Outsourcing

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.

Following the acquisition by Altaris Capital Partners, Johnson Matthey Health has rebranded as Veranova.

In this episode of the Drug Solutions Podcast, Meg Rivers, senior editor, discusses the importance of proper training for aseptic processing with Patrick Nieuwenhuizen, director senior consultant, PharmaLex.

Industry experts discuss the need for stricter environmental controls, whether to incorporate single-use technologies, and areas for improved automation.

When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.

The inaugural Connect in Pharma event will take place on 14 and 15 September in Geneva, Switzerland.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

Through the Thermo Fisher Scientific and LabShares Newton partnership, life science startups can accelerate early-stage discovery and development with shared lab spaces.

PerkinElmer has expanded its genomics testing services with the launch of its ultrarapid whole genome sequencing.

Eurofins partners with PAMM to strengthen laboratory services for the Dutch healthcare system.

Lonza and Israel Biotech Fund form a two-year agreement to support accelerated development and manufacture of biologics and small molecules.