Outsourcing

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.

How dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.

Sponsors should explore key considerations ahead of choosing a new outsourcing partner.

External expertise is beneficial in helping companies select the right tools at the right stages of development to ensure success.

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

By eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Pharmaceutical Technology editors interview aseptic and sterilization experts from Watson-Marlow Fluid Technology Solutions and Cherwell—diving into sterilization, aseptic processing, and the revised EU GMP Annex 1 guidance.

The latest CPHI report has been published, predicting that a significant shift in outsourcing strategies is being experienced globally.

Automation of pharmaceutical packaging saves costs and time, say contract packagers.

Technological advances are progressing pharmaceutical packaging to overcome the challenges of the future.

Kindeva’s acquisition of iPharma will increase the company’s inhalation formulation outsourcing capabilities.

Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.