Pharmaceutical Technology ePT Weekly
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PharmTech
October 19, 2017
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In this issue:

Choosing Capsules: A Primer

FDA Expands Approval for J&J’s Psoriasis Biologic

Ablynx Establishes US Subsidiary, Appoints General Manager

Top Stories

FDA and Baxter Work Together to Secure Manufacturing in Puerto Rico

Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.
/ read more /


NIH Partners with Leading Biopharma Companies for Cancer Immunotherapy

NIH has entered a five-year, $215-million collaboration with leading biopharmaceutical companies to advance the development of cancer immunotherapies.
/ 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

Pfizer Considers Fate of Consumer Healthcare

The company is considering options for a full or partial separation of its Consumer Healthcare business, either through a spin-off, sale, or other transaction.
/ read more /

 

HHS Sponsors Development of Antibiotic-Resistant, Anti-Biowarfare Antibiotic

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.
/ read more /


More Industry News

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Changing the functional role of capsules in drug delivery
By combining polymer science, engineering and formulation know-how, we are creating breakthroughs in capsule and encapsulation technologies that are changing the functional role of capsules in medical research, drug formulation and drug delivery. Capsugel provides leading-edge solutions that protect high value compounds, optimize delivery to targeted sites in the body, and ensure the best operational performance in capsule filling. To learn more, visit www.capsugel.com.


Supplier News

iBio and Aethlon Medical Announce Manufacturing Collaboration

The companies will collaborate to produce and improve the recombinant properties of Aethlon’s Hemopurifier blood purification device.
/ read more /

 

Ablynx Establishes US Subsidiary, Appoints General Manager

The Belgian biopharmaceutical company has formed a subsidiary in the United States, and appointed Daniel Schneider as its general manager.
/ read more /


More Supplier News

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Bio/Pharma News

Merck KGaA Opens New Life Sciences Center

The new center will serve as a regional hub where scientists and engineers can work with customers for biological development.
/ read more /


FDA Expands Approval for J&J’s Psoriasis Biologic

The company is investing EUR 170 million (US$201 million) to expand its vaccine manufacturing site in France for its newest influenza vaccine.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Publishes Antiviral Guidance

The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.
/ read more /


EMA Updates Guidelines on Excipients in Labeling

Europe updates the guideline on excipients information in labeling and packaging.
/ read more /


More Regulatory News

FEATURED TOPICS

Drug Delivery

A Closer Look at Prefilled Syringes

Choosing between presterilized and bulk sterilized prefilled syringes.
/ read more /

Dosage Forms

Choosing Capsules: A Primer

Capsules offer certain benefits over tablets for oral-solid dosage drugs, and several types of capsules are available.
/ read more /

Quality

Automated Visual Particle Inspection

This article discusses fully automatic inspection of glass and plastic containers and factors that affect particle detection rate.
/ read more /

Analytics

Singlet Determination Revisited

Is there a difference between a specification and a standard?
/ read more /


AAPS 2017 Exhibitor Guide

CordenPharma

CordenPharma is your full-service Contract Development & Manufacturing (CDMO) partner for APIs, Drug Products, and Packaging Services.
/ Learn more /

CoreRx

CoreRx, a contract development manufacturing organization (CDMO) with a focus on clinical-phase drug product development, offering state-of-the-art facilities to support your supply chain needs throughout the entire clinical trial process.
/ Learn more /

Eurofins Lancaster Laboratories

As a member of Eurofins’ BioPharma Product Testing Group—the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide—Eurofins Lancaster Laboratories supports all functional areas of bio/pharmaceutical manufacturing.
/ Learn more /

Lonza

Lonza is a leading partner to the pharmaceutical, healthcare, and life-science industries.
/ Learn more /

Mikart, Inc.

Mikart specializes in the development, manufacturing, and packaging of solid-dose and liquid-oral dose products.
/ Learn more /

Your Preferred Preclinical CRO

MPI Research is a leading drug development CRO, providing discovery and preclinical services to the biopharmaceutical, medical device, and chemical industries.
/ Learn more /

Company Services

Patheon, a business unit of DPx Holdings B.V., is a leading provider of contract development and commercial manufacturing services to the pharmaceutical and biotechnology sectors.
/ Learn more /

Rommelag Engineering

Canisters, bottles, tubes, ampoules, drop bottles, bellows containers, and portion packaging made of polyethylene, polypropylene, or plastic blends—the scope of Rommelag’s bottelpack machines is virtually unlimited.
/ Learn more /

Shimadzu

Shimadzu is a world leader in the analytical instruments industry. Instruments include UHPLC, SFE/SFC, LC-MS/MS, GC-MS, UV-Vis, FTIR, MALDI-TOF, EDXRF, thermal analyzers, and TOC analyzers.
/ Learn more /

Thermo Fisher Scientific

Thermo Scientific™ portable analytical instruments are rugged spectrometers that deliver instant, actionable data for quick decision making in critical situations.
/ Learn more /

Unither Pharmaceuticals

Unither Pharmaceuticals is a unique development and manufacturing partner for proprietary and generic dosage forms, and a global leader in single unit dose technologies such as sterile blow-fill-seal, and liquid and powder stick-packs.
/ 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
Register now


ON DEMAND WEBCASTS

Excipient Selection to Enable the Performance of Skin Delivery Dosage Forms
On Demand
Learn more


From Candidate to Clinic: Strategies to Select, Assess, Formulate, and Deliver the Right Drug Candidate in the Early Phase
On Demand
Learn more


Enteric Capsule Technologies to Help Fast-Track Pharmaceutical Drug Development
On Demand
Learn more


Spectroscopy Advances for Improved Reproducibility and Easier Compliance
On Demand
Learn more


Packaging Material and Packaging System Quality for Pharmaceuticals and Biologics
On Demand
Learn more


Events

PDA Visual Inspection Forum

October 23–24, 2017

CPhI Worldwide

October 24–26, 2017

2017 ISPE Annual Meeting & Expo

October 29–Nov. 1, 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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