Top News

Novartis to Sell Parts of Sandoz in $1-Billion Deal

Sep 06, 2018

Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.

DHSC Directs Pharma to Stockpile Medicines

Aug 23, 2018

As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.

UK Outlines Potential Pharma Changes Post-Brexit

Aug 23, 2018

Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.

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

Avara Acquires Sterile Manufacturing Facility from Sandoz

Sep 14, 2018

Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.

Gilead, Precision BioSciences to Develop Therapies Against Hep B

Sep 14, 2018

The companies will develop therapies targeting the in-vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform.

Sanofi Partners with Dyadic to Research Fungus-Based Expression Platform

Sep 10, 2018

The collaboration will explore the potential of Dyadic’s gene-expression platform to produce multiple biologic vaccines and drugs.

Industry News

Experts Suggest Trade and Patent Changes Could Increase Healthcare Cost by $100 Billion

In the second half of CPhI’s annual report, experts review industry trends and warn that trade and patent changes could increase healthcare cost by $100 billion over the next five years.

Sterile Manufacturing Issues found at Canadian Manufacturer

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.

Additional Impurity Found in Valsartan

FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.

Supplier News

Roquette Showcases Biopharma Innovations at CPhI Worldwide 2018

The provider of plant-based ingredients will present recently launched multi-compendial materials for upstream and downstream biopharmaceutical applications.

Avara Acquires Sterile Manufacturing Facility from Sandoz

Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.

Pall and Aetos Biologics Partner on Biosimilar Manufacturing

The collaboration will focus on developing manufacturing solutions for biosimilars.

Upstream Processing

Roquette Showcases Biopharma Innovations at CPhI Worldwide 2018

The provider of plant-based ingredients will present recently launched multi-compendial materials for upstream and downstream biopharmaceutical applications.

MilliporeSigma Adds CEX Resin and Amino Acids

New products were developed as next-generation process intensification technologies, MilliporeSigma reports.

Elements in Raw Materials May Impact Product Quality

Trace elements in raw materials may impact the quality and safety of the finished biologic product, according to industry experts.

Downstream Processing

Roquette Showcases Biopharma Innovations at CPhI Worldwide 2018

The provider of plant-based ingredients will present recently launched multi-compendial materials for upstream and downstream biopharmaceutical applications.

MilliporeSigma Adds CEX Resin and Amino Acids

New products were developed as next-generation process intensification technologies, MilliporeSigma reports.

Chromatography Resin Designed to Boost Process-Scale Productivity

Bio-Rad introduces CHT Ceramic Hydroxyapatite XT media and Nuvia HP-Q resin resin for process protein purification.

Standards/Regulations

USP Proposes a New Chapter for Rapid Sterility Testing

The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.

Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals

This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.

PDA’s New Technical Report Highlights Data Integrity Management System for Pharma Labs

PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.

Sponsored Videos

Sponsored eBooks

QbD and PAT in Biopharmaceutical Development
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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

FDA Expands NDMA Investigation to All ARB Class Drugs

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

Be a Part of the Solution

Sharing of bioprocessing know-how can help resolve pressing industry problems.

Characterizing Critical Quality Attributes in Biopharmaceutical Drug Development

Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.

Formulation

Thermo Fisher Scientific to Acquire Advanced Bioprocessing Business from BD

Becton Dickinson’s (BD) Advanced Bioprocessing business will be integrated into Thermo Fisher's Life Sciences Solutions segment.

QbD in the Development of ADCs with PBD Dimer Warheads

The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.

The Search for Next-Gen Expression Systems

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

Single-Use Systems

Pall and Aetos Biologics Partner on Biosimilar Manufacturing

The collaboration will focus on developing manufacturing solutions for biosimilars.

3M Enhances Emphaze AEX Hybrid Purifier

The new features on the purifier deliver additional sizes and sterilization/sanitization compatibility.

AGC Biologics Expands Capacity at Denmark Facility

The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.

mAb Development

Evaluating the Rewards vs. the Risks of Automation

Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.

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.

Vaccine Development

Study Finds Candidate for Universal Flu Vaccine Protects Against Multiple Strains

Research from the Perelman School of Medicine at the University of Pennsylvania suggests that a universal flu vaccine that protects people against most influenza strains is one step closer to reality.

CEPI, IDT Partner to Develop MERS Vaccine

The Coalition for Epidemic Preparedness Innovations (CEPI) and vaccine manufacturer IDT Biologika will collaborate to develop and manufacture a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).

Experts Reveal Ebola Vaccine Status and Potential

Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.

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