Outsourcing

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.

Actylis new 30,000-ft² API manufacturing facility is located in Eugene, Ore.

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

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

Quotient Sciences’ facility expansion is designed to increase support for fully integrated drug development programs.

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.

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.

Growth in outsourcing has been the result of COVID-19 projects taking precedence, which has pushed some contract manufacturing to second-tier CDMOs.

In the coming year, pharmaceutical innovation will be fueled by key trends throughout the quality sector.

The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.

Although new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.

CBM’s plasmid manufacturing offering is designed to provide phase-appropriate plasmids on demand for companies working on cell and gene therapies.

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.

CMOs are hoping to grow outsourcing to significantly higher levels in many different areas, with a focus on analytical testing, toxicity testing, and fill/finish operations.

Overall industry growth conceals growing numbers of smaller, faster-paced, adaptable corporate structures.

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

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

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

Industry experts discuss best practices for certificates of analysis.

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.

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.

Aenova Group and Microcaps are partnering to enable new customized formulations for product development and life cycle management solutions.