Former FDA Commissioner Gottlieb Rejoins VC Firm

Scott Gottlieb, who recently stepped down as the head of the U.S. FDA, has rejoined venture capital firm New Enterprise Associates as a full-time investing partner. Gottlieb had been a venture partner with NEA for 10 years before President Trump tapped him to lead the FDA. He's expected to lead investments in life sciences startups and take board seats on behalf of the firm. Gottlieb also recently rejoined the American Enterprise Institute as a resident scholar, and he plans to maintain that position. Alert readers will recall that Mr. Gottlieb resigned abruptly from his leadership position at the FDA just months ago. Learn More

Sun Pharma to Develop Branded Medicines

After a four-year decline that erased 65% from the value of Sun Pharma, comes word that the world's biggest generic drug manufacture will pursue branded drugs. That won't be easy, especially when the multinationals that dominate the pharmaceutical business have already seen the payoffs from their massive research and development spending become more uncertain. Those giants are increasingly turning to acquisitions to fill out their pipelines, and that's where Sun Pharma sees an opening. Sun Pharma thinks the company can eventually pick up enough early-stage innovations and key personnel to generate half its revenue from patented medicines. Learn More

Boehringer Ingelheim Investing $84M to Expand Operations in Mexico

Boehringer Ingelheim has announced a multi-million-dollar investment that will see the expansion of its manufacturing capacity in Mexico over the next two years. The majority of the investment, $52 million will be at the biopharma giants site in Xochimilco which specializes in oral dosage anti-diabetic drugs. The Xochimilco plant is one of three sites that Boehringer has in Mexico, and the capital injection will be destined to increase the production capacity by at least 50%. The expansion at the Xochimilco plant is part of an investment plan to invest $84 million by 2023 to boost production at all three of its production sites in the country. Learn More

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Former FDA Commissioner Gottlieb Rejoins VC Firm

Scott Gottlieb, who recently stepped down as the head of the U.S. FDA, has rejoined venture capital firm New Enterprise Associates as a full-time investing partner. Gottlieb had been a venture partner with NEA for 10 years before President Trump tapped him to lead the FDA. He's expected to lead investments in life sciences startups and take board seats on behalf of the firm. Gottlieb also recently rejoined the American Enterprise Institute as a resident scholar, and he plans to maintain that position. Alert readers will recall that Mr. Gottlieb resigned abruptly from his leadership position at the FDA just a few months ago. Learn More

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Predicting the Stability of Monoclonal Antibodies at High Concentration Formulations

Monoclonal antibodies (mAbs) used as therapeutics often require formulation at high concentrations to minimize administration volume. High concentration poses an increased risk of instability, primarily via complicated aggregation pathways. Identification of consistently reliable tools to predict longer term stability based on initial data remains a challenge in the biotech industry, especially in the context of protein aggregation. Aggregation is influenced by both colloidal and conformational stability.  In this work, we evaluate the ability of these methods to predict the long-term aggregation for a series of mAbs based on their intrinsic molecular properties.

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We successfully use Roche in our PD group but need to find a bioprocess analyzer with similar functionality that has proven itself well suited for manufacturing scale mammalian cell culture. Also, I’m going to need to validate the instrument to ensure GMP compliance. Any suggestions?

While there are numerous bioprocess analyzers, each with its own strengths and weaknesses, the requirement that the instrument be well suited for not just manufacturing scale mammalian cell culture, but proven GMP compliance, greatly reduces the available options. That being said, I would suggest you take a look at the BioProfile Flex 2 from Nova Biomedical.

BioProfile FLEX2

Introduction to Viral Safety

This video provides insight into the reality of viral contamination and serves as an introduction to the principles and practices associated with viral safety.

Previous Survey Results
Have you had an experience where bubbles have adversely affected your bioprocess?
Please comment on the reason(s). %

Participant Comment
"Sample collection, DO probe shift, disruption in harvest"

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Webinar: Innovative Direct Dispense Technology to Ensure In-Time Delivery and Release During Continuous Biomanufacturing

Tuesday, June 4th, 2019

In biologic manufacturing, caking is a phenomenon that can affect a wide range of hygroscopic solid raw materials and excipients. Apart from the sourcing and logistics considerations for these materials and the direct costs related to caking, lost batches due to unreliable product supply, inconsistent product quality or inconsistent product release are other challenges that companies must overcome.

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Function of Liver Cancer Genes in Mini-Organs

Researchers from the Hubrecht Institute and Radboud University have developed a human model in which they use organoids, or mini organs, to study the function of specific genes that are mutated in liver cancer. Using this method, they have found that mutations in BAP1, a gene commonly mutated in liver cancer, changes the behavior of the cells, which may make them more likely to be invasive. Since the model makes it relatively straightforward to manipulate healthy human organoids with CRISPR/Cas9, it may be used to study the function of the many genes with unknown function in liver cancer. Their results were published this week in the scientific journal Cell Stem Cell. Learn More

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Bioreactor with Condenser

A U.S. Patent for a "Bioreactor with Condenser" was awarded to Sartorius Stedim on May 21st, 2019. The present invention is a bioreactor with a vessel having at least one gas dissipation duct for gas discharge, the orifice of the gas dissipation duct being connected to a hydrophobic sterile filter and to a condenser arranged between them and having condensation surfaces, a turbulence generator for generating a turbulent flow is arranged in the gas dissipation duct in the region of the condenser. Learn More

1883 Brooklyn Bridge Opens

On this day in 1883, after 14 years of construction the Brooklyn Bridge over the East River is opened connecting Manhattan and Brooklyn. Learn More

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Need a New Idea? Start at the Edge of What is Known

"Where do great ideas come from?" Starting with this question in mind, Vittorio Loreto takes us on a journey to explore a possible mathematical scheme that explains the birth of the new. Learn more about the "adjacent possible" -- the crossroads of what's actual and what's possible -- and how studying the math that drives it could explain how we create new ideas. Learn More

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Chugai Consolidating R&D Into New $1B+ Facility

Chugai, a business unit of Roche, announced this week a decision to construct a centralized research laboratory. The new facility, to be known as the Chugai Life Science Park, is being constructed in Yokohama. The new facility will become home to both the Fuji Gotemba Research Laboratories and Kamakura Research Laboratories upon its completion. As for the future of the two research labs, both will be closed after the consolidation is complete. The new 380,000 sq. ft. facility is expected to cost roughly $1.15B with construction scheduled to begin in August of this year and be completed in Q3' 2022. Learn More

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The Portuguese Introduced a Battered and Fried Green Bean Recipe to Japan known as Peixinhos da Horta in the 1500’s

It has become the Japanese dietary staple known as tempura.  Learn More