Electronic production records give you a holistic view of your manufacturing operations, which is essential to achieving your key performance indicators (KPIs), such as zero defects in manufacturing, faster time to market, high customer satisfaction, a competitive advantage, etc. Read this industry brief and you will learn:  That paperless manufacturing supports long-term growth by reducing overall operating costs.  How electronic production records integrate with your other enterprise management systems.  Why paperless manufacturing is essential to overseeing production (i.e., materials management, equipment, document reviews, employee training, etc.).  How digital maturity in manufacturing reduces waste, scrap, and duplicated efforts.  By completing the form below, and pressing submit…

The advance of the sublimation front during primary drying in a freeze-drying process is one of the most critical parameters whose control is key to understand the drying kinetics for cycle development and validation as well as to ensure process robustness and repeatability during production cycles. In addition, new GMP conditions updated in Annex 1, makes the lyophilization process more challenging. The following article presents a new solution to overcome the current market needs with a new PAT tool capable to monitor the advance of the sublimation front temperature interface using single use wireless probes displaying process product temperature data…

Freudenberg Medical is to establish a second manufacturing site in Costa Rica. With this $25 million investment the company is expanding its technologies to deliver increasingly complex products to its global customer base. “We are proud to be one of the first global CDMO partners in Costa Rica, having established our first production facility here more than 12 years ago,” said Dr. Mark Ostwald, CEO of Freudenberg Medical. “This expansion strengthens our strategy of being close to our customers and offering them efficient solutions along the entire device lifecycle – including cost-effective manufacturing capabilities on a large scale.” Freudenberg Medical’s new facility…

The biopharmaceutical industry is undergoing a shift propelled by intricate biologics and their impact on global healthcare. With advancements in technology and subsequent therapies, particularly in antibody-based therapeutics, the industry’s landscape is witnessing a surge in innovative modalities, such as bispecific antibodies (BsAbs), reshaping treatment methodologies and market trajectories.  The rise of complex biologics has not only revolutionised therapeutic approaches but also triggered a significant economic surge. The global antibody-based therapy market, estimated at $186 billion in 2021, foreshadows an upward trajectory, projected to grow at a compound annual growth rate of 13.2% from 2022 to 2028. The projected growth…

Osivax have announced that the first participant has been vaccinated in its new Phase 1 trial (NCT06128382) evaluating OVX033, a broad-spectrum sarbecovirus vaccine candidate.  Recently, preclinical data published in Frontiers in Immunology demonstrated OVX033’s proof of cross-protection against three SARS-CoV-2 variants of concern. In a rabbit toxicology study, the vaccine candidate also showed an strong safety and tolerance profile after intramuscular administration. The first-in-human study will be conducted at the Clinical Investigation Center in Vaccinology Cochin Pasteur (CIC) in Cochin Hospital in Paris (AP-HP, Inserm) under the supervision of Odile Launay, MD, PhD, Professor at Paris Cité University. “OVX033 has been shown in preclinical…

FUJIFILM Healthcare Europe has unveiled the ECHELON Synergy, a revolutionary MRI scanner for efficient, high performance imaging with optimal patient comfort. The 1.5 Tesla superconductive system employs AI-powered Synergy deep learning reconstruction (DLR) to enhance the sharpness of images and the speed of scanning for maximum efficiency. The 70 cm wide bore ECHELON Synergy MRI scanner has been meticulously designed to empower radiographers to deliver comfort-focused care for a remarkable patient experience. The imaging system accommodates a 62 cm wide, height adjustable table with a 250 kg capacity, and features a FlexFit radiofrequency (RF) coil system for total control over individual or multiple…

The drug delivery and packaging industry is poised for a promising 2024 following Pharmapack Europe held January 24th and 25th. Pharmapack recorded a joint record attendance of 5,500 and saw a strong resurgence in industry confidence in the Pharmapack Index; many new innovations in the largest ever Pharmapack Awards and Start up Hub; and a proliferation in industry dealmaking and partnering. In total there were 370+ exhibitors from more than 80 countries. This year’s Pharmapack Europe witnessed a 13% rise in attendance and a high turnout is seen as a strong positive signal for the drug delivery and packaging prospects. Exhibitors from…

Written by: Bryan Hill (Global / Americas), Gaga Syal (GGM) & Rohit Alimchandani (UK) – Cognizant. For life sciences organisations, the pressure to speed up the time to market of new drugs and therapies continues at pace, alongside the need to reduce the cost of doing so. What is needed is a new technology paradigm that will reinvent the life sciences business model by connecting data, knowledge, people, and insights. Enter Quantum Computing Pharmaceutical Research and Development is now replete with fields of research that offer potential use cases for quantum computing. These include quantum simulations for molecular design, molecular similarity, protein folding and…

