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Top Stories
The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.
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Biotechnology developers should be aware of subtle differences between the way that European and US patent authorities approach monoclonal antibodies.
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Industry News
The UCL-Pall Biotech Centre of Excellence will address industry challenges and provide workforce training.
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This year's awards attracted more than 250 entries, which included innovations in products and service offerings from across the bio/pharmaceutical supply chain and honored companies and individuals driving the industry forward.
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Supplier News
Funding from Innovate UK will be used by Medherant to support manufacture of transdermal patches for clinical trials.
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The investment includes an upgrade and expansion of the company's packaging and softgel encapsulation capabilities at its facility in Aprilia, Italy.
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Bio/Pharma News
The companies will work together to discover, develop, and commercialize immunotherapies for patients with solid-tumor cancers in a collaboration worth $695 million per program.
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The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline's specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.
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Ensure you are up to date on the latest regulations and have the tools to navigate market approvals in the field of advanced therapy by attending the 2018 PDA Cell and Gene Therapy Conference, Oct. 23-24. In less than two weeks, industry and regulatory experts will share insight on topics, including the progress of gene editing, regulatory considerations for development and commercialization, and lifecycle management.
Register now! |
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Regulatory News
Insmed's Arikayce (amikacin liposome inhalation suspension) is the first drug approved under the agency's Limited Population Pathway for Antibacterial and Antifungal Drugs, established to support development of antibiotics for unmet medical needs.
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The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a 'no-deal' Brexit scenario.
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Attend our upcoming webinar on Tuesday, October 23, 2018 at 11 am EDT on Sterility Testing: Best Practices and Use of Isolator Technology. Learn strategies and best practices for maximizing the conditions of a sterility test environment, as well as reducing the risk of inaccurate results for sterility testing through the use of isolators and vaporized hydrogen peroxide (VHP).
Register now to save your seat. |
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VACCINES
Accelerated development of new preventives raises challenges for CMC evaluation and production.
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FACILITIES
Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.
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When it comes to patient safety, is close enough ever good enough?
For critical assays like final product sterility, confidently finding nothing ultimately means everything. Celsis® rapid microbial detection determines your product's safety by providing a definitive yes or no answer to the most critical of decisions, delivering results a week faster than traditional methods.
Unlock new levels of confidence in your product at criver.com/celsis |
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MANUFACTURING
Preventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.
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FINISHED PRODUCT ANALYSIS
In this three-part podcast series, Rob Thomas, principal consultant at Scientific Solutions, discusses the impetus behind his book, Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide.
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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry. Learn More |
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UPCOMING WEBCASTS
Insoluble APIs Scaring You?
Don't be Afraid of Nanoparticles!
Wednesday, October 31, 2018 at 11am EDT|8am PDT|3pm GMT|4pm CET
Register now
Planning Successful Launches of Complex Drug Products
Tuesday, October 30, 2018 at 11am EDT|8am PDT|3pm GMT|4pm CET
Register now
Sterility Testing: Best Practices and Use of Isolator Technology
Tuesday, October 23, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now
Successfully Navigating the Analytical Environment of Complex Generic APIs
Tuesday, October 16, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now
Implementing Transmission Raman for Fast Content Uniformity Testing – from Feasibility Evaluation to a Validated Release Method
Europe: Thursday, October 11, 2018 at 2pm BST/ 3pm CEST
North America: Thursday, October 11, 2018 at 11am EDT/ 8am PDT/ 10am CDT
Register now
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Events
October 14–17, 2018
November 1–2, 2018
November 4–7, 2018
more events |
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eBOOKS
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This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics. |
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