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Top Stories
The European Commission (EC) has approved Novartis' chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
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Girish Malhotra argues in CPhI Annual Report that shorter approval times and financial incentives are needed to promote manufacturing improvements.
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Industry News
Preliminary survey results rank the United States, Germany, and Japan as tier-one nations for bioprocessing performance and potential.
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PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.
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Biopharma News
The European Commission (EC) approved GlaxoSmithKline's (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.
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Bristol-Myers Squibb appointed a new executive vice-president and chief commercial officer from within the company, effective immediately.
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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 company is certified as a manufacturer of pressure vessels and components for use in China.
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Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).
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Regulatory News
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.
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Dompé Farmaceutici's Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.
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FEATURE TOPICS |
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ANALYTICAL METHODS
Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.
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REGULATORY
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
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UPCOMING WEBCASTS
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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Taking Charged Variant Analysis of Therapeutic Proteins to the Next Level
Friday, September 14, 2018 at 11am EDT | 8am PDT |4pm BST | 5pm CEST
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Rapid Low-level Identification and Quantitation of Host Cell Proteins
Europe: Thursday, September 6, 2018 at 2pm BST | 3pm CEST
North America: Thursday, September 6, 2018 2pm EDT | 1pm CDT | 11am PDT
Asia Pacific: Friday, September 7, 2018 at 11am CST | 12pm JST | 1pm AEST
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Events
September 26–27, 2018
October 9–11, 2018
October 9–11, 2018
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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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