| August 2015, Volume 11 Issue 8
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API Synthesis & Manufacturing
Early adopters look to speed up the use of continuous API manufacturing, but lack of expertise hinders adoption.
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Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications and the industry has only scratched the surface of what might be possible.
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“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.
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The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
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API Supplier News
SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.
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Investment group Ardian will acquire the fine chemicals business activities of DPx Holdings B.V.
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Outsourcing Update
Memories of hard economic times may discourage CDMOs from expanding capacity.
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Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins
On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
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Contract Services Update
AMRI expands its API portfolio and European presence through acquisition of Gadea's Crystal Pharma Group.
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Investment at Capsugel's Edinburgh, Scotland facility will expand the company's liquid- and semi-solid-fill capsule manufacturing capacity.
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Evans Analytical Group expands into the pharmaceutical/biopharmaceutical industry with acquisition of ABC Laboratories.
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Consisting of a needle hub and a needle shield, the new syringe closure system is partly produced by means of a two-component injection molding process.
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CDMO for semi-solid and liquid manufacturing realigns operations at Texas facility.
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Charles River strengthens its endotoxin testing and bacterial identification detection capabilities with the addition of Celsis' products.
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Investment in Powdersize adds particle-size control solutions to Xcelience's capabilities.
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The investment doubles the company's capacity to meet increasing demand for its biologics contract testing and biosimilar characterization services.
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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling
On Demand
Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
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Supply Chain
World Courier receives pharmaceutical storage and transportation accreditation in the United Kingdom.
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CSafe and AES will support controlled-temperature shipping through the Basel, Switzerland airport from a new service center.
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Stability Assessment for Shipment of API and Drug Products
On Demand
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
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Regulation and Compliance
FDA's quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.
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EMA's revised guideline on the implementation of accelerated assessment is open for public consultation.
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Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.
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Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.
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Practical Guidance for Successful Mammalian Cell Banking and Cell Line Characterization
On Demand
Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to
learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
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