Pharmaceutical Technology ePT Weekly
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PharmTech
October 12, 2017
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In this issue:

Storm Impact on Drug Supply

Making Decisions Based on Risk

GE Healthcare Opens 3D-Printing Lab

Top Stories

Pharma's Role in Puerto Rico's Future

Reeling from financial and tropical storms, Puerto Rico needs stable industry for recovery.
/ read more /


Bavarian Nordic Secures BARDA Contract for Smallpox Vaccine

The Danish biotechnology company has been awarded a sole-source BARDA contract valued at more than $539 million for a freeze-dried smallpox vaccine.
/ read more /

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PharmTech 2017 Employment Trends

The editors of Pharmaceutical Technology invite you to participate in the annual employment survey for individuals involved in bio/pharmaceutical development, formulation, or manufacturing.

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Industry News

MediLedger to Explore Use of Blockchain for DSCSA Compliance

Genentech, AmerisourceBergen, and McKesson are providing pharma user requirements for a new project that will evaluate blockchain's potential in meeting requirements of the Drug Supply Chain Security Act, and preventing pharmaceutical counterfeiting.
/ read more /

 

Storm Impact on Drug Supply

FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.
/ read more /


More Industry News
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Supplier News

GE Healthcare Opens 3D-Printing Lab

GE Healthcare opened a 3D printing lab in Sweden that will speed the launch of products for bio/pharma manufacturing, such as a custom chromatography column.
/ read more /

 

G-Con and IPS to Collaborate on Turnkey Modular Projects

The iCON brand aims to offer flexible, rapidly deployable systems for biopharmaceutical manufacturing.
/ read more /


More Supplier News

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The 2017 PDA Cell and Gene Therapy Conference will address one of the hottest and fastest growing areas of pharmaceutical manufacturing! At this Conference, learn how industry is applying novel approaches for development and commercialization of bio/pharmaceutical products. Sessions will focus on current and future applications for these innovative therapeutics, including the emerging fields of immunotherapy, next-generation manufacturing, and application of big data for process design.
Learn more and register!


Bio/Pharma News

Celgene and Nimbus Partner for Autoimmune Disorders

The alliance gives Celgene an option to acquire programs run by Nimbus Therapeutics for developing therapeutics to treat autoimmune disorders.
/ read more /

 

BARDA Funds Ebola Vaccine and Drug Development

Under Project BioShield, the agency could provide more than $170 million in funding to purchase and support late-stage development of Ebola vaccines and therapeutic drugs.
/ read more /


More Bio/Pharma News

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We want to hear from YOU! Participate in the Quality Management Priorities and Goals Survey. First 50 respondents receive a $5 gift card – All respondents can enter to win one of two $150 gift cards.
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Regulatory News

FDA and EMA Announce Updates to Adverse Event Reporting Systems

Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.
/ read more /

 

FDA User Fees Promote Manufacturing Readiness

Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
/ read more /


More Regulatory News

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FEATURED TOPICS

Process Validation

Cleaning Validation for APIs

The industry needs a single standard cleaning limit at 25 mg/m2.
/ read more /

Outsourcing

Up and Away, M&A

Mergers and acquisitions are positive for the CDMO industry, but there is a downside.
/ read more /

Standards & Regulations

Making Decisions Based on Risk

Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
/ read more /

Formulation

Managing Potentially Potent APIs

CDMOs have established strategies for handling new chemical entities with unknown biological activity.
/ read more /


AAPS 2017 Exhibitor Guide

Alcami

Alcami is a world-class supplier of comprehensive pharmaceutical development and manufacturing services headquartered in Wilmington, NC.
/ Learn more /

Ascendia Pharmaceuticals

Ascendia is a speciality CDMO dedicated to developing enhanced formulations for poorly water-soluble molecules.
/ Learn more /

Ashland Inc.

Delivering pharmaceutical and nutraceutical performance, Ashland provides solutions for applications in tablet binding, film coating and disintegration, controlled-release formulation and drug solubilization.
/ Learn more /

Associates of Cape Cod, Inc.

Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 40 years.
/ Learn more /

Intelligent Dose Design

Catalent has multiple tools and technologies to assist in the development of innovative dose forms that can improve a drug's clinical efficacy and its commercial success.
/ Learn more /

Chemic Laboratories

Chemic Laboratories, Inc. is a full-service cGMP/GLP contract analytical chemistry laboratory.
/ Learn more /

Coating Place

Coating Place develops and manufactures modified release oral products. We are the leading provider of Wurster microencapsulation.
/ Learn more /

Colorcon

Colorcon® is a world leader in the development, supply and technical support of formulated film coating systems, modified release technologies, and functional excipients for the pharmaceutical and nutritional industries.
/ Learn more /


UPCOMING WEBCASTS

Challenges in the Development of Complex Small-Molecule Drugs
Live Webcast: Tuesday, November 7 at 11:00am EST
Register now


Analytical Challenges in Extractables Studies of Plastic Single-Use Bioprocess Bags
Live Webcast: Tuesday, October 31 at 11:00am EDT
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Excipient Selection to Enable the Performance of Skin Delivery Dosage Forms
Live Webcast: Wednesday, October 18 at 11:00am EDT
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ON DEMAND WEBCASTS

From Candidate to Clinic: Strategies to Select, Assess, Formulate, and Deliver the Right Drug Candidate in the Early Phase
On Demand
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Enteric Capsule Technologies to Help Fast-Track Pharmaceutical Drug Development
On Demand
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Spectroscopy Advances for Improved Reproducibility and Easier Compliance
On Demand
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Packaging Material and Packaging System Quality for Pharmaceuticals and Biologics
On Demand
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No-Fuss Continued Process Verification: Automating Process and Product Monitoring
On Demand
Learn more


Emerging Pharma’s Winning Combination: A Science-First Approach to Accelerating Drug Development
On Demand
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Formulation Selection and in-vitro Screening for Oral Bioavailability Enhancement
On Demand
Learn more


Events

Rare Diseases & Orphan Products Breakthrough Summit

October 16–17, 2017

Speed to IND for Biologics

October 19–20, 2017

PDA Visual Inspection Forum

October 23–24, 2017

more events

eBOOKS

Biologics and Sterile Manufacturing

New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.


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