Pharmaceutical Technology ePT Weekly
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PharmTech
February 21, 2019
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In this issue:

EMA Releases Report on Big Data

Effective Root Cause Determination

Fundamentals of GMP Warehouse Design


Top Stories

FDA Big Winner in Final Congressional Budget Agreement

FDA came away with the largest boost in its annual budget in a decade as part of the final spending package approved by Congress.
/ read more /


Charles River to Acquire Citoxlab in $510-Million Deal

The acquisition would strengthen Charles River's contract research capabilities.
/ read more /

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Industry News

EMA Releases Report on Big Data

A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.
/ read more /


Amyris, IDRI to Engineer Molecules for Vaccine Adjuvant Applications

The companies will use a $4.4-million grant from the National Institute of Allergy and Infectious Diseases to discover sustainable alternatives to shark squalene to use as vaccine adjuvants.
/ read more /


More Industry News
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Supplier News

Lonza, AllCells Partner on Hematopoietic Primary Cells

The partnership will expand Lonza's offering of hematopoietic cell lines.
/ read more /


Sharp Invests in Interactive Response Technology Solution

Sharp has invested $650,000 into enhancing its Interactive Response Technology (IRT) solution.
/ read more /


More Supplier News

Bio/Pharma News

Sanofi Gets FDA Approval for Nanobody-Based Therapeutic

The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.
/ read more /


FDA Approves Novartis Drug for Tropical Disease

The approval expands use of Egaten (triclabendazole), which has been recommended by the WHO since 2005 for treating liver fluke infestation.
/ read more /


More Bio/Pharma News

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Exclusive Interview from AAPS
Developing New Technologies in Controlled Release
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Exclusive Interview from AAPS 2018
Cutting Edge Formulations in Topic Drug Development
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Regulatory News

FDA Publishes Competitive Generic Therapy Guidance

The guidance explains the process of applying for competitive generic therapy designation.
/ read more /


 

Poland and Slovenia Added to EU–US Mutual Recognition Agreement

The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.
/ read more /


More Regulatory News

FEATURED TOPICS

MANUFACTURING

Fundamentals of GMP Warehouse Design

Storage and retrieval methods and the unique requirements found in building codes are crucial considerations.
/ read more /

ASEPTIC/STERILE PROCESSING

As Technology Advances, Annex 1 Falls Short

Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.
/ read more /


OUTSOURCING

Mind the Gap: Tech Transfer from Early Stage Cell Culture to Phase I Clinical Manufacture

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.
/ read more /

QUALITY

Effective Root Cause Determination

Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
/ read more /


UPCOMING WEBCAST

Benefits of Using High-Functionality Excipients in a Continuous Process
Wednesday, March 13, 2019 at 10am EDT | 2pm GMT | 3pm CET
Register now


Top 4 Quality Trends for 2019
Pharma Quality Outlook Survey

Wednesday, March 6, 2019 at 11am EST | 8am PST | 4pm GMT | 5pm CET
Register now


Events

IFPAC Annual Meeting

March 3–6, 2019

2019 PDA Annual Meeting

March 11–13, 2019

Pittcon 2019

March 17–21, 2019

more events

2019 PDA ANNUAL MEETING PREVIEW

Chemic Laboratories, Inc

Chemic Laboratories is a full-service cGMP/GLP contract analytical chemistry laboratory that provides an array of R&D and cGMP testing services.
/ read more /

Connecting People, Science, and Regulation®

The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community.
/ read more /

Veltek Associates, Inc.

With over 35 years of contamination control experience, VAI's products and services include a comprehensive line of disinfectants, sporicides, residue removers, and more.
/ read more /


New Products and Services

Catalent Pharma Solutions

Catalent Pharma Solutions offers its partners end-to-end solutions, from drug formulation and drug delivery technologies, to manufacturing and clinical supply services.
/ read more /

Emergent Biosolutions

Emergent provides contract manufacturing services for the aseptic fill/finish of vials and syringes: liquid and lyophilized products.
/ read more /

Dispersers

Ross Bow Tie Dispersers, or High Viscosity Dispersers, are heavy-duty mixers designed for heavy pastes and viscous liquids up to several hundred thousand centipoise.
/ read more /


eBOOKS

Laboratory Best Practices 2018 eBook

The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing.


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