Top News

FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays

Jul 19, 2018

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

Jul 19, 2018

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

Jul 12, 2018

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

BioPharm eBooks

Single-Use Systems 2018 eBook
A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs. 

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Biopharma News

FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays

Jul 19, 2018

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

Jul 19, 2018

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

Novartis, CELLforCURE Partner to Manufacture CAR-T Therapies

Jul 18, 2018

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

Industry News

FDA Forms Drug Shortages Task Force

FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.

FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

FDA Sends Warning Letter to California OTC Manufacturer

Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.

Supplier News

Novartis, CELLforCURE Partner to Manufacture CAR-T Therapies

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

Hydroxyapatite Chromotography Media Offers Enhanced Biomolecule Purification

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.

Otsuka to Acquire Visterra for $430 Million

Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.

Upstream Processing

Optimizing Late-Stage and Commercial Cell-Culture Processes

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

Biopharma Seeks Balance

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Comparing the Supply Lifecycle of Bioreactors

Understanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type.

Downstream Processing

The Challenge of Disruptive Technologies in Bioprocessing

Increasing demand for biologics is driving the need for innovation in bioprocessing.

Biopharma Seeks Balance

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Purolite Launches New Protein A Resin

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

Standards/Regulations

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

CGMP Violations Found at India Facility

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With

President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.

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QbD and PAT in Biopharmaceutical Development
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Cell and Gene Therapies

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

Novartis, CELLforCURE Partner to Manufacture CAR-T Therapies

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Analytics

FDA Invites Comment on New Exposure Limits for Cadmium

FDA and ICH seek comment on new exposure levels for cadmium in drug products.

Advances in Analytics for Bioprocessing

Process analytical technology tools have enabled manufacturers to monitor and control their production processes.

Biopharma Seeks Balance

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Formulation

Ionic Pill Could Replace Daily Injections for Diabetics

A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.

Single-Use Boosts Fill/Finish in Commercial Biomanufacturing

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

Biosimilars and Biobetters Strategies and Challenges

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

Single-Use Systems

Entegris Acquires Flex Concepts

The acquisition of Flex Concepts adds custom, single-use products to Entegris’ single-use bag product line.

Single-Use Boosts Fill/Finish in Commercial Biomanufacturing

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

Assurance of Supply

Robust materials management, supplier quality management, quality control, and business continuity planning are essential to ensure continuous supply of single-use bags.

mAb Development

Hydroxyapatite Chromotography Media Offers Enhanced Biomolecule Purification

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.

Optimizing Late-Stage and Commercial Cell-Culture Processes

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

The Challenge of Disruptive Technologies in Bioprocessing

Increasing demand for biologics is driving the need for innovation in bioprocessing.

Vaccine Development

Sanofi Pasteur, Translate Bio in $805-Million Deal to Develop mRNA-Based Vaccines

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

Research Shows Promise for Syphilis Vaccine

Microbiologists from the University of Connecticut have pinpointed exterior proteins on syphilis-causing bacteria that could serve as vaccine targets for syphilis.

New Research Hub Tackles Access to Vaccines

The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.

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