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PharmTech Europe
22 August 2017

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Top Stories

GSK Opens $57-Million Vaccines Facility in UK

GSK opened a new vaccine manufacturing facility in Montrose, Scotland. The facility will be used to manufacture aluminum salts, which are used for vaccine production.
/ read more /


Trek Therapeutics to Test Blockchain-Based Smart Contracts for Clinical Supply Chain Safety

Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.
/ read more /

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Industry News

Amneal Pharmaceuticals Recalls Lorazepam Oral Concentrate

The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.
/ read more /


ICH Announces Training Program

A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
/ read more /


More Industry News

Regulatory News

EMA Increases Support for SMEs

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.
/ read more /


Canadian Manufacturer Receives FDA Warning Letter

The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company's Toronto facility.
/ read more /


More Regulatory News


Bio/Pharma News

Regeneron Halts Development of RSV Biologic

The antibody therapeutic failed to meet its primary endpoint in a Phase III study.
/ read more /


Pfizer Plans Gene Therapy Manufacturing Investment in North Carolina

Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.
/ read more /


More Bio/Pharma News

Supplier News

Avara Buys Sterile Manufacturing Facility from Pfizer

The acquisition adds sterile manufacturing capability to the CDMO's services, which include API formulation and manufacturing.
/ read more /


Cambrex Adds HPAPI Capacity

Cambrex is investing $24 Million in new, highly potent API manufacturing capacity at its Charles City, Iowa site.
/ read more /


More Supplier News

TOP COUNTRY FOR PHARMA?

What Country Ranks Highest in Pharma Manufacturing?

CPhI survey seeks industry input to rank top-performing nations on pharma manufacturing and business factors.

CPhI Worldwide, a sister company to Pharmaceutical Technology, is conducting a global ranking of the top 10 pharmaceutical countries to assess reputations in API production, finished dosage formulations, growth potential, innovation, regulatory acumen, and other factors.

The survey invites participants to share opinions about the performance and reputations of the United Kingdom, France, Italy, Germany, India, the United States, Japan, China, Korea, and Spain. The survey also measures market competitiveness, business growth, transparency, and pharma knowledge.

A summary of the compiled results will be available on www.PharmTech.com. Complete results will be published on the CPhI Pharma Insights webpage.
/ Pharma industry professionals are invited to take the 12-minute survey via this link. /


FEATURED TOPICS

MANUFACTURING

Using QbD in Topical Drug Manufacturing

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
/ read more /

 

QUALITY

Avoiding Investigational Failure/Discrepancy-Related Form 483 Observations

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
/ read more /

ANALYTICS

A Continuous Improvement Metric for Pharmaceutical Manufacturing

Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
/ read more /

BIOLOGICS

Optimizing Cell-Culture Media

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.
/ read more /


Product Profile

Rommelag AG

Bottelpack aseptic processing
Bottelpack machines allow primary packaging for a wide variety of formulations including inhalation solutions, ophthalmics and parenterals.
/ Read more/


Event Profile

CPhI Worldwide 2017

Date: 24-26 October 2017
Venue: Messe Frankfurt, Germany
CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, hosts more than 42,000 visiting pharma professionals over three days. 2,500+ exhibitors from 153 countries gather at the event to network and take advantage of more than 150 free industry seminars. The exhibition covers every sector of the pharmaceutical market under one roof.
/ Read more/


UPCOMING WEBCASTS

Ensure the Scalability of Your Molecule with a Science-Driven, Phase-Appropriate Approach
Live Webcast: Tuesday, August 29 at 10:00am EDT
Register now


Using Health-Based Exposure Limits (HBELs) to Assess Risk
Live Webcast: Wednesday, September 6 at 11:00am EDT
Register now


No-Fuss Continued Process Verification: Automating Process and Product Monitoring
Live Webcast: Thursday, September 14 at 11:00am EDT
Register now


ON DEMAND WEBCAST

Implementing Risk Strategies for the Pharmaceutical Supply Chain
On Demand
Learn more


Events

CPhI Korea

Seoul, Korea

22–24 August 2017

Workshop on Continuous Pharmaceutical Manufacturing: From Powder to the Coated Tablet

Ennigerloh, Germany

19–21 September 2017


more events

Reference Library

Pharmaceutical Technology Solid Dosage Combo

Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
/ Click here /


More Reference BookS

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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