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Top Stories
The companies will develop treatments for a range of neurological and inflammatory diseases.
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Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.
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Industry News
Formulation issues cause significant drug project delays and project failures, according to a 2018 survey conducted by Informa Pharma Intelligence, Rentschler Biopharma, and LEUKOCARE.
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The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.
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Supplier News
The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.
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GE Healthcare will collaborate with Wego Pharmaceutical in China for local production and supply of GE Healthcare's Fortem single-use consumables.
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The future of pharmaceutical chemical imaging
Renishaw's RA802 Pharmaceutical Analyser offers scientists a step change in vibrational spectroscopy-based imaging techniques. Three of the most common complaints about conventional Raman microscopy and infrared microscopy (IR microscopy) systems are sample focus, speed of analysis and ease-of-use. The RA802 Pharmaceutical Analyser combines Renishaw's proprietary LiveTrack™ and StreamLine™ technologies to generate chemical images up to 150 times faster than conventional methods.
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Bio/Pharma News
The International Society for Pharmaceutical Engineering (ISPE) named Shire as the ISPE 2018 Facility of the Year Awards Overall Winner for a facility integration project in Los Angeles, CA.
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AbbVie will grant Momenta license to launch a biosimilar to AbbVie's Humira.
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Regulatory News
Leaders of the two parties are open to challenging the status quo on drug costs and spending.
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The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
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FACILITIES
Barrier materials, scavengers, and good seal integrity maximize shelf life of oral solid-dosage drug packaging.
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MANUFACTURING
Mechanistic process and product modeling turns data into knowledge that can be extrapolated with known confidence for design space characterization and risk assessment.
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FORMULATION
As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.
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November 28–29, 2018
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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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