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Market Reports
How CRDMOs are shaping the next generation of antibody-drug conjugates
To explore how CRDMOs are leading innovation in ADC development, Dr Kevin Robinson spoke with Srivats Rajagopal, Senior Director, Cell and Protein Sciences, Biology Solutions at Aragen Life Sciences, about key technological advancements and evolving partnership models that are redefining what it means to outsource in this space
NICE recommends enfortumab vedotin with KEYTRUDA for adults in England/Wales with untreated metastatic urothelial cancer
The results from the Phase III study EV-302/KN-A39 showed nearly a doubling of survival rates in patients compared with those who received platinum-based chemotherapy, which is the current standard of care in the UK
Start with the end in mind: the role of materials control in early CMC strategy for cell therapies
Cell and gene therapy products are complex in their design, nature and mode of action. Because of this, the road to market can be a challenging one; littered with variables and failures, what might have been a valuable treatment often fails to reach much-in-need patients
Empowering patients with self-administration drug delivery devices
Incorporating self-administered drug-device combination products into clinical trials benefits patients and manufacturers alike, reports Bill Welch, Executive Director of Market Development at PCI Pharma Services
Excipients step into the spotlight with sustainable and nano solutions
How multifunctional and natural materials are reshaping formulation science
How onco-HPAPI manufacturing is adapting to a new era
The oncology landscape is undergoing a quiet but powerful shift. Pharmaceutical companies, once focused primarily on novel compounds, are now increasingly exploring repurposing opportunities with existing high-potency oncology APIs (onco-HPAPIs)
Outsourcing in pharma: a comprehensive guide to strategic advantages and considerations
Outsourcing in pharma drives agility, compliance, and efficiency—NSF delivers expert audits, training, remediation, and embedded support
Poolbeg granted FDA Orphan Drug Designation for POLB 001
The US FDA grants orphan status to support the development of medicines for rare disorders affecting fewer than 200,000 people in the US
From data silos to streamlined connectivity: how biopharma can prepare for ESMP
Sponsors that centralise their product information will not only help to pre-empt drug shortages but also improve their capacity for collaboration with connected systems and data
Freeze drying ADCs: points to consider for industrial applications
As antibody-drug conjugates gain momentum in the pharmaceutical industry, manufacturers are increasingly looking to implement safe and effective process trains to produce them. Lyophilisation experts at GEA Pharma & Healthcare assess some of the most critical challenges and how to overcome them
The ABCs of ADCs: manufacturing ultra-high potent active ingredients
Senior Technical Manager at Sterling Pharma Solutions, Matt Miklas, presents a pragmatic approach to the safe and cost-effective production of highly potent pharmaceutical molecules, including antibody-drug conjugate (ADC) payloads
Why potency assays are a crucial consideration for CGT manufacturers
Potency assays can enhance the efficiency of cell and gene therapy development and commercialisation, while also bringing down costs
How iPSCs can bridge the translational gap in neuroscience
Affecting more than one in three people, neurological disorders have a vast impact on global health while exacting a tremendous cost, reports Dr Max Mirza, Vice President of Neuroscience Drug Discovery at Sygnature Discovery
Clinical trials: current insights and future perspectives
To keep up with the ever-evolving landscape of clinical trials, companies must conform to regulations and consider how to make the study process patient-centric
Recombinant versus synthetic peptide synthesis: the perks and drawbacks
Since the introduction of novel peptide drugs into the market, the demand for polypeptide manufacturing has significantly increased, reports Dr Philipp Markolin
ACHEMA 2024 champions a competitive pharmaceutical industry
More than 2800 exhibitors from 56 nations — as well as 106,001 attendees from 141 countries — gathered in Frankfurt for ACHEMA 2024 to showcase the latest equipment and processes for the pharmaceutical industry
How predictive and preventive maintenance can optimise your pharmaceutical manufacturing line
With a tailored approach to maintenance, manufacturers can extend their system’s lifetime and anticipate time-consuming breakdowns before they happen
Factors driving the expansion of the multiple myeloma drug market
The multiple myeloma market has seen a range of immune-targeting therapeutics gain accelerated approval from the US FDA … and sales are predicted to skyrocket in the coming years
Biosecurity threats and business as usual
A new version of a United States congressional bill (the Biosecure Act) that restricts US companies from doing business with certain Chinese biotechnology organisations, including WuXi AppTec and WuXi Biologics, gives American companies until 2032 to terminate their associations with these firms and find new partners
Annex 1-compliant freeze drying: a technology supplier’s perspective
Jessica Wagner, Validation Engineer at GEA, tells Dr Kevin Robinson how the company has embraced the updated version of Annex 1 and implemented the new changes. Key objectives were to remain compliant and demonstrate to their customers — both current and future — how the amends would be incorporated into ongoing or upcoming projects
Optimising labelling with robotics for improved accuracy and efficiency
Robotics can significantly enhance the labelling process during pharmaceutical packaging by increasing accuracy whilst reducing costs and labour
How efficient compressed air delivery can save you money
Investing in optimal filtration systems for compressed air delivery is crucial in saving money and reducing energy usage
How to proactively address EU HTAR implementation challenges before 2025
Data landscape challenges within the European Union (EU) have historically been driven by the different laws, processes and regulatory standards of its 27 member states (MS). As a result, drug therapeutics and health technology developers have faced the challenge of duplication of assessment efforts
Adding more to the cell and gene therapy playbook
With notable advances in various forms of administration, including making the use of viral vectors safer, non-viral delivery with lipid nanoparticles and the growing application of electroporation, Dr Kevin Robinson (KSR) recently caught up with Jason Potter (JP), Director of Cell Biology R&D at Thermo Fisher Scientific, to learn more about how the company is helping the pharmaceutical industry to develop cell and gene therapies
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NICE recommends enfortumab vedotin with KEYTRUDA for adults in England/Wales with untreated metastatic urothelial cancer
The results from the Phase III study EV-302/KN-A39 showed nearly a doubling of survival rates in patients compared with those who received platinum-based chemotherapy, which is the current standard of care in the UK
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How CRDMOs are shaping the next generation of antibody-drug conjugates
To explore how CRDMOs are leading innovation in ADC development, Dr Kevin Robinson spoke with Srivats Rajagopal, Senior Director, Cell and Protein Sciences, Biology Solutions at Aragen Life Sciences, about key technological advancements and evolving partnership models that are redefining what it means to outsource in this space
A natural remedy for brain metastasis
Milk thistle extract might be a promising complementary treatment for cancer patients, reports Andrea Zangara, Scientific Marketing Manager, Euromed
Recombinant versus synthetic peptide synthesis: the perks and drawbacks
Since the introduction of novel peptide drugs into the market, the demand for polypeptide manufacturing has significantly increased, reports Dr Philipp Markolin
Continuous manufacturing: the facts and the future
Many companies talk about continuous manufacturing (CM), but few speak with the experience of actually implementing a continuous process line. Dr Kevin Robinson spoke to GEA’s Richard Steiner to find out why
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