Top News

EMA Recommends Approval of First Stem-Cell Therapy

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

Novo Nordisk to Partner with Xencor in the Development of Engineered mAbs

Xencor's technology focuses on the use of antibody and protein biotherapeutics to treat immune-related diseases.

Fujifilm Acquires Kalon Biotherapeutics

Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.

Biopharma News

Cell Therapy Manufacturing Center to be Built in UK

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

Roche Acquires Bispecific Antibody Developer Dutalys

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.

Merck Acquires Biotechnology Company, OncoEthix

Merck announced that it acquired OncoEthix, a biotechnology company specializing in oncology drug development, for up to $375 million.

Supplier News

Paragon Bioservices to Scale Up Protein Manufacturing

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

Grand River Aseptic Manufacturing Secures Two Contracts

Grand River Aseptic Manufacturing has announced that the company executed two commercial production contracts in one day.

SGS Lab in Italy Earns cGMP Accreditation

SGS Life Science Services has been awarded cGMP accreditation from AIFA for its analytical laboratory in Livorno, Italy.

Discovery Pipeline

Yale and Gilead Extend Sequencing Initiative

The Yale School of Medicine and Gilead will continue their research on cancer targets for a minimum of three additional years.

Novartis Reports Positive Results for Secukinumab in Ankylosing Spondylitis Trials

Secukinumab is the first IL-17A inhibitor to meet its primary endpoint in two Phase III trials for patients with ankylosing spondylitis.

FDA and NIH Win Award for IP Licensing of Meningitis Vaccine

Partnership is awarded for licensing of low-cost vaccine for the treatment of bacterial meningitis.

Peer-Review Research

Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein Aggregates

The use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.

Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical Biopharmaceuticals

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

Concentrating Feed—an Applicable Approach to Improve Antibody Production

Different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.

Upstream Processing

Cell Therapy Manufacturing Center to be Built in UK

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

Viral Clearance Challenges in Bioprocessing

Challenges remain for virus removal and validation.

Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical Biopharmaceuticals

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

Downstream Processing

Viral Clearance Challenges in Bioprocessing

Challenges remain for virus removal and validation.

Pall ForteBio Releases Bioprocessing Contamination Detection Kit

Pall ForteBio introduces a solution for quantifying residual host cell proteins in CHO cells.

Application of Quality by Design to Viral Safety

A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.

Single-Use Systems

Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Amgen Opens Single-Use Manufacturing Plant in Singapore

The $200-million project will expand Amgen's single-use/disposable manufacturing capabilities.

Secure Single-Use Systems

Experts discuss trends in single-use bioreactors, disposable chromatography, and best practices for reducing particulates in single-use systems.

Analytics

Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein Aggregates

The use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.

Improving PAT for Biologics

Implementing process analytical technology for bioprocessing presents unique challenges, but the recent emphasis on establishing a thorough understanding of the manufacturing process is a key enabler of PAT approaches.

Developing Representative Sampling Plans for Development, Problem Solving, and Validation

The ability to define a scientifically justified and statistically sound sampling procedure is a fundamental skill in modern systematic drug development.

eBook Series

Secure Single-Use Systems

Experts discuss trends in single-use bioreactors, disposable chromatography, and best practices for reducing particulates in single-use systems.

Outsourcing Strategies

Trends and best practices for the use of outsourcing serivces, pricing models, contract manufacturing, facility development and location activities, and clinical trial services.

eBook Series: Analytical and Bioanalytical Testing

Review new technologies and best practices in testing for viral contamination and biosimilars; method transfer practices; data management strategies; and protein purification processes.

Editor's Picks

The Biopharma Working Life

Industry professionals share the ups and downs of working in the biopharma industry.

Year in Review: Key Outsourcing Trends

Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.

Hype vs. Health

Ebola Virus Disease (EVD) is a severe, often fatal disease that is transmitted human-to-human through bodily fluids.

Standards/Regulations

Biosimilar Development Moves Forward at FDA

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

FDA Releases Guidance on Electronic Regulatory Submissions

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

GPhA Supports FDA Proposed Rule on E-labeling

A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.

Formulation

Dalton Receives Funding for Development of RSV and Parainfluenza Type 3 Vaccines

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.

EMA Works to Speed Up Ebola Treatment

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

Challenges in Biologic Drug and Vaccine Delivery

Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.

Videos

mAb Development

Roche Acquires Bispecific Antibody Developer Dutalys

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.

FDA Approves Amgen Drug for Acute Lymphoblastic Leukemia

Amgen's bispecific T-cell engager (BiTE) antibody constructs help the body fight malignant cancer cells.

First Remicade Biosimilar Hits India

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Vaccine Development

Manufacturing Issues Crucial to Combating Ebola

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

EMA Works to Speed Up Ebola Treatment

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

Challenges in Biologic Drug and Vaccine Delivery

Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.