Written by: Andy Clarke, Country Manager (UK), YSDS. Low Volume, High Value The low volume life science market has significant complexities – an educated understanding of Good Distribution Practice (GDP) methods and processes is required before any shipments can commence, whilst the items can range from novel prototypes, up to final stage development pre-trial products, and can also include component ingredients and failed items being returned for analysis. Consequently, the need for add-on features such as unique packaging, individual insurance, and special requests in transit is comparatively high on a “per shipment” basis. Additionally, customs teams in each country are…

Artificial intelligence (AI) has the potential to radically alter the field of healthcare, and it’s already enhancing medical imaging. Penny Pinnock, Siemens Financial Services (SFS), explores how more efficient and accurate technology is contributing to improved healthcare outcomes and helping private hospital groups cope with supporting NHS backlog. Thanks to AI, diagnostic imaging is among the most rapidly advancing areas of healthcare equipment. New applications and models are emerging regularly to improve diagnoses. Preliminary results from a major trial in Sweden showed the technology could almost halve the human workload in breast cancer screenings. Research from Seoul National University suggested AI…

GSK have announced that it has completed the acquisition of Aiolos Bio, a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with respiratory and inflammatory conditions. As previously announced, the acquisition of Aiolos includes AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma. AIO-001 could expand GSK’s respiratory biologics portfolio to potentially reach the 40% of severe asthma patients with low T2 inflammation (a type of overactive immune response associated with asthma). AIO-001 has the potential to be administered every six…

Chiesi Ltd, a Manchester-based biopharmaceutical company, has today announced a carbon neutral respiratory portfolio. Chiesi has already committed to a series of projects that will lead to a reduction of 90% direct greenhouse gas emissions generated, as well as emissions associated with the purchase of electricity and heat by 2030, compared to 2019. These include initiatives such as: A transition to 100% renewable electricity at all Chiesi Group sites. Progression of the electrification of its car fleet. installing technology at manufacturing sites that aims to capture propellant emissions. Energy efficiency measures. Another key element of Chiesi’s carbon reduction…

Ipsen have announced that the U.S. FDA has approved the supplemental new drug application for Onivyde (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy. “The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen,” said Christelle Huguet, EVP and Head…

AbbVie has completed its acquisition of ImmunoGen. “Together with ImmunoGen, we have the potential to continue redefining the standard of care for those living with cancer,” said Robert A. Michael, president and chief operating officer, AbbVie. “The addition of ImmunoGen’s treatment for ovarian cancer will accelerate our ability to help patients today, expand our oncology pipeline and drive long-term revenue growth well into the next decade. I want to thank ImmunoGen for their efforts to advance science for patients and we look forward to welcoming our new colleagues to AbbVie.” ELAHERE (mirvetuximab soravtansine-gynx) is the first and only antibody-drug conjugate (ADC) approved by…

Biogen Inc. have announced the European Commission (EC) has authorised SKYCLARYS (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. SKYCLARYS is the first treatment approved within the European Union for this rare, genetic, progressive neurodegenerative disease. “In my clinical practice, I have seen the devastating impact that Friedreich’s ataxia has on patients and their families,” said Sylvia Boesch, M.D., MSc, Principal Investigator of the MOXIe study and Head of the Centre for Rare Movement Disorders Innsbruck, Department of Neurology, Medical University Innsbruck, Austria. “Friedreich’s ataxia patients treated with SKYCLARYS in the clinical trial…

PanTera, the Belgian joint venture created by IBA and SCK CEN to secure large-scale production of alpha-emitting radioisotopes, have announced the signing of a capacity reservation agreement with Bayer for the supply of actinium-225 (225Ac) starting in the second half of 2024. Sven Van den Berghe, CEO of PanTera, commented, “PanTera’s emerging ability to start supplying 225Ac this year will allow research and clinical trials in this domain to advance. The combined expertise and technology from SCK CEN and IBA places PanTera in a unique position to become the go-to global supplier of 225Ac for clinical trials and commercial use. PanTera…

Chanelle Pharma has been sold by its founder Michael H Burke to Exponent, a leading private equity firm. Headquartered in Loughrea, Co. Galway, Chanelle Pharma is Ireland’s largest indigenous manufacturer of generic pharmaceuticals for animal and human health.  The terms of the sale have not been disclosed. Chanelle Pharma provides a spectrum of services to its customers including research and product development, registration and production of generic pharmaceuticals for both Human and Veterinary Pharmaceuticals.  As a leading European private equity firm, Exponent has a strong track record of successfully transforming and growing the companies they invest in. The firm recently opened…