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PharmTech Europe

20 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

Industry 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 Industry 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

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

Agilent

Advance the LC Characterization of Bio-therapeutics – Agilent eSeminar Series
Presented by industry experts we cover UHPLC techniques for advanced characterization of therapeutic biomolecules using state-of-the art technologies:

  • Improved Speed and Accuracy of mAb Primary Structure Characterization
  • Does N-Glycan Need to be Complicated?
  • Size Exclusion Chromatography Strategies for the Characterization of Protein Biopharmaceuticals
  • Accurate and Reliable Characterization of Impurities in Oligonucleotide Therapeutics
/ Register now and listen /

ANGUS Chemical Company

Buffers and Biochemicals for Life Sciences
Based on its exclusive nitroalkane chemistry, ANGUS Chemical Company supplies globally registered buffers and biochemicals to the life sciences industry, including TRIS AMINO® products for buffering, neutralizing, solubilizing and stabilizing.
/ Read more /

Eurofins

Bio/Pharmaceutical GMP Product Testing
Eurofins BioPharma Product Testing is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies.
/ Read More /

I Holland Ltd

Do you want to increase dwell time by 50%?
XDF (eXtended Dwell Flat) is a unique patented elliptical head from which has been designed to increase time on existing presses without the need for expensive modifications.
/ Read More /

LB Bohle

Bohle BRC dry granulator
L.B. Bohle rounds off the comprehensive offer of granulation solutions with the dry granulator series BRC 25 and 100.
/ Read More /

Müller GmbH

Stainless Steel Equipment
Product handling with system - meeting your needs in the pharmaceutical, chemical, cosmetics, food and semiconductor industries, in process plant construction and general manufacturing.
/ 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 Analytical Testing Resource Guide combo

A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
/ 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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