Pharmaceutical Technology ePT Weekly
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PharmTech
June 14, 2018
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In this issue:

Meeting the EU Serialization Deadline

Emerging Technologies Advance Oral Drug Delivery

Sartorius Stedim Biotech, Siemens Collaborate on Automation


Top Stories

Bayer Completes Monsanto Acquisition for $63 Billion

Bayer completed its acquisition of Monsanto, the largest in Bayer’s history.
/ read more /


Gilead Sciences, Hookipa in $410-Million Partnership for HIV, Hepatitis B Immunotherapies

The companies will partner in research for HIV and hepatitis B immunotherapies, and Hookipa will manufacture arenavirus-based vectors for clinical development by Gilead.
/ read more /


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Industry News

Report Shows Bioscience Industry Has $2-Trillion Economic Impact

A new report released at the BIO International Convention shows that the US bioscience industry has had a $2-trillion economic impact and has accelerated venture capital investment and job growth.
/ read more /


AMRI Secures Seven-Year NIH Contract for APIs and Drug Product

Under the contract, AMRI will focus on the development and manufacture of APIs and drug product for Phase I clinical studies.
/ read more /



More Industry News
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Supplier News

Sartorius Stedim Biotech, Siemens Collaborate on Automation

Siemens will become a preferred supplier for Sartorius Stedim Biotech’s automation solutions, and SSB will create a globally standardized automation platform for its biopharmaceutical manufacturing systems.
/ read more /

 

Vetter Launches Use-Centered Approach to Improve Injections

Vetter announced the Open Innovation Challenge to examine the applicability of digital trends to injection systems.
/ read more /


More Supplier News
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Bio/Pharma News

GE Healthcare Equips China Cell Therapy Manufacturing Plant with FlexFactory

The company will provide the first FlexFactory manufacturing platform for TCR T-cell therapy manufacturing.
/ read more /

 

Alexion, Complement Partner to Treat Neurodegenerative Disorders

Alexion Pharmaceuticals and Complement Pharma will partner to develop a preclinical C6 complement inhibitor to treat neurodegenerative disorders.
/ read more /


More Bio/Pharma News

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At the 2018 PDA/FDA Joint Regulatory Conference, Sept. 24-26 in Washington, DC, industry experts and U.S. FDA regulators will explore the circumstances that impact the quality, safety, and availability of drugs. Gain new perspectives and best practices on the evolving regulatory landscape, supply chain risks, quality culture, and challenges in manufacturing.
Register by Jul. 16 and save up to 400!

Regulatory News

FDA Launches Overhaul of New Drug Review Program

The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
/ read more /

 

Global Standard for Managing Post-Approval Changes Moves Forward

Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.
/ read more /


More Regulatory News

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IVT's Stability Testing Europe allows attendees to review core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing. Don't miss the chance to participate in hands-on training for small molecules, biologics and medical devices to harmonize global systems and enhance stability programmes.
Learn more

 

FEATURED TOPICS

DRUG DELIVERY

Emerging Technologies Advance Oral Drug Delivery

New approaches enable more patient-centric drug design that offers improved outcomes.
/ read more /

ASEPTIC/STERILE PROCESSING

Identifying Contamination: Subvisible Particle Imaging

Flow imaging microscopy can be used to identify particulates and their sources.
/ read more /

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As the landscape continues to face an influx of regulations surrounding the reliability, consistency and accuracy of analytical methods and data, it is critical for the biopharmaceutical industry to adhere to new regulatory expectations.
Analytical Procedures & Methods Validation Europe provides a comprehensive understanding of regulatory trends and requirements, "hands-on" training for executing procedures that survive the lifecycle and solutions to challenges within the laboratory.
Learn more

MANUFACTURING

New Tools Outline Advances for Continuous API Processing

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.
/ read more /

REGULATORY/GMP COMPLIANCE

Meeting the EU Serialization Deadline

Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline.
/ read more /


UPCOMING WEBCASTS

Engineering and Manufacture of Second Generation ADCs: Tools and Techniques
Wednesday, June 27, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


A Rational Approach to Excipient Selection
Wednesday, June 20, 2018 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST
Register now


E&L and Beyond: Qualifying Plastic Materials for Contaminants and Failure
North America: Tuesday, June 19, 2018 at 11am EDT | 10am CDT | 8am PDT
Europe: Tuesday, June 26, 2018 at 9am BST | 10am CEST
Register now


Continuous Processing in Biomanufacturing Considerations for Adoption and Case Studies in Biologic Development and Manufacturing
Thursday, June 14, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


ON DEMAND WEBCASTS

How to Package Highly Complex Biologics
On Demand
Learn more


The Pharma Supply Chain Revolution
On Demand
Learn more


Events

ACHEMA 2018

June 11–15, 2018

American Biomanufacturing Summit 2018

June 14–15, 2018

Philadelphia Adents Serialization Innovation Summit

June 20–21, 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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