Pharmaceutical Technology ePT Weekly
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PharmTech
June 7, 2018
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In this issue:

Fujifilm Opens Collaboration Center

Data Integrity Failures Found at China Facility

Albumin Attachment Can Make Better Biobetters


Top Stories

FDA Approves First Biosimilar to Amgen’s Neulasta

The agency has approved Mylan's Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen's Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.
/ read more /


EMA Recommends Four Biosimilars for Approval

The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie's Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche's Herceptin.
/ read more /


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Industry News

Ingenza in Collaboration to Recycle CO2 from Bioprocessing Plants

Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.
/ read more /


AAPS Announces 2018 Slate of Candidates

The American Association of Pharmaceutical Scientists (AAPS) board of directors announced the candidates for the 2018 AAPS board.
/ read more /



More Industry News
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Supplier News

Fujifilm Opens Collaboration Center

FUJIFILM Diosynth Biotechnologies opens Cambridge, MA center to promote collaboration with biotech companies.
/ read more /

 

Lonza to Manufacture TxCell Product

TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.
/ read more /


More Supplier News
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Bio/Pharma News

Anti-methamphetamine Antibody Moves to Clinic

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.
/ read more /

 

GE and CCRM Partner with DiscGenics on New Cell Therapy

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.
/ read more /


More Bio/Pharma News

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Regulatory News

FDA Releases REMS Guidance

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.
/ read more /

 

Data Integrity Failures Found at China Facility

FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.
/ read more /


More Regulatory News

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FEATURED TOPICS

ASEPTIC/STERILE

Lies That Environmental Monitoring Systems Tell

Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?
/ read more /

DRUG DEVELOPMENT

Albumin Attachment Can Make Better Biobetters

Naturally occurring and engineered albumins are being explored as a tool to enhance the stability of drugs, including biologics, and extend shelf-life.
/ read more /

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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.
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PROCESS VALIDATION

Understanding Validation and Technical Transfer

Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
/ read more /

MANUFACTURING

Impact of Agitator Design on Bioreactor Performance

Aerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.
/ 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.
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UPCOMING WEBCASTS

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
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The Pharma Supply Chain Revolution
On Demand
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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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