Outsourcing

Can CDMOs apply lessons learned from the COVID-19 pandemic to improve sterile processing?

Preclinical studies specifically benefit from the “smart” drug development trend through deeper data access and analysis.

Ginkgo Bioworks has acquired StrideBio's AAV capsid discovery and engineering platform and has formed a partnership with WARF for development of next-gen cell therapies.

Anil Kane, executive director, Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific, discusses the growing role of CDMOs in the biopharma industry

Stephen Houldsworth, VP and Head of Platform Management & Marketing at CordenPharma, dives into ongoing trends in the outsourcing space.

In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.

The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.

The trends shaping the growth of the biologics outsourcing industry demand attention.

CMO growth is focused on analytical testing, toxicity testing, and fill/finish operations.

In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.

Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.

Agilent’s $725 million investment is designed to double its capacity to produce APIs.

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

In the all-too-common debate over building lab facilities versus outsourcing, the best strategy may be the middle ground: licensing.

Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.

In this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.

The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.

Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.

Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

Integrated project delivery can fast-track delivery targets by eliminating the waste involved in traditional approaches to project set-up and execution.

A thorough understanding of both regulatory requirements and study challenges can help develop and validate the appropriate methods for a bioanalytical study program.