ELEVECTA® - The Next Level in Gene Therapy AAV Production

August 10, 2020

Introduction of ELEVECTA®, CEVEC’s fully scalable and stable production platform for AAV gene therapy viral vector manufacturing.

Pfizer and BioNTech to Supply Japan and Canada with mRNA-Based COVID-19 Vaccine Candidate

August 07, 2020

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

Novartis Gets EMA Approval for Two European Commercial CAR-T Manufacturing Sites

August 07, 2020

The European Medicines Agency recently approved two European Novartis sites in France and Switzerland for the commercial manufacturing of chimeric antigen receptor T-cell cell therapies.

SBIR Awards $1.4-Million Grant to Accelerate Antibody Manufacturing Technology

August 07, 2020

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

J&J in $1-Billion Agreement with US Government for 100 Million Doses of Investigational COVID-19 Vaccine

August 07, 2020

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

Sanofi and GSK to Supply COVID-19 Vaccine to US Government and European Union

August 07, 2020

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

Lonza Expands its Microbial Manufacturing Facility in Switzerland

August 06, 2020

The expansion will involve using the facilities’ existing central utilities and labs to supplement its small-scale and large-scale assets.

Catalent to Expand its Argentinian Site

August 06, 2020

The expanded facility will feature two new 40-L and 300-L manufacturing vessels, a capsule filling line, and six drying tunnels that will add more than 10 million doses per annum to the site.

FDA Approves First Cell-Based Gene Therapy for MCL

August 06, 2020

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

Drug Safety Summit Discusses Impact of COVID-19 on Pharma Supply Chain

August 05, 2020

Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.

PPD and Pfizer Enter into Three-Year Agreement

August 04, 2020

PPD announced it will provide drug development services to advance Pfizer’s portfolio.

Debate Accelerates Over Who Gets COVID Vaccine First

August 03, 2020

As biopharma companies and research institutes advance the development of COVID-19 vaccines, policy makers and health officials are debating strategies for ensuring fair and equitable distribution of anticipated preventives.

Polyplus-transfection Launches Residual Test for Transfection Reagents

August 03, 2020

The company has launched a residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture.

MilliporeSigma Invests $20 Million in New Switzerland Laboratory

August 03, 2020

The investment will allow for the expansion of analytical R&D efforts and will support the company’s reference materials business.

MOBILIon’s SLIM Technology Enhances R&D Analytics

August 03, 2020

The company’s SLIM technology has been a part of the company’s accelerated growth by offering enhanced R&D analytics.

Chromatographic Science Clarifies Separation Challenges

August 02, 2020

New therapeutics modalities and the need for greater process efficiency are driving technology development.

The Impact of SARS-CoV-2 on Biomanufacturing Operations

August 02, 2020

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.

Formulating an ADC Development Solution

August 02, 2020

Many antibody-drug conjugate therapies are in the pipeline; only a handful have been approved. What are the bottlenecks?

Using Process Modeling to Troubleshoot a Bioprocess

August 02, 2020

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

Points to Consider for Continuous Downstream Bioprocessing

August 01, 2020

It is critical to evaluate specific considerations, from design to application, for the benefit of downstream bioprocessing and manufacturing.

CDMOs Build Fill/Finish Capacity for COVID-19 Vaccines

August 01, 2020

Filling and packaging of primary containers is a crucial piece of COVID-19 vaccine production.

Aseptic Processing Practices: Reviewing Three Decades of Change

August 01, 2020

Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.

Predicting Extractables and Leachables from Container Stoppers

August 01, 2020

Data from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.

Regulating Raw Materials Testing

August 01, 2020

Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.

Global Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs

August 01, 2020

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

It’s Time to Listen to Science

August 01, 2020

Time sure flies, except when you are waiting for something to happen.

Training During a Pandemic

August 01, 2020

When in-person training may not be feasible, there are still opportunities to ensure employees receive the required training, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

Rigenerand Develops 3D Bioreactor for Extracellular Vesicle Exosomes Production

July 31, 2020

The company has begun development of a 3D bioreactor for the cGMP production of extracellular vesicle exosomes.

Challenges in Bulk Drug Substance Management

July 31, 2020

Biopharma Insights—Thought Leadership from Marketers | Paid Program

Final liquid drug substance production and fill–finish activities rarely occur at the same site. Nearly all pharmaceutical and biotechnology companies outsource a portion of their fill–finish needs to contract manufacturing organizations (CMOs) to help them address unexpected demand, satisfy second source policies, or better match scale with need.

Vico Therapeutics Raises $31 Million in Series A Financing Round

July 30, 2020

Vico Therapeutics has raised $31 million (€27 million) in a Series A financing round, which the company will use to further advance its Antisense OligoNucleotides lead platform.