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June 20, 2019
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   Integrated Outsourcing from RSMs to APIs

As active pharmaceutical ingredient (API) complexity has increased, so too has the raw material supply chain. Drug manufacturers must ensure that these materials meet strict regulatory guidelines regarding impurity levels, that their quality is well documented to mitigate risk and that they can be traced throughout the supply chain. An integrated supply chain with transparency among sponsors and suppliers ensures that regulatory starting materials (RSMs) are well characterized and free of impurities that can impact the final drug product.

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» Industry News
 
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» Featured Articles
The Evolving Shape of the ADC Market
The scale of patient demand has fuelled an overarching healthcare market need to expand the drug development pipeline to generate more biologics to treat multiple diseases and innovative new ... read more »
Pharmacokinetic and Statistical Considerations in First-in-Human Clinical Trials
One of the major challenges when undertaking a first-in-human (FIH) clinical trial is how to appropriately plan and analyze the pharmacokinetics (PK) of a new drug. Although PK assessment in the ... read more »
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» Featured Partners
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  [Webinar] Pharmaceutical Development of Oligonucleotides

Oligonucleotides are an emerging class of DNA and RNA therapeutics that address a number of unmet medical needs. As with many biopharmaceuticals, the complex structure of oligonucleotides makes their large-scale synthesis both challenging and imperfect. A number of impurities are generated during manufacturing, many of which are hard to identify using available analytical methods. Furthermore, the... read more »
» Featured Video
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  Watch Video: Halo Pharma's Full-Range Facility in Montreal, Canada
Vice President and General Manager Maryse Laliberte of Halo Pharma talks about their facility and its full range capability including process optimization, validation and a dedicated team to supprt ... read more »
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  Watch Video: Interview with Michele Luche from AMRI at AAPS 2016
AMRI is a trusted partner for global contract research, testing and manufacturing services for the biopharmaceutical industry. Our specialized solutions include Drug Discovery, such as medicinal ... read more »

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» Featured Whitepaper
Host Cell Protein Analysis in Biologic Drug Development
This whitepaper reviews fundamental aspects of HCPs that pertain to biologic drug development and presents current and emerging approaches to HCP ... read more »
Process Development for Lyophilized Products
Identifying the failure points for a product is a necessary part of product development, and enables the development scientist to design a ... read more »
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| Events
EVENT
  Clinical Operations in Oncology Trials East Coast 2019
Cambridge, MA –  07/10/2019
The Clinical Operations in Oncology Trials (CTO) meeting returned to Boston for its 6th year with over 150 attendees from biopharmaceutical, medical ... event details »
EVENT
  8th Clinical Trials Inspection Readiness Summit
Philadelphia, PA –  08/14/2019
The 8th Clinical Trials Inspection Readiness Summit is intended to arm attendees with strategies when designing and implementing a culture of ... event details »
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