Top News

Celltrion’s Biosimilar to Remicade Likely to be Approved for All Indications

Feb 09, 2016

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

Pfizer Announces Organizational Changes for Pending Allergan Merger

Feb 09, 2016

Pfizer names executive leadership team for combined organization upon close of proposed Allergan transaction.

Valeant and Turing Called Out on Drug Pricing

Feb 04, 2016

In a hearing held on Feb. 4, 2016, executives from Valeant and Turing had a hard time explaining their rationales for exorbitant price hikes of older drugs.

Biopharma News

Pfizer Announces Organizational Changes for Pending Allergan Merger

Feb 09, 2016

Pfizer names executive leadership team for combined organization upon close of proposed Allergan transaction.

Danish Companies and University Collaborate on MRSA Vaccine

Feb 08, 2016

Barvarian Nordic, Evaxion Biotech, and the Technical University of Denmark announced plans to collaborate on the development of a vaccine for MRSA.

FDA Staff Backs Remicade Biosimilar

Feb 08, 2016

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

Industry News

Danish Companies and University Collaborate on MRSA Vaccine

Barvarian Nordic, Evaxion Biotech, and the Technical University of Denmark announced plans to collaborate on the development of a vaccine for MRSA.

FDA Staff Backs Remicade Biosimilar

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

Valeant and Turing Called Out on Drug Pricing

In a hearing held on Feb. 4, 2016, executives from Valeant and Turing had a hard time explaining their rationales for exorbitant price hikes of older drugs.

Supplier News

LabConnect Builds New Biorepository Facility

LabConnect built a biorepository facility in Tennessee.

Novasep Adds Small-Scale Manufacturing Capability to US Facility

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

SCIEX and the Bioprocessing Technology Institute Announce Partnership

The partnership will focus on the identification and analysis of host-cell proteins in biologics.

CPhI Biopharma News

Ompi Presents Alternative Sterilization Method for Biologics

The process provides an alternative to the sterilization of cartridges and vials with ethylene oxide (EtO).

Avantor Debuts New Packaging Platform for Dry Powder Products

Avantor released a packaging platform that allows for the direct dispensing of chemicals—such as salts, buffers, and cell culture ingredients—into processing equipment.

Upstream Processing

Complementary Techniques for the Detection and Elucidation of Protein Aggregation

In this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.

Use of an E. coli pgi Knockout Strain as a Plasmid Producer

The authors describe the impact of the knocking of the pgi gene of the wild type MG1655 strain on the growth kinetics of plasmid-free and plasmid-bearing cells.

Antibody Production in Microbial Hosts

The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.

Downstream Processing

Going Small to Achieve Success on the Commercial Scale

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

Precipitation as an Alternative to Chromatography in the Insulin Manufacturing Process

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.

Bespoke Bioprocessing Resins

BioPharm International sat down with Kevin Isett, PhD, co-founder and CEO of Avitide, to find out why he thinks the company’s tailored approach to purification resins will change the face of biopharmaceutical separation.

Formulation

Complementary Techniques for the Detection and Elucidation of Protein Aggregation

In this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.

Intertek Explores the Reformulation of Intravenous Biologics

The company plans to reformulate injectable products to make them into inhaled and intranasal medications.

Reformulating to Gain Downstream Processing Efficiency

A new consortium involving Arecor, Fujifilm Diosynth Biotechnologies, and the UK's Center for Process Innovation will focus on formulation innovation as a way to improve downstream processing and reduce biopharmaceutical cost.

Peer-Review Research

Precipitation as an Alternative to Chromatography in the Insulin Manufacturing Process

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.

Variable Pathlength Fiber-Optic Spectrophotometry for Protein Determination in Immunoglobulin Concentrates

The authors evaluate the SoloVPE technique as a replacement for nitrogen-based protein determination.

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Standards/Regulations

FDA Staff Backs Remicade Biosimilar

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

Immunomedics Receives Breakthrough Therapy Designation for Breast Cancer Antibody-Drug Conjugate

FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.

Innovative Therapies Require Modern Manufacturing Systems

FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.

Analytics

The Emerging View of Endotoxin as an IIRMI

The recognition that microbial artifacts are capable of modulating the mammalian immune system is an emerging view of biologic drug contamination control testing.

Failure Mode Effects Analysis for Filter Integrity Testing

Understanding of the risks associated with FMEA is crucial in lot release testing.

Fine Tuning the Focus on Biopharma Analytical Studies

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

Single-Use Systems

GE Healthcare Delivers Modular Biopharma Facility to China

GE Healthcare's KUBio prebuilt modules were shipped from Germany to JHL Biotech in Wuhan, China.

Univercells Partners with Takeda to Develop Vaccine Manufacturing

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

Automation of Single-Use Systems

The automation trend in single-use applications serves to increase process robustness and reduce variability.

mAb Development

Antibody Production in Microbial Hosts

The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.

mAbs to Watch in 2016

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

BioInvent to License Novel Antibody

The company will in-license a novel antibody, which has a conformation that is associated with increased therapeutic efficacy.

Vaccine Development

Seqirus Opens Corporate Headquarters in the United Kingdom

Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.

FDA Convenes to Discuss Use of Maternal Vaccination to Promote Infant Health

Panelists at the meeting will focus on clinical trial design, immunogenicity, and enhancing implementation plans for administering already-licensed vaccines to this patient population.

Pfizer Transfers Vaccine Technology for Production in South Africa

South Africa’s Biovac Institute, which develops and produces vaccines for the country, launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.

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