Outsourcing

Scaling Up Fast

Best practices for scaling up manufacturing under a short deadline.

Manufacturing Materials for Clinical Trials. Image: JHDT Productions - stock.adobe.com

Accelerating Clinical Trial Materials

Flexible, adaptable processes speed the manufacture of investigational drug products.

Selecting the Right-Fit Partner for Biotherapeutic Development. Image: A. Hartung/STOCK.ADOBE.COM

Making the Best Match

Communication and transparency help foster strong manufacturing partnerships.

Collaboration Takes Cell and Gene Therapies Closer to Their Full Potential. Image: warut - Stock.adobe.com

Collaboration toward Commercialization

Innovators, contractors, and technology providers advance cell and gene therapies.

Avid Bioservices Expands Biologics Manufacturing Capacity

February 22, 2021

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

Wavelength Pharmaceuticals Acquires Vanamali Organics

February 18, 2021

The deal expands Wavelength’s drug substance manufacturing footprint and its API CDMO business.

Cascade Chemistry Expands API Manufacturing Capacity

February 18, 2021

Cascade began production on new facilities to manufacture APIs for clinical and commercial GMP production.

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

February 17, 2021

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

Quotient Sciences Acquires CDMO Arcinova

February 17, 2021

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

Avid Bioservices Enters Manufacturing Agreement with Humanigen for Lenzilumab

February 04, 2021

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

PathoQuest Joins CAACB Consortium as Viral Safety Expert

February 04, 2021

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.

Toxicology: Ensuring Drugs are Safe for People

February 02, 2021

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

Protein Characterization Can Support Regulatory Submission

February 02, 2021

Having a clear and detailed understanding of exactly what a biomolecule entails is essential for therapeutics development.

Delivering a Wealth of Expertise

February 02, 2021

Outsourcing partners can provide a multitude of advantages in the development of drug delivery solutions, including those designed for targeted patient populations.

Equipment Suppliers and CDMOs Advance Process Development

February 02, 2021

Collaboration between equipment suppliers and users is leading to innovation and optimization in biopharmaceutical manufacturing.

Best Practices for Designing and Building a Pharmaceutical Manufacturing Facility

February 02, 2021

For drug sponsors that are considering building their own manufacturing facilities, an expert project team is crucial.

Meeting Fill/Finish Challenges for COVID-19 Vaccines

February 02, 2021

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

Nexelis Expands Bioanalytical Services with Bioanalytical Lab Acquisition

February 01, 2021

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

Almac Invests in Expanding Global Biologics Testing Solutions

February 01, 2021

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

Demystifying Complex Clinical Trial Kit Preparation

February 01, 2021

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

Contract Service Tapped to Produce COVID-19 Vaccines

February 01, 2021

Contract development and manufacturing organizations provide vital services to rush COVID-19 vaccines to patients.

Is Collaboration the Key to Accelerating Biotherapeutic Development?

January 05, 2021

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

Bringing Bio/Pharma’s “New Normal” Into Focus

January 03, 2021

Biopharma looks to deliver on COVID-19 vaccines and other promising therapies.

Compensation Does Not Necessarily Align With Job Satisfaction

January 03, 2021

Essential bio/pharma employees show hard work and dedication can pay off for patients.