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
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
The Importance of Buffers in Downstream Processing
Industry experts provide insights on the challenges and importance of using buffers in downstream processing.
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
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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Outsourcing
CDMOs: New Administration, New Frontier
Despite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
Report: Dose CMOs Stuck in Idle
Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.
Nitto Denko Avecia Announces Manufacturing Expansion
The addition of 20,000 sq. ft. of manufacturing and office space increases Avecia’s Milford, Ma, oligonucleotide capacity to 3.0 mol.
Current Issue
Analytical Strategy in the Development of Biosimilars
The author outlines an analytical strategy for establishing similarity in biosimilar development and approval.
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
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.
Keeping it Clean: Biopharmaceutical Cleaning Validation
Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.
CPhI Biopharma News
Predictions from CPhI Annual Reports—How Accurate Were They?
The CPhI expert panel predicted in past annual reports the advancement of QbD, continuous processing, and a rise in FDA warning letters.
2017 CPhI Pharma Awards Open for Entries
The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.
Webcasts
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