CDMOs adopt flexible processes for manufacturing investigational drug products.

Speeding Up the Clinical Trial Process

Outsourcing companies fill the gap in drug development and manufacturing.

A Dose of Support During a Pandemic

Liquid and lyophilized forms and preparing for the large capacity present challenges.

Fill/Finish Challenges for COVID-19 Vaccines

Topic

Shannon Parisotto, MBA, is the corporate senior vice president of Charles River Laboratories.

Articles

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.  

Toxicology: Ensuring Drugs are Safe for People

The acquisition strategically expands SPT Labtech’s offering in sample management for life sciences.

SPT Labtech Strengthens Automation Services with BioMicroLab Acquisition

The second phase of the Myford facility expansion in California will add upstream and downstream processing suites.

Avid Bioservices Expands Biologics Manufacturing Capacity 

The companies have expanded their existing partnership to include 40 Million Doses of COVID-19 vaccine for South Korea.

Novavax Expands COVID-19 Collaboration and License Agreement with SK Bioscience 

The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

Quotient Sciences Acquires CDMO Arcinova

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

Avid Bioservices Enters Manufacturing Agreement with Humanigen for Lenzilumab

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

PathoQuest Joins CAACB Consortium as Viral Safety Expert

Feliza Mirasol is the science editor for 

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

Meeting Fill/Finish Challenges for COVID-19 Vaccines

Nexelis’ recent acquisition of GSK’s Marburg, Germany-based vaccines clinical bioanalytical laboratory expands its bioanalytical capabilities.

Nexelis Expands Bioanalytical Services with Bioanalytical Lab Acquisition

The £500,000 (US$686,294)-investment in mass spectrometry support will accelerate biologics development and approval.

Almac Invests in Expanding Global Biologics Testing Solutions

Natalie Balanvosky is just-in-time manufacturing solutions manager, Almac Clinical Services.

Bryan Thompson is production manager, Almac Clinical Services.

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

Demystifying Complex Clinical Trial Kit Preparation

A strategic separation is designed to enhance the value and growth of Paraxel’s contract research services and Calyx’s imaging businesses.

Parexel Informatics and Imaging Business Relaunches as Calyx

Jared Auclair is associate dean, Professional Programs and Graduate Affairs, and director, Biopharmaceutical Analysis Training Lab, Northeastern University.

Lori Stansberry is marketing manager, Pharma & BioPharma, Thermo Fisher Scientific.

Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.

Is Collaboration the Key to Accelerating Biotherapeutic Development?

After a hectic 2020, biopharma looks to deliver on COVID-19 vaccines and move other promising therapies forward.

Biopharma Gets Back to “New Normal” Business

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Outsourcing increases as the industry balances development and manufacturing of both COVID-19 treatments and non-pandemic-related medicines.

Supporting the Industry During a Pandemic

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing. 

Evonik Supplies Key LNP Technology for Gene-Based Drugs

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

Thermo Fisher Scientific Expands Sterile Drug Product Development and Commercial Manufacturing

Cytiva is adding process development, media and assay development, and contract development services at its facilities in Korea, Japan, Sweden, and the UK.

Cytiva Expands Cell and Gene Therapy Fast Trak Services

Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.

CDMOs strive for flexible, adaptable processes and fast tech transfer for manufacturing investigational drug products, including COVID-19 treatments and vaccines

Speeding Development and Manufacturing of Materials for Clinical Trials 

The new super plant, being built in Incheon, South Korea, will have a total biopharmaceutical manufacturing capacity of 256,000 L.