FDA Finalizes ‘Biological Product’ Definition Ahead of BPCIA Transition

A month before the long-anticipated transition of applications for certain biological products to be deemed to be licensed as biologics, the US FDA has issued a final rule amending its definition of "biological product." Effectively, on March 23rd, 2020, some 100 products approved under new drug applications (NDAs) will transition to biologics license applications (BLAs). Under the rule, the FDA is amending its definition of "biological product" in line with the statutory definition set by the BPCIA. As such, the FDA now interprets the term "protein" to mean "any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size." Learn More

Gilead Loses 2nd Patent Fight with HHS, Sending Dispute to Federal Court

For the second time this month Gilead has suffered a loss in its high-profile feud with the US Government. Following a similar decision earlier this month, the U.S. Patent & Trademark Office's Patent Trial and Appeal Board decided not to strike up inter partes reviews (IPR) of patents held by the U.S. government. Gilead had challenged the patents in August, but for the second time this month, the board decided Gilead wouldn't be likely to succeed. Gilead "has not demonstrated a reasonable likelihood that it would prevail with respect to at least one of the claims," the PTAB said in its ruling. Alert readers will recall that the courts have demonstrated some aversion to ruling against the USPTO. Learn More

U.S. FDA Revokes ‘Voluntary Action Initiated’ Status for Aurobindo’s Hyderabad Unit

The U.S. FDA revoked the 'Voluntary Action Initiated' status issued to Aurobindo Pharma's plant in Hyderabad, days after indicating it might not pursue further regulatory action. The company has received a communication from the U.S. regulatory agency that the inspection conducted at its unit-IV - a general injectable formulation plant - "is still open and under review by way of rescindment of 90-day VAI letter", according to an exchange filing. This notification comes just days after Aurobindo informed the stock exchanges that it has received the VAI status-allowing the company to make voluntary changes to the unit if needed and shielding it from any adverse action by the regulator. Learn More

FDA Finalizes ‘Biological Product’ Definition Ahead of BPCIA Transition

A month before the long-anticipated transition of applications for certain biological products to be deemed to be licensed as biologics, the US FDA has issued a final rule amending its definition of "biological product." Effectively, on March 23rd, 2020, some 100 products approved under new drug applications (NDAs) will transition to biologics license applications (BLAs). Under the rule, the FDA is amending its definition of "biological product" in line with the statutory definition set by the BPCIA. As such, the FDA now interprets the term "protein" to mean "any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size." Learn More

Assessment of Recombinant Protein Production in E. Coli with Time-Gated Surface Enhanced Raman Spectroscopy (TG-SERS)

Time-Gated Surface-Enhanced Raman spectroscopy (TG-SERS) was utilized to assess recombinant protein production in Escherichia coli. TG-SERS suppressed the fluorescence signal from the biomolecules in the bacteria and the culture media. Characteristic protein signatures at different time points of the cell cultivation were observed and compared to conventional continuous wave (CW)-Raman with SERS. TG-SERS can distinguish discrete features of proteins such as the secondary structures and is therefore indicative of folding or unfolding of the protein. A novel method utilizing nanofibrillar cellulose as a stabilizing agent for nanoparticles and bacterial cells was used for the first time... Learn More

I need to monitor cell density in a mini-bioreactor and do not have a headplate port available. Any suggestions?

I recently came across the miniBE from Buglab which I think addresses your application. It is a non-invasive solution which attaches to the wall of your mini-bioreactor and monitors cell density. A unique feature of this product is that the sensor can be reused and the system itself is capable of being multiplexed to several vessels. Here is a link to more information.

miniBE

Enhancing Automated Sampling, Process Monitoring and Nutrient Feedback Control for a System of 3L Bioreactors

In a recent typical experiment, eight bioreactors were sampled three times per day with feedback control for multiple separate nutrient feed solutions per vessel, based upon independent metabolite triggers. Over the course of the run each vessel was triggered feeds 35-40 times with feed volumes ranging from 2 to 40 mL for over 300 automated feeds across the eight vessels. Refined data extraction templates streamlined data imports and the electronic notebook system, and PI integration can enable remote monitoring. The enhanced system capabilities are being increasingly leveraged to support ongoing process development efforts.

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The G-CON/Vanrx East Coast Roadshow Tour

Friday, April 3rd - Tuesday, April 21st, 2020

What if isolator filling lines were ordered fully integrated, fully qualified, installed in their fully integrated and qualified surrounding classified environment, all with guaranteed functionality? Well, this need has become a reality. Come see the first and only turnkey facility for aseptic filling of advanced therapies, Microcell POD.

Attendees will have the opportunity to:

  • Discuss the paradigm shift in biopharma filling solutions
  • Learn the features and benefits of Microcell POD
  • Speak with G-CON and Vanrx sales and engineering experts
  • Tour a live example of the Microcell POD

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Physics Tool Helps Track Cancer Cell Diversity

A Cornell-led team took a novel, interdisciplinary approach to analyzing the behavior of breast tumor cells by employing a statistical modeling technique more commonly used in physics and economics. The team was able to demonstrate how the diversity, or heterogeneity, of cancer cells can be influenced by their chemical environment -- namely, by interactions with a specific protein, which leads to tumor growth. The researchers' paper, "Lymphoidal Chemokine CCL19 Promoted the Heterogeneity of the Breast Tumor Cell Motility Within a 3D Microenvironment Revealed by a Lévy Distribution Analysis," published Feb. 14 in Integrative Biology. Learn More

Bioreactors with Multiple or Adjustable-Position Agitator Designs

A U.S. Patent for "Bioreactors with Multiple or Adjustable-Position Agitator Designs" was awarded to Genentech on February 18th, 2020. The present invention described herein are bioreactor support structures configured to be used with containers having different designs, and methods for making and using such bioreactors. The support structures described herein may include two or more agitator motors and control systems or an adjustable-position agitator motor, a removable spacer and/or lid, multiple configurations for ports and probes, and multiple exhaust filter heating blankets... Learn More

1988 Supreme Court Defends Right to Satirize Public Figures

On this day in 1988, the U.S. Supreme Court votes 8-0 to overturn the $200,000 settlement awarded to the Reverend Jerry Falwell for his emotional distress at being parodied in Hustler, a pornographic magazine. The high court ruled that the parody fell within the First Amendment's protection of freedom of speech and the press. Learn More

How to Keep Human Bias Out of AI

AI algorithms make important decisions about you all the time -- like how much you should pay for car insurance or whether or not you get that job interview. But what happens when these machines are built with human bias coded into their systems? Technologist Kriti Sharma explores how the lack of diversity in tech is creeping into our AI, offering three ways we can start making more ethical algorithms. Learn More

WuXi Vaccines to Build Additional Biologics Manufacturing Facility

WuXi Vaccines has announced that it has entered into a strategic partnership with a global vaccine leader and signed a 20-year vaccine manufacturing contract valued approximately $3 billion. As part of the deal WuXi will build an integrated vaccine manufacturing facility including drug substance manufacturing (DS), drug product manufacturing (DP), Manufacture Science and Technology Labs (MS&T) as well as Quality Control labs (QC). The facility will be dedicated to manufacture one of its partner's vaccine products for the global market. The new facility is expected to be operational in 2022. Learn More

Roses are Planted at the End of a Row of Grape Vines on Vineyards Because They are Very Susceptible to Powdery Mildew and Mold

As such, they act as an early warning sign of mold or mildew allowing the vineyard staff to react before it impacts the grapes. Learn More