Pharmaceutical Technology ePT Weekly
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PharmTech
October 11, 2018
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In this issue:

Planning a Successful MES Deployment

FDA Approves New Drug for Bacterial Lung Disease

MHRA Seeks Views on 'No-Deal' Brexit Legislation and Procedural Changes


Top Stories

Janssen, Arrowhead Enter $3.7-Billion Partnership to Treat Hep B

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.
/ read more /


Protecting Antibody IP: Consider Regional Differences

Biotechnology developers should be aware of subtle differences between the way that European and US patent authorities approach monoclonal antibodies.
/ read more /

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Industry News

University College London and Pall Biotech Open Research and Training Center

The UCL-Pall Biotech Centre of Excellence will address industry challenges and provide workforce training.
/ read more /


Meet the 2018 CPhI Pharma Awards Winners

This year's awards attracted more than 250 entries, which included innovations in products and service offerings from across the bio/pharmaceutical supply chain and honored companies and individuals driving the industry forward.
/ read more /


More Industry News
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Supplier News

Medherant Receives Grant from Innovate UK for Transdermal Patch Manufacturing

Funding from Innovate UK will be used by Medherant to support manufacture of transdermal patches for clinical trials.
/ read more /


Catalent Invests $7.3 Million in Aprilia, Italy Facility

The investment includes an upgrade and expansion of the company's packaging and softgel encapsulation capabilities at its facility in Aprilia, Italy.
/ read more /


More Supplier News
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Bio/Pharma News

Merck, Dragonfly Therapeutics to Collaborate on Solid-Tumor Immunotherapies

The companies will work together to discover, develop, and commercialize immunotherapies for patients with solid-tumor cancers in a collaboration worth $695 million per program.
/ read more /


GSK, Hitachi Chemical in T-Cell Manufacturing Pact

The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline's specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.
/ read more /


More Bio/Pharma News
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Ensure you are up to date on the latest regulations and have the tools to navigate market approvals in the field of advanced therapy by attending the 2018 PDA Cell and Gene Therapy Conference, Oct. 23-24. In less than two weeks, industry and regulatory experts will share insight on topics, including the progress of gene editing, regulatory considerations for development and commercialization, and lifecycle management.
Register now!


Regulatory News

FDA Approves New Drug for Bacterial Lung Disease

Insmed's Arikayce (amikacin liposome inhalation suspension) is the first drug approved under the agency's Limited Population Pathway for Antibacterial and Antifungal Drugs, established to support development of antibiotics for unmet medical needs.
/ read more /


 

MHRA Seeks Views on 'No-Deal' Brexit Legislation and Procedural Changes

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a 'no-deal' Brexit scenario.
/ read more /


More Regulatory News

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Attend our upcoming webinar on Tuesday, October 23, 2018 at 11 am EDT on Sterility Testing: Best Practices and Use of Isolator Technology. Learn strategies and best practices for maximizing the conditions of a sterility test environment, as well as reducing the risk of inaccurate results for sterility testing through the use of isolators and vaporized hydrogen peroxide (VHP).
Register now to save your seat.

FEATURED TOPICS

VACCINES

Modern Manufacturing Key to More Effective Vaccines

Accelerated development of new preventives raises challenges for CMC evaluation and production.
/ read more /

FACILITIES

Modular Facility Design Maximizes Space Flexibly

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.
/ read more /


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MANUFACTURING

Planning a Successful MES Deployment

Preventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.
/ read more /

FINISHED PRODUCT ANALYSIS

PharmTech Q&A Series: Measuring Elemental Impurities in Pharmaceuticals with Rob Thomas, Part 1

In this three-part podcast series, Rob Thomas, principal consultant at Scientific Solutions, discusses the impetus behind his book, Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide.
/ read more /


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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry. Learn More


UPCOMING WEBCASTS

Insoluble APIs Scaring You? Don't be Afraid of Nanoparticles!
Wednesday, October 31, 2018 at 11am EDT|8am PDT|3pm GMT|4pm CET
Register now


Planning Successful Launches of Complex Drug Products
Tuesday, October 30, 2018 at 11am EDT|8am PDT|3pm GMT|4pm CET
Register now


Sterility Testing: Best Practices and Use of Isolator Technology
Tuesday, October 23, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


Successfully Navigating the Analytical Environment of Complex Generic APIs
Tuesday, October 16, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


Implementing Transmission Raman for Fast Content Uniformity Testing – from Feasibility Evaluation to a Validated Release Method
Europe: Thursday, October 11, 2018 at 2pm BST/ 3pm CEST
North America: Thursday, October 11, 2018 at 11am EDT/ 8am PDT/ 10am CDT
Register now


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ON DEMAND WEBCASTS

Facing Inactive Ingredient Database Challenges? Navigating the Complexity for Successful Regulatory Filings
On Demand
Learn more


Moving Beyond the Central Dogma: New Tools and Systems for the Production of Difficult-to-Express Proteins
On Demand
Learn more


Assessing Product Integrity Risk Profiles and Engineering On-Dose Authentication During Drug Development Process
On Demand
Learn more


Events

Healthcare Packaging EXPO

October 14–17, 2018

scwish:pharma

November 1–2, 2018

ISPE Annual Meeting & Expo

November 4–7, 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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