmidPro enables innovation at scale, providing complete automation across mini and maxi scale purification and delivering high-purity plasmid without manual column preparation and intervention. This is the latest addition to the Thermo Scientific KingFisher instrument portfolio which offers a range of plasmid DNA extraction products to help drive efficiency and consistency. Globally, there are approximately 1,700 clinical trials for cell and gene therapies. In recent years, plasmids have been instrumental in the development of cell and gene therapies, monoclonal antibody therapies and…

Aurorium, a specialty ingredients manufacturer and materials innovation partner, has announced the launch of Haelium Pharmaceutical Solutions.  “The launch of the Haelium brand will more clearly represent our position in the pharmaceutical space – a global leader dedicated to enhancing drug efficacy through high-purity solutions and drug delivery products,” said Jenny Titova, strategic marketing manager – pharmaceuticals. The Haelium brand family encompasses solutions such as high-purity buffers, reagents, solvents, extended-release coatings, and immunostimulants for therapeutic areas including peptide and oligonucleotide production, large molecule biologics, vaccines, and oral solid dosage form. Haelium’s footprint is built on four Current Good Manufacturing Practice (cGMP)…

TurboFil Packaging Machines, an equipment specialist dedicated solely to the design and development of liquid filling and assembly machines, is collaborating with Bridgewater, NJ-based Amneal Pharmaceuticals to develop an advanced automated assembly and vial filling machine for unidose liquid nasal devices. TurboFil’s system will be utilised by Amneal to produce naloxone doses, the drug used to counteract opioid overdoses.   Earlier this year, the US Food and Drug Administration (FDA) approved the over-the-counter sale of naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan and is used in the treatment of a known or suspected opioid overdose emergency.   TurboFil’s system…

Bora Pharmaceuticals has announced that it has successfully entered into an agreement for Emergent BioSolutions’ sterile manufacturing facility in Baltimore-Camden, Maryland as part of a major commercial expansion for the Company. Bora has an established footprint in the US following its acquisition of Upsher-Smith Laboratories, a generics manufacturer based in Minnesota, earlier this year. This second acquisition is the next milestone in the Company’s growth strategy, as it continues its plans to expand into sterile drug product manufacturing and grow its footprint in North America.  The newly acquired 87,000-sq. ft. facility provides drug product manufacturing services for sterile injectables and offers clinical…

In this episode of The MedTalk Podcast, Olivia Friett the editor of Medical Plastics News, is joined by Adrian Jennings, chief product officer at Cognosos, to discuss how tracking equipment can save hospitals millions. × The MedTalk Podcast · Tracking hospital equipment with AI technology

Allecra Therapeutics (also known as Allecra) and Acino have signed an exclusive licensing agreement which allows Acino to commercialise the antibiotic drug EXBLIFEP in the Republic of South Africa and members of the GCC alliance. The latter includes states like Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. The agreement came into effect on the 12th June 2024. Andreas Kranzusch, Chief Financial Officer and Managing Director at Allecra Therapeutics said: “Acino has established itself as a leader in South Africa and the GCC region. They are an ideal partner to support us as we build towards the commercialisation of EXBLIFEP…

Discovery Park has opened the doors to CoLab, a new shared lab facility. In partnership with Canterbury Christ Church University, CoLab has been specially designed for early-stage life science businesses, providing flexible bench space in a collaborative coworking environment. Dr Cornelia Wilson, senior lecturer and academic laboratory director at Canterbury Christ Church University, said: “Finding lab space is too often a blocker for promising life science spin outs and start-ups, and CoLab exists to solve this. This specialist lab offers flexible and cost-effective space in a collaborative environment, with a dedicated lab technician onsite to provide expert advice and remove the stress…

Benchling, the R&D Cloud powering the biotech industry, have announced that global pharmaceutical company Sanofi is using Benchling across more than 1,500 scientists from 30 teams.  Benchling is working with Sanofi to transition from legacy R&D systems to a digital platform through Benchling R&D Cloud; this is an integral process to enable Sanofi’s AI-powered R&D ambition. As a result of Sanofi’s digital and AI leadership, R&D teams are able to scale and accelerate groundbreaking research processes in just hours instead of weeks.    “Sanofi is paving the way for a new era of biotechnology, where every stage of R&D is faster, smarter, and more…

Regarding the integration of Telstar into Syntegon after an acquisition agreement closed between Azbil Corporation and the German company which has been announced by both firms, Telstar expresses that the company takes a very positive view about the incorporation into a business leader whose strategy is fully aligned with Telstar’s development plan. For Telstar, it represents an opportunity to maintain and grow the business, which entirely fits to the Syntegon’s core business. In this new stage, Telstar will share their talent and knowledge in the field of development of new innovative high-value solutions for aseptic production to reinforce synergies operating…

ACG has announced a strategic partnership with EY-Parthenon aiming to enhance ACG’s sustainability initiatives through a comprehensive Net Zero strategy and implementation roadmap aligned with the Science Based Targets initiative (SBTi). Combining ACG’s industry expertise with EY-Parthenon’s sustainability consultancy, the partnership seeks to significantly reduce carbon emissions and promote sustainable practices across ACG’s operations has already initiated its journey by conducting a comprehensive greenhouse gas emissions (GHG) emissions inventory and carbon footprint assessment for their most prominent products. This assessment has provided critical insights into ACG’s emissions profile, identifying priority areas for targeted sustainability efforts.  ACG, in collaboration with EY-Parthenon, is…

Asahi Kasei has announced that in April 2024 it began selling a membrane system to produce WFI (water for injection), a type of sterile water that is used for the preparation of injections. The membrane system was developed as an alternative to the conventional distillation processes for the production of WFI by leveraging system design and development capabilities of MicrozaTM hollow-fiber membrane for water treatment and filtration of liquid products. By reducing the need to generate steam, this system enables lower CO2 emissions and lower costs in the production of WFI. With its Microza hollow-fiber membrane, Asahi Kasei has provided membrane…

Lyphe Clinic has announced a partnership with Gro-Vida, a licensed medical cannabis cultivar. This collaboration marks a significant step forward in advancing patient care and access to high-quality medical cannabis products within the UK. By forming a strategic partnership with Gro-Vida, Lyphe Clinic aims to further enhance its commitment to providing superior care and uninterrupted access to medical cannabis treatments for its patients. Sophie Gamwell, Managing Director at Lyphe Clinic, expressed her enthusiasm about the partnership, stating: “We are delighted to join hands with Gro-Vida to ensure seamless access to medical cannabis for our patients. Guaranteeing a continuous and reliable supply of…

Haier Biomedical has launched the wide neck CryoBio series, a new generation of liquid nitrogen containers offering convenient access to stored samples. This latest addition to the CryoBio range also features an enhanced, intelligent monitoring system that ensures precious biological samples are kept safe and secure. Haier Biomedical’s new wide neck CryoBio series is designed for the cryogenic storage of plasma, cell tissue and other biological samples in hospitals, laboratories, scientific research institutes, disease control centres, biobanks and other facilities. The wide neck design allows users to access all racking stacks to remove samples more easily. Samples are protected with double lock and dual…