Top News

Catalent to Acquire Cook Pharmica for $950 Million

Sep 19, 2017

The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.

Alexion Restructures, Moves Headquarters, Closes Facilities, Cuts Jobs

Sep 12, 2017

Alexion’s restructuring will reduce its global workforce by 20%, including closing a manufacturing facility in Rhode Island.

FDA Approves Novartis’ CAR-T Drug, First Gene Therapy Approval in US

Aug 30, 2017

FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

Biopharma News

J&J and HHS Team Up on Flu Vaccine and Drug R&D

Sep 20, 2017

Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.

Aplagon and Cadila Collaborate on Anti-Thrombotic Biologics

Sep 19, 2017

The partners will develop a lead anti-platelet, anti-coagulant (APAC) product for treating blood vessel wall injury. Clinical trials are set for 2019 in India.

Gates Foundation Invests $40 Million in Immunotherapy Collaboration

Sep 19, 2017

The collaboration with Immunocore, a T cell receptor company, aims to discover and develop immunotherapy molecules to treat infectious diseases.

Industry News

CPhI Pharma Awards 2017 Finalists Revealed

Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 24, 2017.

FDA Sweeps Websites with Warning Letters

The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.

J&J and HHS Team Up on Flu Vaccine and Drug R&D

Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.

Supplier News

MilliporeSigma Opens First Biodevelopment Center in China

MilliporeSigma announced the opening of its first end-to-end biodevelopment center in the Asia Pacific (APAC) region.

Eurofins Scientific to Acquire EAG Labs

Eurofins Scientific has announced an agreement to acquire EAG Laboratories to expand its reach in North America.

Recipharm in Manufacturing Pact with Roche

Recipharm has announced a long-term manufacturing pact with Roche, which includes the acquisition of Roche’s solid-dose manufacturing facility in Leganés, Spain.

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

Using Simulation to Address Capacity Limitations

Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.

AstraZeneca and Champions Oncology Partner on Xenograft R&D Models

AstraZeneca and Champions will develop new cohorts of patient-derived xenograft models to be used in oncology programs in breast and lung cancer as well as for use in other academic and industry applications.

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.

Downstream Processing

Bioburden Control in the Biopharmaceutical Industry

Protecting against microbiological contaminationover the whole manufacturing process grows increasingly important.

Singular Developments Advance TFF Technology

Single-use and single-pass TFF devices are facilitating advances in biopharma manufacturing.

Acoustic Wave Separation as an Alternative to TFF

An acoustic wave-based technology for cell harvesting applications may help enable continuous manufacturing.

Standards/Regulations

FDA Sweeps Websites with Warning Letters

The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.

Wuxi Medical Instrument Factory Receives FDA Warning Letter

Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.

Manufacturers Seek Strategies for Ensuring Quality of Innovative Therapies

Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.

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

First USP Workshop of its Kind Focuses on Particulates in Biologics

Along with particulate control and determination, speakers at the June conference in Rockville, Maryland, examined the role of protein aggregation and immunogenicity

Impact of Media Components on CQAs of Monoclonal Antibodies

The authors review how media components modulate the quality of monoclonal antibody products

Glass or Plastic? Container Material Choices

Choosing a suitable material for fill/finish containers begins during the product development stage.

Formulation

mAb Generation Techniques Foster R&D Advances

The authors review methods for generating monoclonal antibodies for research and development.

Alembic Sells Indian Formulations Plant

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

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.

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

mAb Generation Techniques Foster R&D Advances

The authors review methods for generating monoclonal antibodies for research and development.

Fujifilm Opens New $9-Million Cell Culture Labs in UK

The new 10,000 ft2 of laboratories will be dedicated to the company’s monoclonal antibody platform, which enables rapid access to development and manufacturing capacity.

CPI Joins Consortium for Automated Continuous Biologics Purification

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

Vaccine Development

J&J and HHS Team Up on Flu Vaccine and Drug R&D

Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.

FDA Panel Votes Unanimously to Approve GSK Shingles Vaccine

Shingrix represents a new, possibly better alternative to existing treatments.

FDA Seizes Military Vaccine Used in Unauthorized Stem-Cell Treatments

FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.

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