April 2016
Volume 12 Issue 4
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API Synthesis and Manufacturing
Manufacturers and contract development and manufacturing organizations are developing processes and facilities to meet growing specialty API demand.
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Determining the appropriate amount and type of screening challenges drug developers when identifying relevant crystalline forms.
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Pharma companies must weigh cost efficiencies of global API sourcing with increased complexities of monitoring for compliance and quality.
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INTERPHEX 2016
KEYNOTE SERIES:
CONTRACT SERVICES
MARKET 2016 UPDATE
How will consolidation in the bio/pharmaceutical and contract services market, a changing financial market, and an active political and regulatory year shape the fortunes of the contract services market? In his annual presentation, industry expert Jim Miller will offer his perspectives on the contract services landscape for the next few years.
Wednesday, April 27, 2016, 10:30 am–11:30 am
Learn more
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Proprietary content and intelligence delivered to your in-box.
In-depth analyses. Searchable online databases. Monthly and quarterly newsletters from Jim Miller and his expert staff. All focused on the bio/pharmaceutical outsourcing industry and emerging markets. We keep you informed about what is driving change and how it will impact your business.
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Unsafe material may remain in the US supply chain, according to a March 29, 2016 letter to FDA Commissioner Califf.
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Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
On Demand
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Supply Chain Update
Pharma’s traditionally conservative approach to supply-chain management may be hindering its ability to adapt to changes in demand.
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Risk management takes center stage, and new mobile apps are being developed to help assess global risks in real time.
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The service center will act as a hub for delivery, maintenance, calibration, and technical support for the company.
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In the Lab
A new 3D modeling and data-extraction technique Improves X-ray crystallography analysis of proteins.
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Outsourcing Update
Contract biopharmaceutical manufacturing has been growing steadily and is expected to reach $4.1 billion by 2019.
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Contract Services Update
With a new name formed from the legacy company names, Alcami offers development services, analytical testing, and API and finished drug development and manufacturing.
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The company broke ground on a $79 million production facility at its Ravensburg Schuetzenstrasse site.
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The module was installed in the company’s Watson laboratory information management system in Poitiers, France.
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The investment includes facility upgrades and expansion of development capabilities.
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The inspection confirmed that the facility was compliant with GMP guidelines.
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Collaboration will provide for unified development and manufacture of antibody drug conjugates.
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