Top News

Novartis to Acquire Endocyte in Deal Worth $2.1 Billion

Oct 18, 2018

Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.

Amgen Launches Adalimumab Biosimilar in Europe

Oct 17, 2018

Amgen’s biosimilar to AbbVie’s Humira (adalimumab) is the first inflammation biosimilar from Amgen's portfolio to launch in Europe.

Sandoz Humira Biosimilar Patent Dispute Resolved

Oct 12, 2018

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

BioPharm eBooks

Biopharma Laboratory Best Practices 2018 eBook
This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products. 

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Biopharma News

Amgen And Provention Bio to Develop Celiac Disease Treatment

Nov 16, 2018

The companies will develop AMG 714, a novel anti-IL-15 monoclonal antibody, for the treatment of gluten-free diet non-responsive celiac disease in a collaboration worth $170 million.

AbbVie Signs Patent License with Momenta for Humira Biosimilar

Nov 08, 2018

AbbVie will grant Momenta license to launch a biosimilar to AbbVie’s Humira.

Sandoz Decides Against Pursuing Biosimilar Rituximab

Nov 08, 2018

The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.

Industry News

Manufacturing Challenges Limit Gene Therapy Development

Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.

EMA Recommends Four Medicines for Approval

The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.

EMA Publishes Guidance on Pediatric Drug Safety

The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.

Supplier News

GE Healthcare Manufactures Single-Use Consumables in China

GE Healthcare will collaborate with Wego Pharmaceutical in China for local production and supply of GE Healthcare’s Fortem single-use consumables.

Survey Predicts Drug Product Formulation Recognition and Increasing Budgets

Formulation issues cause significant drug project delays and project failures, according to a 2018 survey conducted by Informa Pharma Intelligence, Rentschler Biopharma, and LEUKOCARE.

Thermo Fisher Opens Newly Expanded Facility in Maryland

The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.

Upstream Processing

Media Requirements for Different Cell Sources

This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.

Innovation and Industry Strength Recognized at CPhI

Survey results and record attendance may show positive signs for established and emerging biopharma regions.

New Equipment Advances Biopharmaceutical Operations

Recent equipment and updated product options offer improvement to a range of biopharmaceutical manufacturing tasks.

Downstream Processing

Fujifilm, CPI Collaborate on New Technologies for MAb Downstream Processing

Fujifilm Diosynth Biotechnologies and the Centre for Process Innovation (CPI) are collaborating to complete the technology transfer of the expression and purification of model monoclonal antibodies (mAbs) as part of AMECRYS, a research project funded by the European Commission.

Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies)

The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.

Innovation and Industry Strength Recognized at CPhI

Survey results and record attendance may show positive signs for established and emerging biopharma regions.

Standards/Regulations

Impact of ATMP Manufacturing on Process Equipment and Facility Design

Advanced therapy medicinal products pose unique manufacturing challenges that will require appropriate and thoughtful facility design and equipment.

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.

Sponsored Videos

Sponsored eBooks

QbD and PAT in Biopharmaceutical Development
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Cell and Gene Therapies

Single-use and IIoT Solutions Expected to Reduce Costs and Enhance Production Efficiency

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

Can Gene Therapy Deliver on its Promise?

Improving the manufacturing of gene therapy vectors will be crucial to making advanced treatments accessible to more patients who need them, agreed panelists at the 2018 Galien Forum.

Be The Match BioTherapies Launches Program for Faster Cell Facility Onboarding

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

Analytics

Characterizing Protein-Nucleic Acid Conjugates with Light Scattering

This article presents two case studies regarding the characterization of protein-DNA complexes using two complementary multi-angle light scattering (MALS) techniques, namely size-exclusion chromatography (SEC–MALS) to determine absolute molar mass of each component, and composition-gradient MALS (CG–MALS) to quantify stoichiometry and affinity at binding sites in solution.

Combatting Counterfeit Biopharmaceuticals Using Hydrophilic Interaction Chromatography

The Column spoke to Steven Janvier, a PhD student at Sciensano and Ghent University (Belgium), and Celine Vanhee, a scientist at Sciensano, about their work to develop a hydrophilic interaction chromatography (HILIC) methodology capable of detecting counterfeit polar peptide drugs available on the black market.

Advanced Flow Cytometry System Breaks the Cost Barrier

Cytek Biosciences’ Northern Lights series of advanced flow cytometry systems brings reagent and application flexibility to more labs while enhancing performance.

Formulation

Survey Predicts Drug Product Formulation Recognition and Increasing Budgets

Formulation issues cause significant drug project delays and project failures, according to a 2018 survey conducted by Informa Pharma Intelligence, Rentschler Biopharma, and LEUKOCARE.

Innovations in Prefilled Syringes for Biologic Drugs

As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.

Whitepaper: Optimizing Excipient Properties for ODT Formulation

Orally disintegrating tablets (ODTs), also known as orodispersible tablets, are unique dosage forms formulated to improve their in vivo disintegration and dissolution rates. It is a big challenge to ODT producers to achieve a minimum disintegration time while keeping formulation simple and robust. The required advances in pharmaceutical manufacturing occurred when excipient suppliers developed multi-functional types for direct compression. Roquette’s PEARLITOL® Flash, a combination of mannitol and starch, is a ready-to-use excipient for orodispersible tablets. This article describes its application to formulation and how this delivers advantages like robustness and rapid disintegration time. PEARLITOL® Flash means problem-free ODT formulation.

Single-Use Systems

Lonza Releases First SUB Batch for TRACON Pharmaceuticals

The company has rolled out the first batch of TRACON Pharmaceutical’s lead product candidate from its Singapore-based single-use bioreactor.

Validating Virus Clearance in a Single-Use System Part 1: Film Adsorption and Virus Inactivation Studies

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.

A Plastic Pipeline for Commercial Bioprocessing?

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

mAb Development

Lonza Releases First SUB Batch for TRACON Pharmaceuticals

The company has rolled out the first batch of TRACON Pharmaceutical’s lead product candidate from its Singapore-based single-use bioreactor.

Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies)

The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.

Media Requirements for Different Cell Sources

This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.

Vaccine Development

MilliporeSigma Offers Insect Platform for Viral Vaccines and Gene Therapy Development

The company will collaborate with GlycoBac to offer an insect cell line for the development of viral vaccines and gene therapies.

Scientists Develop New Vaccine for Lassa Fever and Rabies

A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.

New Analytical Instrument Could Change Vaccine Development Through Faster Viral Detection

Research by Thermo Fisher Scientific and LumaCyte suggests that LumaCyte's Radiance instrument offers the ability to rapidly analyze viral vaccines to speed development and production and ensure their effectiveness.

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