Pharmaceutical Technology ePT Weekly
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PharmTech
March 28, 2019
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In this issue:

Alcami Announces Biologics Enterprise

Strategic Screening for Solubility Solutions

FDA Issues Guidance on HIV-1 PrEP Products


Top Stories

Thermo Fisher Scientific to Acquire Brammer Bio

A $1.7-billion acquisition of CDMO Brammer Bio establishes Thermo Fisher Scientific in viral vector manufacturing.
/ read more /


EMA Answers Brexit Questions

The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.
/ read more /

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INTERPHEX 2019 KEYNOTE SERIES

Bioprocessing Capacity Challenges
How is the industry meeting capacity demands for biologic-based drugs? Experts discuss ways to address production-related challenges.

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Industry News

Pharmaceutical Jewelry Could Offer a New Family Planning Approach

Researchers at the Georgia Institute of Technology developed a technique for administering contraceptive hormones through 'pharmaceutical jewelry'.
/ read more /


Valitacell, Solentim Funded for Biologics and Cell Therapy Development

Valitacell, Solentim, and Microcoat were awarded EUR 3.5 million (US$4 million) to produce an integrated platform to deposit, culture, profile, and select optimal cells for biologic drug manufacturing.
/ read more /


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Supplier News

Alcami Announces Biologics Enterprise

Alcami Biologics formed to meet market demands for biological drug development services.
/ read more /


Catalent Invests in Zydis Ultra Commercialization

Catalent announces investment for its Zydis ODT technology, offering increased drug load and taste-masking capabilities.
/ read more /


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Bio/Pharma News

Merck KGaA Opens Development Center in France and Invests in Darmstadt Headquarters

Merck KGaA opened a collaborative bio/pharma development facility in Molsheim, France and announced an investment plan through 2025 for its Darmstadt, Germany headquarters.
/ read more /


Lilly and ImmuNext Announce Licensing and Research Collaboration

Worth up to $605 million, the collaboration will focus on studying a preclinical novel target that could lead to potential new treatments for autoimmune diseases.
/ read more /


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Exclusive Interview from AAPS 2018
Cutting Edge Formulations in Topic Drug Development
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Regulatory News

FDA Issues Guidance on HIV-1 PrEP Products

The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.
/ read more /

FDA Provides Guidance on Natural History Studies for Rare Disease Treatment

The guidance provides industry with information on the design and implementation of natural history studies to support the development of treatments for rare diseases.
/ 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!
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FEATURED TOPICS

ANALYTICS

Key Considerations in Stability Testing

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.
/ read more /

DOSAGE FORMS

Assuring the Safe Handling of Potent APIs, Intermediates, and Solid-Dosage Drugs

Containment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.
/ read more /

OUTSOURCING

Monoplant: Advantages of a Dedicated Facility

A monoplant may offer greater supply security and flexibility for specialist medicines.
/ read more /

EXCIPIENTS

Strategic Screening for Solubility Solutions

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.
/ read more /


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.
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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
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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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ON DEMAND WEBCASTS

Ensuring Integrity of Drug Formulation from Development to QC
On Demand
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Benefits of Using High-Functionality Excipients in a Continuous Process
On Demand
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Top 4 Quality Trends for 2019
Pharma Quality Outlook Survey

On Demand
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Events

INTERPHEX

April 2–4, 2019

World Vaccine Congress

April 14–17, 2019

CPhI North America

April 30–May 2, 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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