Pharmaceutical Technology ePT Weekly
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PharmTech
March 21, 2019
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In this issue:

Common Blueprint for Protein Antibiotics

Embracing the Digital Factory for Manufacturing

FDA Publishes Guidance on Drug Effectiveness


Top Stories

Novartis Changes Sandoz Leadership, Sandoz CEO Steps Down

Richard Francis will step down as CEO of Sandoz, effective March 31, 2019.
/ read more /


'No-Deal' Brexit: Chemistry Professionals Overwhelmingly Concerned, Notes Survey

A new survey, commissioned by the Royal Society of Chemistry, has highlighted the level of concern within the UK's chemistry sector surrounding the potential 'no-deal' Brexit outcome.
/ read more /

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INTERPHEX 2019 KEYNOTE SERIES

Continuous Manufacturing and 3D Printing
At INTERPHEX 2019, experts will discuss strategies for bringing continuous manufacturing to commercial scale. Plus, learn how 3D printing technology is being used in bio/pharma applications.

LEARN MORE

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Industry News

Mylan Institutional LLC Recalls Levoleucovorin Injection

The company is recalling Levoleucovorin Injection, 250 mg/25 mL because of copper salts found during stability testing.
/ read more /


Scientists Discover Common Blueprint for Protein Antibiotics

Findings from the Los Angeles Biomedical Research Institute could enable a new generation of anti-infectives.
/ read more /


More Industry News
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Supplier News

Cambrex Completes Expansion and Manufacturing Capability Upgrades in Milan

The expansion includes a new R&D laboratory and the installation of a 12,000-liter reactor at one of the company's manufacturing facilities on its Paullo site in Milan, Italy.
/ read more /


Ajinomoto Bio-Pharma Services Expands Services

A $100-million investment will expand a range of the CDMO's service capabilities and offerings.
/ read more /


More Supplier News
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Bio/Pharma News

Ono Pharmaceutical, twoXAR Collaborate on Drug Discovery Research

The companies announced a collaboration to jointly discover and develop treatments to address unmet medical needs in a specific neurological disease.
/ read more /


AbCellera is Funded $4.8 Million for Vaccine and Antibody Research

The company received $4.8 million from the Bill & Melinda Gates Foundation to accelerate global health research in the development of vaccines and antibody-based treatments for infectious diseases.
/ read more /


More Bio/Pharma News
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The new RA816 Biological Analyser
The Renishaw RA816 Biological Analyser is a compact benchtop Raman imaging system, designed exclusively for biological and clinical research. Use the RA816 Biological Analyser to identify and assess biochemical changes associated with disease formation and progression. There is little to no sample preparation, and no contrast agents or tags are needed.
Read more



Regulatory News

Hospira Facility in India Receives Warning Letter

FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.
/ read more /

FDA Publishes Guidance on Drug Effectiveness

The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.
/ read more /


More Regulatory News
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The pharma industry – defined.
Experience the long-standing expertise of CPhI with the convergence of pharma's most motivated buyers, experienced sellers, in addition to an array of networking opportunities at CPhI North America – happening April 30 – May 2, 2019 in Chicago, Illinois. Register now to walk our strategically zoned Expo Hall for free!
Click here to register for free.


FEATURED TOPICS

MANUFACTURING

Embracing the Digital Factory for Bio/Pharma Manufacturing

New technologies in the digital factory enhance quality, efficiency, and flexibility for bio/pharmaceutical manufacturing.
/ read more /

REGULATORY/GMP COMPLIANCE

Reinterpreting Benchmarks for Innovative Therapies

While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma's adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.
/ read more /

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Exclusive Interview from AAPS 2018
Cutting Edge Formulations in Topic Drug Development
Watch Video


FORMULATION

Rising to the Challenge of Biologic Drug Formulation

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.
/ read more /

PEER-REVIEWED RESEARCH

Real-Time Measurement of Coating Film Thickness

Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
/ read more /

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2019 BIO International Convention
June 3-6, 2019 | Philadelphia, PA
As the world's largest global biotechnology partnering event, the BIO International Convention (#BIO2019) is the one event where you can access 16,000+ attendees from 67 countries, network and set up meetings via BIO One-on-One Partnering™, and attend 150+ education sessions. Discover the next generation of cutting-edge products, therapies, and cures all week long.
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TAKE THE SURVEY

Biopharmaceutical Manufacturing Survey

Participate in BioPlan's 16th Annual Global Biopharmaceutical Manufacturing Study. Share your insight on current global and regional trends affecting biomanufacturing and receive a free aggregated summary of this year's results and an updated Top Trends in Biopharmaceutical Manufacturing White Paper. If you complete, the survey, BioPlan will donate $15 (up to $3000) on your behalf to global health charities or you can receive a $15 Amazon e-gift card.
Take the survey


UPCOMING WEBCASTs

Approaches to Analyze and Understand 1–100 µm Particles/Aggregates in Biotherapeutics
Tuesday, April 23, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


Formulation Development for Scalability: Manufacturing Strategies for Bioavailability-Enhancing Technologies
Wednesday, April 3, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Capsugel® Vcaps® Plus: The New Standard in HPMC Capsules
Thursday, March 28, 2019 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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Ensuring Integrity of Drug Formulation from Development to QC
Wednesday, March 27, 2019 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
Register now


ON DEMAND WEBCASTS

Benefits of Using High-Functionality Excipients in a Continuous Process
On Demand
Learn More


Top 4 Quality Trends for 2019
Pharma Quality Outlook Survey

On Demand
Learn More


Events

DCAT Week '19

March 18–21, 2019

INTERPHEX

April 2–4, 2019

World Vaccine Congress

April 14–17, 2019

more events

eBOOKS

Laboratory Best Practices 2018 eBook

The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing.


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