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PharmTech Europe
20 March 2018

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Top Stories

Can Early Development Strategies Avoid Later-Stage Disasters?

Assessing potential formulation and manufacturing issues in early development phases can improve a drug’s chances for success.
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Data Integrity Educational Sessions at INTERPHEX

Experts at INTERPHEX 2018 will discuss regulatory requirements for data integrity and best practices for data integrity and process security.
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Industry News

Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate for Injection

The company is recalling Methylprednisolone Sodium Succinate for Injection, USP, 40 mg, 125 mg, and 1 g due to out-of-specification impurity results.
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FDA’s Gottlieb Hits Innovators, Insurers for Blocking Biosimilar Uptake

The FDA commissioner outlined the agency’s initiatives to reward innovation and biosimilars development.
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More Industry News

Regulatory News

EMA Advises Recall of AbbVie, Biogen MS Drug

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen’s multiple sclerosis drug Zinbryta (daclizumab beta).
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USP Cancels Revisions to Packaging Chapters

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
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More Regulatory News

Bio/Pharma News

ProBioGen and Surface Oncology Sign Second Antibody Manufacturing Program

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.
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Sanofi Acquires Biogen’s Bioverativ

The $11.6-billion acquisition strengthens Sanofi’s position in hematology and specialty medicines.
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More Bio/Pharma News

Supplier News

Pfizer CentreOne Releases First Green-Chemistry-Driven API

The new progesterone active pharmaceutical ingredient, used captively by Pfizer for the past four years, reduces carbon footprint by more than 70%.
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GRAM Adds Syringe Filling Capabilities

Grand River Aseptic Manufacturing announces first planned investment in capacity expansion.
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More Supplier News

FEATURED TOPICS

Formulation

Formulating Topical Products Containing Live Microorganisms as the Active Ingredient

Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.
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Outsourcing

Current Challenges in Bioprocesses Development

Development and adoption of new technologies create challenges that may take years to resolve.
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Standards & Regulations

FDA Heightens Drive for Transparency

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
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Analytics

Stability Testing Determines Proper Drug Storage Parameters

Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.
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Product Profiles

New i-Series Plus integrated HPLC

Significantly improved analytical productivity with automated pretreatment operations
Shimadzu’s i-Series Plus expands the product line and improves performance and user-friendliness. With i-Series Plus, pretreatment operations have been automated, such as the processes to dilute samples and add reagents.
/ Read more/

Veltek Associates, Inc.

SMA MicroParticle ICSTM
VAI is pleased to announce the addition of the SMA MicroParticle ICS line of non-viable particle counters that utilize the latest innovation in particle counting technology, to our contamination control portfolio.
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Wickham Laboratories Ltd–

Microbiology & toxicology contract testing for the pharmaceutical and medical device industries
Wickham Laboratories Ltd is a trusted name in the pharmaceutical and medical device industries with over 50 years of experience in contract testing, research and consultancy.
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Take the survey

Biopharmaceutical Manufacturing Survey

Participate in BioPlan’s 15th Annual Global Biopharmaceutical Manufacturing Study. Share your insight on current global and regional trends affecting biomanufacturing and BioPlan will donate $15 (up to $2,000) on your behalf to global health charities. Participants also receive a free aggregated summary of this year's results and an updated 15 Top Trends in Biopharmaceutical Manufacturing White Paper.

LIVE WEBCAST

Best Practices for Spray-Dried Dispersion Formulation Selection and Early Development
Live Webcast: Wednesday, March 28 at 11:00 EST
Register now


ON DEMAND WEBCASTS

Top Quality Trends for 2018: Pharma Quality Survey Report
On Demand
Learn more


Successfully Progressing Therapeutic Candidates from Discovery to Development Using Early Developability Assessment Tools
On Demand
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Real-Time Process Control for Healthy, High-Purity Water Systems
On Demand
Learn more



Events

Paperless Lab Academy 2018

Milano, Italy

20–21 March 2018

Making Pharmaceuticals 2018

Coventry, UK

24–25 April 2018

ACHEMA 2018

Frankfurt am Main, Germany

11–15 June 2018


more events

eBOOKS

Vaccines Development and Manufacturing 2017

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.

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