Optimizing the use of partners for clinical trials depends on selecting the right contractor.

Selecting and Optimizing the Right Manufacturing Partner

Recent outsourcing trends include early development services, biosimilar production, and RNA technology.

Outsourcing's Race Toward Novelty

Strategizing drug development in the preclinical phase has merit.

Preclinical Strategies Benefit Biopharma Development

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Articles

Tjoapack has doubled its packaging capacity with the completion of its Netherlands facility expansion.

Tjoapack Announces Completion of Netherlands Packaging Facility

ten23 health is expanding its sterile drug product manufacturing site at Visp, Switzerland to enlarge cold storage and visual inspections capacity and add clean rooms. 

ten23 health Expands its Sterile Drug Product Manufacturing Site at Visp, Switzerland

Joy Aho is the senior project manager for Be The Match BioTherapies.

Taking key considerations into account along the cell therapy supply chain can set cell therapy developers up for success.

Reducing Risk: Establishing Consistency and Scalability of Cell Therapy Starting Material

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

The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

Scaling Up Capacity for Cell Therapies

Jennifer Markarian is manufacturing editor of BioPharm International.

BioPharm International spoke with Colleen Floreck, vice president, Global Marketing and Strategy, Catalent Cell and Gene Therapy about the specific requirements and challenges for expanding production of viral vectors. 

Expanding Viral Vector Manufacturing

Under the two-year task order, ATCC will continue to support the DCEG MEAS program in receiving, processing, storing, analyzing, and distributing clinical specimens from different cancer types.

NCI Awards ATCC Task Order to Provide Cancer Epidemiology Services to Research Community

William Bakewell, PhD, is research fellow, GMP Lab, at PPD Clinical Research Services, Thermo Fisher Scientific.

Feliza Mirasol is the science editor for 

Capacity concerns and regulatory compliance considerations will drive the decision about outsourcing the manufacture of clinical trial materials.

Insights into Outsourced vs. In-house Clinical Trial Services

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

The Importance of Batch Record Reviews During Audits

Moderna and Thermo Fisher Scientific have formed a collaboration to leverage dedicated commercial fill/finish manufacturing capacity in the US for mRNA vaccines and therapies.