Outsourcing

The first part of the 2021 CPhI Annual Report has been published and predicts a strong outlook for CDMOs over the next few years.

ProductLife Group (PLG) and Juuka Advisory have teamed up to form a new consulting offering, ProductLife Consulting.

AGC Biologics is expanding manufacturing capacity at its Heidelberg, Germany, facility for plasmid DNA and messenger RNA.

Sterling Pharma Solutions has invested in a center of excellence for research into commercial applications of continuous flow chemistry at its site in Dudley, UK.

As interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases.

The functionality of a digital quality management system (QMS) provides visibility into critical supplier activity and helps ensure a high-quality product.

Vincent Colicchio, vice president, supply chain and external manufacturing at Dr. Reddy’s Laboratories, discusses how a lack of proper supplier oversight can impact the pharmaceutical industry and the drug supply chain.

Febles will oversee day-to-day aseptic manufacturing at Pharmaceutics International, Inc.

Quotient Sciences is investing £6.3 million ($8.68 million) into their drug substance manufacturing capabilities.

AGC Biologics has broken ground on a new multipurpose facility in Copenhagen, Denmark, that will increase capacity.

Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.

Curia plans to expand the site’s commercial capabilities with this move.

Biotage’s new facility in Cardiff, UK, will produce lipids using large-scale flash purification.

Dosage form priorities are shifting to focus on user-friendliness, leading to greater engagement with outsourcing partners earlier in development timelines.

Collaborative partnerships can foster success in formulation development projects.

Investments, biologics, and the impact of COVID-19 will continue to shape the bio/pharmaceutical outsourcing industry for the near term.

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

There are some key questions that should be asked by both the sponsor company and the outsourcing partner before undertaking a method development project.

The choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.

Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both approaches.

The CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.

Manufacturers seek more sustainable options for temperature-controlled packaging.

CDMO Idifarma has launched a new service aimed at delivering an accelerated pathway for complex drugs.

Purisys is now certified for ISO 17025 for testing and calibration laboratories and ISO 17034 for reference material producers

LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.