Pharmaceutical Technology ePT Weekly
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PharmTech
June 21, 2018
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In this issue:

CMOs Expand Manufacturing Capacities

Micromeritics Acquires Freeman Technology

Identifying TPPs and CQAs for a Lyophilized Parenteral Product


Top Stories

Sanofi Completes $4.8-Billion Ablynx Acquisition

The acquisition is expected to strengthen Sanofi’s R&D strategy with Ablynx’s nanobody technology platform.
/ read more /


Roche to Acquire Foundation Medicine for $2.4 Billion

The acquisition is expected to strengthen Roche’s personalized healthcare strategy.
/ read more /


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Industry News

New Innovation Center in Scotland Aims to Revolutionize Medicines Manufacturing

The new industry-led Medicines Manufacturing Innovation Center (MMIC) will offer a unique service to develop and implement novel manufacturing techniques.
/ read more /


Domestic Pharma Industry Drives Machinery Demands at P-MEC China

Intelligent manufacturing and environmental policies are key trends at P-MEC 2018.
/ read more /


More Industry News
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Supplier News

Micromeritics Acquires Freeman Technology

The acquisition expands Micromeritics’ portfolio of products and solutions.
/ read more /


CFDA Approves Drug Developed with CDMO Support

WuXi STA supported the development of hepatitis drug through marketing authorization holder pilot program.
/ read more /


More Supplier News
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New USP Certificate of Pharmacopeial Quality Assessment
Trust USP to create a comprehensive and robust certificate program to guide your career path to new heights. This new certificate was created by some of the leading minds in quality assessment, the very scientists who have contributed to the development of the trusted USP–NF standards used all over the world. Information on USP Certificate Program


Bio/Pharma News

Celltrion Resubmits to FDA Its Proposed Biosimilar to Roche’s Herceptin

The company has resubmitted a biologics license application to FDA for its proposed biosimilar to Roche’s Herceptin.
/ read more /


J&J Accepts $2.1-Billion Offer for Diabetes Solutions Business

Johnson & Johnson has accepted an offer from Platinum Equity to acquire diabetes solutions business LifeScan for $2.1 billion.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Commissioner Outlines Agency's Efforts for Patient-Focused Drug Development

FDA Commissioner Scott Gottlieb, MD, released a statement on new agency efforts to involve the patient voice in medical product development and FDA regulatory decision-making.
/ read more /


Congress Presses FDA to Do More to Combat Drug Shortages

Legislators have requested that FDA do more to prevent drug shortages.
/ read more /


More Regulatory News

FEATURED TOPICS

QUALITY SYSTEMS

Identifying TPPs and CQAs for a Lyophilized Parenteral Product

Quality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.
/ read more /

OUTSOURCING OUTLOOK

CMOs Expand Manufacturing Capacities

New and expanded facilities point to the continuing growth of the biopharmaceutical industry.
/ read more /

PEER-REVIEWED RESEARCH

A Study of the Effects of Histogram Binning on the Accuracy and Precision of Particle Sizing Measurements

This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.
/ read more /

FORMULATION

An Alternative to Pills and Injections: CUREfilm Redefines How Medicines are Delivered and Experienced

The CUREfilm technology delivers drugs through a dissolvable strip that can be applied in the oral cavity or onto the skin.
/ read more /


UPCOMING WEBCASTS

Building a Faster, More Flexible Biologic Development Process for Targeted Therapies
Tuesday, July 31, 2018 at 10am EDT | 3pm BST | 4pm CEST
Register now


Multiparticulate Formulation Strategies for Pediatric Drugs
Thursday, July 12, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Engineering and Manufacture of Second Generation ADCs: Tools and Techniques
Wednesday, June 27, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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ON DEMAND WEBCASTS

A Rational Approach to Excipient Selection
On Demand
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E&L and Beyond: Qualifying Plastic Materials for Contaminants and Failure
On Demand
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Continuous Processing in Biomanufacturing Considerations for Adoption and Case Studies in Biologic Development and Manufacturing
On Demand
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How to Package Highly Complex Biologics
On Demand
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The Pharma Supply Chain Revolution
On Demand
Learn more


Events

DCAT Sharp Sourcing 2018

June 26, 2018

MES 2018:13th Annual Global Forum on Manufacturing Execution Systems

August 13–14, 2018

4th Annual Data Integrity Validation

August 15–16, 2018


more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2018

This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.

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