Top News

Congress Meets Deadline for Reauthorizing FDA User Fees

Aug 08, 2017

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.

Merck and Pfizer Collaborate with Corning to Modernize Pharmaceutical Glass Packaging

Jul 21, 2017

A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.

Endo Withdraws Opioid Drug from Market

Jul 10, 2017

After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.

Biopharma News

Shire Announces Director and Senior Management Changes

Aug 21, 2017

Shire announced that CFO Jeff Poulton will be leaving the company at the end of the year. Additionally, Joanne Cordeiro has been appointed as CHRO.

Samsung Bioepis Partners with Takeda to Develop Novel Biologics

Aug 21, 2017

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

Biocon Withdraws Breast Cancer Biosimilar Filings in Europe

Aug 18, 2017

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

Industry News

CDER, CBER, and CDRH Directors Praise FDARA Reauthorization

The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.

FDA Releases Supply Chain Guidance

The agency published guidance on identifying trading partners under DSCSA.

ISPE European Conference Announces Pharma 4.0

The International Society for Pharmaceutical Engineering (ISPE) announced its Europe Pharma 4.0 Conference, taking place November 23 – 24, 2017 in Verona, Italy.

Supplier News

Axol Bioscience Gets $3-Million Capital Investment

The private equity funding will enable the startup biotech firm to expand product development as well as sales and marketing capabilities.

Cancer Genetics to Acquire Australian CRO

The $12-million acquisition will strengthen Cancer Genetics Inc.’s (CGI) capabilities in drug discovery, drug development, and early phase clinical trial testing in the field of oncology.

SGS Expands Bioanalytics Capacity

The expansion at its Lincolnshire, IL, facility will double the footprint of the site’s range of services, including microbiological evaluation, drug stability studies, and medical devices testing.

Trends in Bioprocessing

Perfusion in the 21st Century

By Bruce Lehr, Delia Lyons

Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.

The Importance of Buffers in Downstream Processing

By Susan Haigney

Industry experts provide insights on the challenges and importance of using buffers in downstream processing.

Designing a Biomanufacturing Facility Incorporating Single-Use Technologies

By Peter Genest, John Joseph

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

BioPharm eBooks

Outsourcing Resources
Nearly 60% of the bio/pharma companies responding to a recent BioPharm International survey outsource at least half of their crucial development and manufacturing tasks. In this ebook, the editors report on the biopharma–contract services relationship.   
View ebook

 

 

Upstream Processing

Samsung Bioepis Partners with Takeda to Develop Novel Biologics

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

The Role of Quality Standards for Biomanufacturing Raw Materials

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Optimizing Cell-Culture Media

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.

Downstream Processing

Process Chromatography: Continuous Optimization

Improved resin chemistries and customized separation solutions are enabling more efficient separations.

Just the Biopharma Facts, Please

Amid debate about “fake news,” peer-review papers offer vital, objective insight.

Best Practices for Data Integrity

Optimize practices and meet requirements using electronic data integrity systems.  

Standards/Regulations

CDER, CBER, and CDRH Directors Praise FDARA Reauthorization

The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.

FDA Releases Supply Chain Guidance

The agency published guidance on identifying trading partners under DSCSA.

Canadian Manufacturer Receives FDA Warning Letter

The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.

Videos

Sponsored Videos

Sponsored eBooks

Advances in Biopharmaceutical Characterization: Charge Variants and Aggregates
Experts discuss overcoming the challenges of developing mAb formulations using novel pH gradient methods for ion exchange chromatography that provide fast and reproducible mAb charge variant profiling. View eBook

 

 

A Journey Through the Protein Purification Workflow
Experts share best practices for downstream purification, and how continuous purification methods can offer increased productivity and greater process reliability and reproducibility in the laboratory and when scaling protein purification processes for the production of commercial quantities. View eBook

 

Fundamental UHPLC Workflows for Biotherapeutic Characterization
The introduction of UHPLC revolutionized bio/pharma analytical laboratories and advances in technology promise more for the future. In this e-book, experts explain recent advances in UHPLC, and the basics of glycan analysis. View eBook

Analytics

SGS Expands Bioanalytics Capacity

The expansion at its Lincolnshire, IL, facility will double the footprint of the site’s range of services, including microbiological evaluation, drug stability studies, and medical devices testing.

Analytical Strategy in the Development of Biosimilars

The author outlines an analytical strategy for establishing similarity in biosimilar development and approval.

The Role of Quality Standards for Biomanufacturing Raw Materials

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Formulation

The Role of Quality Standards for Biomanufacturing Raw Materials

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Optimizing Cell-Culture Media

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.

Catalent and Rutgers University to Study Pediatric Drug Challenges

Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.

Single-Use Systems

Process Chromatography: Continuous Optimization

Improved resin chemistries and customized separation solutions are enabling more efficient separations.

Larger Peristaltic Pumps Allow Scale-Up for Biopharm Projects

Higher-flow peristaltic pumps from Watson-Marlow Fluid Technology Group are designed for upstream and downstream bioprocessing with single-use fluid path assemblies.

ABEC Releases 4000-L Single-Use Bioreactor

ABEC increases the maximum capacity of its Custom Single Run Bioreactors to 4000 L, doubling the industry standard.

mAb Development

Process Chromatography: Continuous Optimization

Improved resin chemistries and customized separation solutions are enabling more efficient separations.

FDA Accepts Application for Teva’s Herceptin Biosimilar

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

Horizon Discovery Releases CHO Genome Sequence for Bioproduction

Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.

Vaccine Development

Merck KGaA and Baylor Partner on Vaccines for Neglected Diseases

Through its life-sciences business, MilliporeSigma, Merck KGaA will collaborate with Baylor College of Medicine to advance vaccine development for neglected and emerging diseases.

FDA Extends Dynavax’s Hep B Vaccine Review

FDA requests more detailed information on a post-marketing study for Dynavax’s hep-B vaccine, which will require an extended review time past its August 2017 PDUFA date.

Janssen, Bavarian Nordic Partner on Hep B and HIV Vaccines

Partnership aims to develop new vaccine regimens against hep B and HIV by combining respective proprietary vaccine technologies.

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