Pharmaceutical Technology ePT Weekly
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PharmTech
December 5, 2019
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In this issue:

Catalent Appoints New Leadership Team

Steriline’s Robotic Nest Filling Machine
Enhances Drug R&D

West Introduces Two Elastomer Products at CPhI Worldwide 2019


Pharmacopoeia Compliance
Series

Why Pharmacopoeia Compliance Is Difficult

What is necessary for compendial compliance? Bio/pharma companies face internal and external challenges when developing and maintaining effective compliance programs. This article, the second in a series of articles, reviews an end-to-end compendial framework to help drug companies understand why compliance with pharmacopoeia standards is challenging.
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A Brief History of Pharmacopoeias: A Global Perspective

With as many as 40 different pharmacopoeias published globally, understanding the origins and purpose of these guidelines is imperative. This article, the third in a series, examines the history and evolution of the pharmacopoeias and the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias.
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Contract Service News

Fujifilm Expands Gene Therapy CDMO Capacity

Fujifilm Corporation will make a capital investment of approximately 13 billion yen (approximately $120 million USD) in the gene therapy field to further expand its contract development and manufacturing business, Fujifilm Diosynth Biotechnologies (FDB).
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Catalent Appoints New Leadership Team

Catalent has named Mike Grippo as the new senior vice president, Strategy and Corporate Development, and Julien Meissonnier as vice president and chief scientific officer.
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Hovione Technology Begins Pilot-Scale Filling of Blisters for Reusable DPI

Hovione Technology has completed pilot-scale blister manufacturing and filling for its new reusable blister-based dry powder inhaler (DPI), the Papillon DPI.
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Rentschler Biopharma Takes First Steps in US Expansion Project

Rentshler Biopharma has begun its expansion project in the United States by putting a single-use bioreactor into operation at the Milford facility in Massachusetts.
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CPhI 2019 in Review

Components Enhance High Volume Injectable Drug Delivery Systems

West introduced NovaPure 3-mL Cartridge components and the SmartDose Gen. II 10-mL injector.
/ read more /


Datwyler Launches Starter Pack with Schott

During CPhI Worldwide in Frankfurt, Germany, Datwyler launched its Starter Pack, which features its Omni Flex stoppers and Prime Caps along with Schott’s adaptiQ vials, targeted at clients looking to tackle small quantity
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Glass Syringe System Reduces Injection Force Without Silicone

Schott and W.L. Gore introduced a prefillable, silicone-free glass syringe system, which won an award at CPhI Worldwide.
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Online Tools Assist Formulation and Product Selection

Web-based digital solutions from BASF—ZoomLab, RegXcellence, and MyProductWorld—virtual assistants for drug development processes, were introduced at the CPhI Worldwide trade show in November 2019.
/ read more /


Particle Sciences Rebrands as Lubrizol Life
Science Health

Lubrizol Corporation announced that Particle Sciences, the company’s CDMO, was renamed Lubrizol Life Science Health (LLS Health), reflecting its incorporation into the new Lubrizol Life Science business group, which includes the Personal, Home, and Health Care business units.
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Recipharm Introduces New Stand-Alone Service

Recipharm, a contract development and manufacturing organization (CDMO), launched its stand-alone service, Recipharm Analytical Solutions, at CPhI Worldwide.
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Steriline’s Robotic Nest Filling Machine
Enhances Drug R&D

The company showcased its compact robotic nest filling machine at CPhI Worldwide 2019 on Nov. 5–7 in Frankfurt, Germany.
/ read more /


Thermo Fisher Scientific Expands Capabilities

Following the acquisitions of Patheon in 2017 and Brammer Bio in 2019, Thermo Fisher Scientific has invested an additional $270 million investment this year to expand its capabilities and capacity for pharma and biotech development and manufacturing, the company reported in recent press statements and meetings at CPhI Worldwide in Frankfurt, Germany.
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West Introduces Two Elastomer Products at CPhI Worldwide 2019

West Pharmaceutical Services, an injectable drug administration company based in Exton, PA, introduced its new advanced elastomer, the 4040/40 formulation, and a new line extension of its AccelTRA component program, AccelTRA Select, at CPhI Worldwide.
/ read more /


C2P Expands API Portfolio

Luxembourg-based company, C2 Pharma (C2P), has expanded its API and botanical extracts product portfolio with digoxin micronized grade and homatropine hydrobromide, and has multiple products under tech transfer and in development.
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Sterling Pharma Solutions Invests into US Expansion

Contract development and manufacturing organization (CDMO), Sterling Pharma Solutions, has revealed its investment of $1.5 million into a phased expansion of its facility based in North Carolina, United States.
/ read more /


Gerresheimer Renovates Glass
Production Facility

Gerresheimer completed a modernization of its plant in Essen, Germany, including renovation of its clear-glass furnace used to produce glass containers for the pharmaceutical industry.
/ read more /

ON DEMAND WEBCASTS


How to Approach Preparative LC for Compound Purification in the Research and Development Laboratory
On Demand
Learn More


A Roadmap for Early Development to Commercial Manufacturing
On Demand
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Replacing Settle Plates with Active Air Sampling
On Demand
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An Integrated Approach to Spray Drying: From Scale-Up to Manufacturing
On Demand
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Events

Computer Systems Validation & Data Integrity Compliance Congress

December 9–11, 2019

SMi Group’s 12th Annual Conference and Exhibition: Pre-Filled Syringes and Injectable Drug Devices 2020

January 15–16, 2020

SMi’s 9th Annual Pharmaceutical Microbiology Conference

January 20–21, 2020


more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2019

The editors explore 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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