Top News

FDA Approves First-of-its-Kind RNA Therapy

Aug 13, 2018

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

EMA Scales Back Activities to Prepare for Brexit

Aug 09, 2018

The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.

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.

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

Emergent to Acquire Specialty Vaccines Company PaxVax

Aug 17, 2018

The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.

Astellas Acquires Gene Therapy Company Quethera

Aug 17, 2018

The acquisition will strengthen Astellas Pharma’s position in ophthalmology.

Pfizer, BioNTech to Develop mRNA-based Flu Vaccines

Aug 16, 2018

The companies entered a multi-year R&D collaboration to develop mRNA-based flu vaccines.

Industry News

First Generic Version of EpiPen Gets Approval

FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.

Repeat Quality Deviations Found at India Facility

FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.

FDA Grants Support Research in Modernizing Pharmaceutical Manufacturing

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.

Supplier News

Emergent to Acquire Specialty Vaccines Company PaxVax

The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.

FDA Approves Drug Product Manufacturing for Samsung BioLogics

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

Joseph Polli Named AAPS President-Elect

Pharmaceutical scientist association announces upcoming term’s board of directors.

Upstream Processing

Maintaining Cell Line Integrity

The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.

The Search for Next-Gen Expression Systems

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

Optimizing Late-Stage and Commercial Cell-Culture Processes

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

Downstream Processing

Expectations for Residual Impurity Analysis Continue to Rise

More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.

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.

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.

Sponsored Videos

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QbD and PAT in Biopharmaceutical Development
In this eBook, learn how the adoption of QbD and Process Analytical Technology (PAT) as well as Design of Experiments techniques help biopharmaceutical companies improve efficiency and accelerate time to market. 
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Cell and Gene Therapies

Key Biologics and Astarte Biologics Merge

The combined companies will provide research- and clinical-grade human immune cells, blood products, and related services.

Avalon GloboCare Partners with Weill Cornell Medical College for CAR-T Production Technologies

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.

Boehringer Ingelheim Licenses Global Rights to Cystic Fibrosis Gene Therapy

Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.

Analytics

ARM Releases Second-Quarter Report on Regenerative Medicines Sector

The Alliance for Regenerative Medicine’s (ARM) report highlights major trends and metrics from the 2018 second quarter in the regenerative medicines sector.

E&L Risk Assessment for Biologic Drug Products

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.

Expectations for Residual Impurity Analysis Continue to Rise

More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.

Formulation

The Search for Next-Gen Expression Systems

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

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.

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

Maintaining Cell Line Integrity

The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.

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.

Vaccine Development

Emergent to Acquire Specialty Vaccines Company PaxVax

The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.

Pfizer, BioNTech to Develop mRNA-based Flu Vaccines

The companies entered a multi-year R&D collaboration to develop mRNA-based flu vaccines.

Ebola Vaccinations Begin in Response to Congo’s Last Outbreak

Ebola vaccinations by the World Health Organization began in North Kivu, Democratic Republic of the Congo, one week after the country’s latest outbreak.

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