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Top Stories
Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).
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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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Industry News
The UCL-Pall Biotech Centre of Excellence will address industry challenges and provide workforce training.
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A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.
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Biopharma News
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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Roche has acquired Tusk Therapeutics in a deal worth up to EUR 659 million (US$762 million).
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Supplier News
The new facility will include comprehensive mammalian process development and manufacturing capabilities.
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The company says the new equipment will reduce sample turnaround times and increase variant detection quality and accuracy.
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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.
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Regulatory News
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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Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.
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FEATURE TOPICS |
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DOWNSTREAM PROCESSING
The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).
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OUTSOURCING
Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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MANUFACTURING
Testing demonstrates an automated semi-continuous process strategy for viral inactivation with steps that mimic batch processing.
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QUALITY BY DESIGN
As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.
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AAPS PharmSci 360 Preview
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Be supported at every step in your drug discovery with the NGC Chromatography Platform from Bio-Rad Laboratories.
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Eurofins Lancaster Laboratories provides testing services for all stages of the drug development process and supports all functional areas of bio/pharmaceutical manufacturing.
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UPCOMING WEBCASTS
Timely, Accurate Analytical Purity Data Helps to Avoid Late Surprises When Scaling Up.
Automated TEM Analysis Data of Gene Therapy Vectors and VLPs
Thursday, November 1, 2018 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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Using High-Throughput Automation to Accelerate Biologic Drug Formulation
Thursday October 25, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Rapid Automated Peptide Mapping
Wednesday, October 24, 2018 at 11am EDT | 8am PDT |4pm BST | 5pm CEST
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Protein A Chromatography: Important Features in Purification to Reduce mAb Aggregation and Increase Recovery
Tuesday, October 23, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Bispecific Single-Domain Antibody Fused to Monoclonal Antibody (SMAB): The Natural Form
Wednesday, October 17th, 2018, at 11am EDT|8am PDT|4pm GMT|5pm CEST
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Events
October 14–17, 2018
November 1–2, 2018
November 4–7, 2018
more events
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eBook
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A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs.
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