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PharmTech Europe

13 October 2015

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Adaptimmune Opens New Facility
FDA Releases Guidance on Labeling
A Case for Solid Dispersions

Top Stories

New Study Reveals Immunotherapy More Effective Than Chemotherapy

The results from an international study on nivolumab, published in the New England Journal of Medicine, suggest a paradigm shift in the standard of care for previously treated lung cancer patients.
/ read more /


Nobel Prize Awarded for Parasitic Disease Drug Development Efforts

Researchers in the US, Japan, and China are recognized for developing therapies to combat river blindness, lymphatic filariasis, and malaria.
/ read more /


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Bio/Pharma News

Adaptimmune to Open New R&D Facility in Oxfordshire, UK

The new facility will house the company’s expanding R&D operations.
/ read more /


Probiodrug Signs Manufacturing Agreement with Rentschler for Monoclonal Antibody PBD-C06

Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development and production of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer’s disease.
/ read more /


More Bio/Pharma News
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Supplier News

Merck Millipore Adds Protein Pegylation Services

Merck Millipore’s collaboration with celares GmbH launches pegylation services for protein-based therapeutics.
/ read more /


Impel and 3M Partner to Advance Olfactory Drug Delivery

3M and Impel will collaborate to develop and commercialize Impel’s Precision Olfactory Delivery technology for enhanced central nervous system drug delivery.
/ read more /


More Supplier News

Regulatory News

FDA Releases Guidance on Labeling

The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.
/ read more /


FDA Plans Pilot Projects for Drug Supply Chain Security Act

FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.
/ read more /


More Regulatory News

Industry News

Cell Therapy Catapult Launches Cell History File

The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.
/ read more /


 

PDA Releases Report on Passive Thermal Protection Systems

The PDA report discusses qualification and operational handling of passive thermal protection systems.
/ read more /


More Industry News

FEATURED TOPICS

OUTSOURCING

Cost Inhibits CMO Adoption of Single-Use Equipment

The high cost of disposables is a factor in restricting adoption of single-use devices.
/ read more /

STANDARDS AND REGULATIONS

FDA Faces Controversy Over Quality Metrics and Biosimilars

Manufacturers challenge details in new policies designed to promote access to important therapies.
/ read more /

ANALYTICS

PAT Paves the Way for Continuous Manufacturing

Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.
/ read more /

FORMULATION

A Case for Solid Dispersions

Experts from Dow Pharma & Food Solutions discuss the versatility of solid dispersions in solubility enhancement and the importance of pairing the API to the optimal polymer.
/ read more /


Product/Service Profiles

ABITEC Corporation

CAPMUL® — Where Formulation Begins™
ABITEC's CAPMUL bioavailability enhancers are medium-chain mono- and di-glycerides and propylene glycol esters. These functional lipid excipients act as solubilizers and emulsifiers in oral, topical, transdermal, and parenteral drug delivery systems.
/ Read More /

EtQ Inc

The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
In a market where high-demand causes organizations to seek software systems that will fit into their complex business infrastructure, the pressure to find the right system often causes angst to many.
Learn some key elements to spotting a good FDA Compliance solution, techniques for achieving Good Manufacturing Practice (GMP) Compliance, and how to ensure that Quality and Compliance are met in the Life Science industry.
/ Download Guidebook Now /

Gerresheimer AG

Gerresheimer Group
Gerresheimer is a leading global partner to the pharma and healthcare industries. The company’s special glass and plastic products contribute to health and well-being.
/ Read More /

L B Bohle

Bohle Coating – Bohle Film Coater BFC
The BFC is the high-end version of the Bohle coater designed specifically for high speed, problem-free coating, providing unparalleled tablet uniformity and efficiencies. A high containment execution is also available.
/ Read More /

Shimadzu

The Swiss Knife of analytics
Shimadzu has released its new Nexera UC unified chromatography system. It is the world’s first-ever unified and fully automated instrument combining supercritical fluid extraction (SFE) with supercritical fluid chromatography (SFC).
/ Read More /

Umicore

High Potency APIs
Umicore is one of the largest producers of platinum APIs for anti-cancer treatment. We pride ourselves in having decades of experience in platinum group metals chemistry and high potency APIs.
/ Read More /

VAI

Cleanroom Documentation Systems
Introducing VAI’s Cleanroom Documentation Systems, the Core2Print, Core2Write, and CleanPrint 10 that address the problem of documentation materials that shed fibers or particulates in aseptic GMP operations.
/ Read More /

Wickham Laboratories Ltd

MALDI-ToF Rapid Microbial Identification
GMP/GLP compliant testing laboratory, Wickham Laboratories Ltd, announces the introduction of new MALDI-ToF, rapid microbial identification service.
/ Read More /


Event Profile

CPhI India

Meet 32,000 Pharma Professionals @South Asia's largest Pharma Expo
1st – 3rd December 2015
Bombay Convention & Exhibition Centre, Mumbai, India
/ Learn more /


Webcasts

Controlling Contamination in Biopharmaceutical Manufacturing

On Demand

In this webcast, experts will review the sources of contamination, regulations and guidance documents on the control of potential contaminants in raw materials, and best practices to guard against the introduction of contaminants in the manufacturing process. The challenges of detecting contaminants, including mycoplasma, assay development, and testing practices will be discussed.
Sponsored by SGS Life Science Services


Trends in Quality Agreements & Communications: A CMO Perspective

On Demand
This webinar, led by Milton Boyer, senior vice-president of drug product manufacturing at AMRI, will review and challenge the changing paradigms in the CMO­/drug sponsor relationship. It is clear that both CMOs and drug sponsors are being held responsible for the actions of the other. Responsibilities once thought to be clearly defined are changing, with new guidance and expectations revealed in 483s and FDA warning letters.
Sponsored by AMRI


more webcasts

on pharmtech tv

PharmTech TV

Trends and Concerns in Capsule Production

Application of External Lubrication in Tablet Production

Contract Services Market Trends

Events

2015 AAPS Annual Meeting

October 25–29, 2015 | Orlando, FL, USA

21st Annual Validation Week

October 27–29, 2015 | Philadelphia, PA

Stability Testing

December 08–10, 2015 | Philadelphia, PA


more events

REFERENCE LIBRARY

Pharmaceutical Technology presents its Process Analytical Technology resource guide combo

A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
/ Click here /


More Reference Library

eBOOKS

Bioprocessing and Sterile Manufacturing 2015 eBook

This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.

more ebooks
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