Taking Full Advantage of Service Providers

Husni,Daria;

Taking Full Advantage of Service Providers

April 1, 2024

By Daria G. Husni

Feature

Article

BioPharm InternationalBioPharm International, April 2024

Volume 37

Issue 4

Pages: 32-33

There are considerations companies may want to consider before seeking out a service provider.

In Modern Laboratory Senior Female Scientist Has Discussion with Young Male Laboratory Assistant. He Shows Her Data Charts on a Clipboard, She Analyzes it and Enters It into Her Computer. | Image Credit: © Gorodenkoff - stock.adobe.com

In outsourcing, a partner well versed in clinical trial materials (CTMs) can be a valuable asset. But there are considerations companies may want to take before seeking out a service provider. BioPharm International® spoke to Jason King, director BD at Ascend, on the various aspects of working with a partner for CTM, from the advantages of CTM to region-specific barriers potential partners could face.

Benefits of outsourcing CTMs

BioPharm: Could you please run through the key benefits of working with an outsourcing partner for CTM?

King (Ascend): Working with an outsourcing partner allows a team to immediately build forward with the know-how of expert teams instead of having to build capacity and hire more internal capability in a highly competitive sector. Outsourcing CTM also allows product development companies to focus on developing new product candidates while moving the existing ones forward via the outsourcing partner. This helps to optimize what every member of the internal and external team is good at, while saving time and money in these earlier stages. And if/when products move forward with an outsourcing partner, they should be going to into clinically validated and therefore de-risked manufacturing platform, saving more time and money over the life of the process.

BioPharm: Can there be separation in what can be outsourced, as in the manufacture of CTM, the packaging, analytical services, testing, and so forth? Can such a separation be advantageous, or do you think it is better to request a more full-service package from a contract development and manufacturing organization (CDMO)/contract manufacturing organization (CMO)?

King (Ascend): Yes, and this happens quite often since many clinical manufacturers do not have on-site capacity for all the analytical and testing services required. Though it is most efficient to select a provider that can do it all, it is still beneficial to have samples tested by a second provider for risk mitigation purposes. Separation will even be necessary in instances where CTMs are manufactured and released outside the EU [European Union] as drug product testing or for CTMs used in EU clinical trials that require EU release testing.

The modality will matter here, because we see that fill/finish providers for ATMPs [advanced therapy medicinal products] are still comparably rare, and the analytical/testing side is less mature. So, in many cases, a customer may have no choice but to have multiple providers as the advanced therapies space continues to evolve.

BioPharm: Do you think there are advantages or disadvantages to employing more than one services provider for CTMs?

King (Ascend): The modality and the global demand for a product will be part of this consideration.

In the aftermath of the COVID pandemic, it became clear that multiple providers of clinical manufacturing can be valuable in reducing the supply risks. For a modality like cell therapy, this is particularly true when the product being manufactured is complex and needs to be made close to the site of the clinical administration.

When you are working with global patient populations and manufacturing networks, the logistics of manufacturing and testing can become more complicated and require numerous sites. For example, when performing stability studies, a sample may need to be shipped to another facility.

Regulatory requirements

BioPharm: Are there specific regulatory requirements that companies should be aware of when partnering with a service provider for CTMs? For example, regional-specific variances that could prove problematic later down the line?

King (Ascend): There are different requirements for GMP [good manufacturing practice] manufacturing facilities in the [United States] and EU that need to be considered when a product is intended to be used in multinational clinical trials. There can be differences in the things such as the duration that retain samples should be held for, or the minimum reference sample size to comply with the number of times the complete analytical controls can be repeated. There can also be differences in interpretation of the regulations around facilities, particularly the revised EU Annex 1. The FDA has no obligation to comply with the Annex 1 requirements; however, it states publicly that it is aligned with the principles of Annex 1.

Selecting a service provider

BioPharm: Could you provide some useful tips/best practices for companies to follow who may be seeking out a service provider (or more than one) for their CTM needs?

King (Ascend): Sourcing a cell and gene therapy CDMO can be trickier due to the maturity of the market. The customer must consider the specific know-how/IP ownership clarification and find a manufacturer strongly focused on product quality. The CDMO should have a flexible tech platform, ideally including the analytics needed. Providers with good analytics development teams are even more critical when bespoke assays are needed for specific gene expression assays or gene therapy potency assays.

While it matters, speed should not be the main focus in these relationships. It has to be quality and longevity or what a recent article called the ‘3 Cs’: capacity, comparability, and capability (1). Does the provider have the space (capacity) to support your product with the ability to complete tech transfers and perform comparability exercises where needed? And do they have platform modularity and adaptability and human expertise (capability) to meet needs and ensure risk is mitigated for the life of the product?