Top News

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Dec 05, 2017

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

EMA to Relocate to New HQ in Amsterdam in Wake of Brexit

Nov 21, 2017

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

FDA to Recognize Inspections from EU Drug Authorities

Oct 31, 2017

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

BioPharm eBooks

Vaccines Development and Manufacturing 2017 eBook
Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.      
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Biopharma News

FDA Approves Pfizer Biosimilar to J&J’s Remicade

Dec 14, 2017

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

Vertex and CRISPR Therapeutics Partner on Gene Therapy for Blood Disorders

Dec 13, 2017

The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.

Novo Nordisk Expands Insulin Manufacturing Facility in India

Dec 13, 2017

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.

Industry News

New Immunotherapy for Pediatric Brain Cancer Targets Mutated Protein

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.

FDA Releases Draft Guidance on Gluten in Drug Products

The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.

Contract Manufacturing Raises Regulatory Concerns

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

Supplier News

Abzena Secures ADC Manufacturing Contract with US Biotech Firm

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

EMA Approves mAb Production at Samsung BioLogics Facility

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.

SGS Adds GMP DNA Sequencing Capabilities at Glasgow Facility

SGS has introduced a Sanger sequencing service at its Glasgow, United Kingdom, laboratory to support genetic stability testing and perform identity testing on cell banks, plasmids, and viral seeds/vectors.

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.

Upstream Processing

Groninger and Martin Christ Partner at CPhI Worldwide 2017

Groninger will showcase its FlexPro 50 line for small batch production at CPhI Worldwide 2017, and present on up- and downstream processes with freeze-dryer developer and manufacturer Martin Christ.

Sartorius Stedim Cellca Builds Laboratory and Office Facility in Germany

Sartorius begins building a new, EUR 30-million (US$35.2 million) Cell Culture Technology Center in Ulm, Germany.

Molecular Cloning, Expression, and Purification of a Recombinant Fusion Protein (rNT-gp96-NT300)

This study is an attempt to produce a fusion protein by binding the fragment NT-gp96 in upstream of sequence of the N terminal fragment (NT300) of the NS5B gene in an expression vector.

Downstream Processing

Reducing Cross-Contamination Risks in Process Chromatography

Single-use systems provide replaceable fluid paths.

GE Healthcare Completes Acquisition of Bioprocessing Start-Up

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

Connector Integrity in Single-Use Biomanufacturing Systems

Connectors are a critical element in the process optimization of single-use bioprocessing systems.

Standards/Regulations

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Will Pharma Meet the Drug Tracking Deadline?

Manufacturers and trading partners struggle to meet drug tracking requirements

FDA’s Policy on Regenerative Medicine Therapies

Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.

Sponsored Videos

Sponsored eBooks

QbD and PAT in Biopharmaceutical Development
In this eBook, learn how the adoption of QbD and Process Analytical Technology (PAT) as well as Design of Experiments techniques help biopharmaceutical companies improve efficiency and accelerate time to market. 
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Analytics

SGS Adds GMP DNA Sequencing Capabilities at Glasgow Facility

SGS has introduced a Sanger sequencing service at its Glasgow, United Kingdom, laboratory to support genetic stability testing and perform identity testing on cell banks, plasmids, and viral seeds/vectors.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Single-Use Bioreactors Pose E&L Challenges

A roundtable Q&A with biopharma executives elucidates the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process.

Formulation

Survey Measures Biopharma Career Highs and Lows

Biopharma employees reveal employment objectives, opportunities, and frustrations.

Record Attendance at CPhI Worldwide Reflects Pharma’s Strength

Germany tops quality ranking in the inaugural CPhI Global Pharma Index.

ADC Targets Fail Because of Aggregation Problems

ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.

Single-Use Systems

Additional Size for Quaternary Diaphragm Pumps

The Quattroflow QF10k size pump from PSG, a Dover company, has been added to its line of quaternary, four-piston diaphragm pumps.

Single-Use Bioreactors Pose E&L Challenges

A roundtable Q&A with biopharma executives elucidates the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process.

Design Solution for Single-Use Technology Applications

SciLog Select Go Single-Use Assemblies from Parker Hannifin uses an assortment of validated parts and assemblies to build needed devices for biopharmaceutical manufacturing.

mAb Development

FDA Approves Pfizer Biosimilar to J&J’s Remicade

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

EMA Approves mAb Production at Samsung BioLogics Facility

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.

FDA Accepts Lilly’s Application for Migraine Biologic

FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.

Vaccine Development

New Immunotherapy for Pediatric Brain Cancer Targets Mutated Protein

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.

Accelerating Vaccine Development and Manufacturing

The use of approved platform technologies can reduce the time and cost required to generate new vaccines.

Making Vaccines Accessible

Despite the challenges and high cost of development, vaccine innovation is at an all-time high, as new approaches aim to improve global access.

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