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July 19, 2019

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Use of Accelerated Conditions in Extractables and/or Leachable Studies

The purpose of this paper is to consider the scientific basis for accelerated contact conditions (via the proper combination of contact temperature and duration) for studies which involve the migration of substances (either extractables or leachables) from plastics and into contact solution (such as extraction solvent or drug products).

	Industry News

CTI BioPharma to Move to Phase 3 Study of Pacritinib for Myelofibrosis
CTI BioPharma announced the outcome of a Type B, End-of-Phase-2a meeting with the FDA for the ... read more »

Bayer, Bristol-Myers Squibb, Ono Pharmaceutical to Investigate Stivarga, Opdivo Combo Therapy
Bayer, Bristol-Myers Squibb, and Ono entered into a clinical collaboration agreement to evaluate the... read more »

Pear Therapeutics Announces FDA Submission for Somryst
Pear Therapeutics announced a submission to the FDA seeking marketing authorization for Somryst™, a ... read more »

Emmaus Life Sciences Completes Merger
Emmaus Life Sciences and MYnd Analytics announced they have completed the previously announced ... read more »

FDA Approves Treatment for Complicated Urinary Tract, Complicated Intra-Abdominal Infections
The FDA has approved Recarbrio, an antibacterial drug product to treat adults with complicated ... read more »

Mallinckrodt, Silence Therapeutics Announce Collaboration
Mallinckrodt and Silence Therapeutics announced a collaboration to develop and commercialize RNAi ... read more »

	Featured Articles

Aggregates Quantification of Biopharmaceuticals in a Wide Range of Sizes Using Orthogonal Methods While the relation of protein aggregates in biopharmaceutical products to the immunogenicity after ... read more »

Challenges in the Downstream Process of Gene Therapy Products Over the last few years, gene therapy (GT) has emerged as a promising medical tool to treat diseases... read more »

	Featured Video

Watch Video: The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products
Learn about the tools, techniques, services and best practices being used to manufacture high quality products while minimizing contamination and ... read more »

Watch Video: SKAN INTERPHEX Overview 2019
SKAN INTERPHEX Overview 2019 read more »

	Featured Products

APW Active Ingredient Processing Workstation
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TPW Tablet Processing Workstation
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	Featured Whitepaper

The NEXT GENERATION in Protein Characterization
The ability to measure and characterize changes in the secondary structure of proteins is critical to many research applications, especially the formulation and development of biotherapeutics. read more »

Single-Use Process Platforms Help Biomanufacturers Reduce Costs
There are many new challenges facing those involved in the manufacture of biopharmaceuticals. read more »

	Events

BioProcess International
Boston, MA – 09/09/2019
BPI is the largest bioprocessing event bringing you the science, technologies and partners needed to accelerate promising biologics towards commercial... event details »

Stability Testing Summit
Boston, MA – 09/23/2019
Come to the Stability Testing Summit on September 23-24, at the Hyatt Regency Boston Harbor in Boston, Massachusetts. The time has never been more ... event details »

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