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Top Stories
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
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FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.
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Industry News
Researchers at Vanderbilt University Medical Center have isolated the first human monoclonal antibodies (mAbs) that can neutralize norovirus, a virus that causes acute gastrointestinal (GI) illness.
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Researchers from Ruhr-Universität Bochum in Germany and the National Institutes of Health modified the protein Nurr1 to enter cells from the outside, possibly enabling the protein to become a drug development candidate for illnesses such as Parkinson’s disease.
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Biopharma News
The companies will develop therapies targeting the in-vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform.
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Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.
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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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Supplier News
The collaboration will focus on developing manufacturing solutions for biosimilars.
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Becton Dickinson’s (BD) Advanced Bioprocessing business will be integrated into Thermo Fisher's Life Sciences Solutions segment.
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Regulatory News
The agency approved AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia.
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FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company's lack of procedures to prevent microbiological contamination.
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FEATURE TOPICS |
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DOWNSTREAM
Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.
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QUALITY SYSTEMS
Trace elements in raw materials may impact the quality and safety of the finished biologic product, according to industry experts.
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FORMULATION
The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.
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UPCOMING WEBCASTS
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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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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Screen Hundreds of N-Glycans per Day: More Samples – Better Decisions – Faster
Europe Broadcast: Thursday, October 4, 2018 at 2pm BST | 3pm CEST
US Broadcast: Thursday, October 4, 2018 at 11am EDT | 10am CDT | 8am PDT
Asia Pacific Broadcast: Friday, October 5, 2018 at 11am CST | 12pm JST | 1pm AEST
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The Multi-Attribute Method (MAM): Advancing Biopharmaceutical Discovery, Development, and Manufacturing
Wednesday, October 3, 2018 at 11am | 8am PDT | 4pm BST | 5pm CEST
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Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Aggregates
Wednesday, September 19, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Events
September 26–27, 2018
October 9–11, 2018
October 9–11, 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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