Newsletter | October 14, 2020

10.14.20 -- Wanted: Multi-Experienced Employees For Outsourcing

From The Editor
Featured Editorial
Industry Insights
Transportation Solutions For Cell And Gene Therapy Supply Chains

Developing a strong supply chain for your cell and gene therapy can make your company a more attractive target for acquisition as well as a more competitive player in the commercial environment.

Driving Efficiency And Reducing Waste, New Approaches To Sustainable Chemistry Are Greener By Design

When it was conceived by the Environmental Protection Agency (EPA) more than 30 years ago, “Green Chemistry” was intended to prompt solutions to real-world environmental problems resulting from industrial processes, emissions, and waste. These drivers remain as relevant now as they were then.

Show, Don’t Tell: How CDMO Quality Systems Affect Your Product

Kindeva’s quality philosophy embraces customer audits and regulator inspections as opportunities for continuous improvement in both our operations and the products we manufacture.

Business Continuity Program Helps Maintain Operations In The Face Of Crisis

Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations during a crisis situation.

Using Quality By Design For Process Development And Scale-Up Of A Novel ALS Drug Product

Thermo Fisher’s stepwise approach to quality by design (QbD), an approach that drives consistent quality into manufacturing, became integral to the success of Amylyx's AMX-0035 campaign. 

Aseptic Filling Operations To Keep In-House Or Outsource

With challenges such as facility infrastructure, auxiliary equipment, and facility cleanroom requirements it is imperative that startup biopharmaceutical companies invest in moving forward instead of backward, primarily in relation to automated aseptic filling. Pouring millions into the infrastructure and quality systems necessary to move away from manual filling is unrealistic and takes away from their valuable strengths in drug development. Partnering with CDMOs that have established procedures, training, and facilities can save time and money.

Simplifying The Supply Chain With Large-Volume Western CDMO Partners

When considering primary and secondary sourcing options it is important to balance price and security of supply. Partnering with an integrated, Western CDMO with large-volume production capabilities for registered starting materials (RSMs), advanced intermediates, and active pharmaceutical ingredients (APIs) can provide countless advantages, including reliability and superior communication, at a competitive cost.

Understanding Quality Agreements Between You And Your Service Provider

An effective quality agreement communicates the responsibilities of each party in a clear, concise manner, allowing the reader to quickly and accurately determine to whom a specific responsibility is assigned. 

Tech Transfer And Scale-Up For Custom APIs Driven By A Collaborative Culture

Technical expertise and access to state-of-the-art equipment and facilities are necessary but insufficient for successful completion of small molecule API technology transfer projects. CDMOs must have a collaborative culture that encourages open and transparent communication among internal team members, client representatives, and other external partners.

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A New Decade Of Outsourcing: What Can We Expect

Will the "Twenty-Twenties" be as exciting as they sound for our industry? For certain, nobody foresaw that a coronavirus outbreak would put outsourcing in such a public light. Outsourced Pharma hosted a live, virtual discussion in June 2020 focusing on four key areas: continuous manufacturing, cell and gene therapy influences, new sponsor-CDMO service models, and "Supply Chain 4.0."