Blog IDBSproduzione di terapie farmaceutiche in outsourcing

Blog IDBS | 5 aprile 2018

Contract manufacturing organizations: Choosing the right partner and driving better collaboration

Contract manufacturing organizations (CMOs), more commonly now referred to as contract development and manufacturing organizations (CDMOs), are companies that provide drug development and manufacturing services in the pharmaceutical industry on a contract basis.

These organizations prove useful to biopharma and pharma companies who do not have the resources and capabilities to develop and manufacture at scale in-house, or those looking to save on costs associated with building manufacturing plants and production teams. Outsourcing offers the ability to meet market demand faster and also opens the door to specific expertise as some CMOs are specialists in manufacturing specific products and formulations.

Selecting the right contract manufacturing organization to partner with is just the start of a relationship. Your choice of manufacturing partners can set you up to succeed with a lean team, underscoring the need to carefully weigh their experience in the modalities you develop and their willingness to collaborate on multiple dimensions.

What to look for in a contract manufacturing organization

Contract manufacturing organizations give pharmaceutical and biologics manufacturers one of the most important assets in today’s fast-paced world: time. By outsourcing manufacturing processes, pharmaceutical and biologic manufacturers can free up the internal resources required to prioritize internal capacities and enhance process efficiencies.

Outsourcing is critical for the manufacturing of pharmaceuticals and biologics. Choosing the right partner is integral to success and sustainability. In addition, choosing the right CMO in pharma can not only help save costs from economies of scale but also achieve results faster.

Key requirements for CMOs

Cutting costs isn’t (and shouldn’t be) the primary factor for pharmaceutical and biologics manufacturers in choosing the right organization for outsourcing. Technological capabilities, access to specialized technologies, quality and transparency of service, and the geographical location of the contract manufacturing organization are key differentiators.

Come gestire al meglio la relazione

Those doing the outsourcing must also keep in mind that no relationship is one-way, expectations should be realistic. When employing a contract manufacturing organization, both parties need to be aware of compliance liabilities attached to the products in question. Compliance of the contract manufacturing organization needs to be monitored by the contractor, while also assisting with the deployment of risk prevention action plans. Overall transparency, managing expectations, and a clear vision of strategy in the communication process remain vital ingredients for a blooming relationship.

What’s driving the contract manufacturing organization market’s growth?

  • Increasing demand for generic drugs
  • Growing prevalence of chronic diseases
  • Accelerating the development of personalized medicine
  • Increasing adoption of advanced manufacturing technologies
  • Escalating cost of in-house development and manufacturing

Take the last three points together and it represents one of the fastest-growing areas where contract manufacturing organizations are becoming crucial: cell and gene therapies.

Traditional time frames for bringing a novel treatment to market have been shattered with pharmaceutical and biologics treatment developers expected to deliver commercial products in just years instead of a decade or longer. More than ever before, sponsors and their contract manufacturing organizations have the greatest need and the greatest opportunity to collaborate and accelerate life-changing therapies to patients where the best collaboration is defined by seamless and efficient technology transfer.

Why tech transfer matters even more today

With increasingly complex large molecule and precision medicines being developed and commercialized at a record pace, efficient technology transfer (tech transfer) between pharmaceutical, biologics and contract manufacturing organizations is more important than ever. Key to success is addressing tech transfer comprehensively from R&D through clinical trials and manufacturing, which is where BioPharmaceutical lifecycle management (BPLM) is essential to delivering novel therapies and lifesaving drugs to the world. It encapsulates every stage of sviluppo del farmaco, including drug candidate identification, clinical trials establishing efficacy, manufacturing processes and supply chain activities for delivering these therapies to patients.

Each of these vertical pipeline activities typically lives in separate parts of an organization, with specialists, equipment and digital tools customized for those needs. Technology transfer is the process that bridges the gaps between these different parts for the transfer of information about development, manufacturing and quality assurance.

Even the most well-established pharmaceutical and biologics companies are challenged when it comes to implementing tech transfer successfully. While some modalities, such as monoclonal antibodies and small molecules, lend themselves to a platform approach, others such as CGT and mRNA therapies are relatively new to the industry and the complexity, variability and clinical turnaround time of these newer therapeutics place tremendous stress on an already brittle process.

Good digital strategies for CMO tech transfer

Modality expertise, location and a tight business relationship are fundamental when selecting the best-fit manufacturing facility and contract manufacturing organization. When selecting a contract manufacturing organization, pharmaceutical and biologics sponsors should also evaluate the CMO’s willingness to use digital data-sharing platforms. For example, a manufacturer supplying batch data in Excel files or on paper can hinder production and monitoring, leading to delays in batch release.

Digital data sharing also needs to be emphasized early in the tech transfer process, especially when forming new partnerships. The participation of a new partner in digital data sharing may require a culture shift in the entire supply chain, as the partner may need new tools and training, as well as proper contractual agreements to ensure continued compliance from both sides.

Data sharing can meet with resistance when sponsors assume that contract manufacturing organizations will give them access to their systems upon demand, or with delays when data is shared in “dead-end” data files such as PDFs. However, contract manufacturing organizations also have other clients and store data for multiple manufacturing lines in electronic lab notebooks (ELN) e i sistemi di gestione delle informazioni di laboratorio (LIMS). These databases hold experimental information and results for all products the CMO manufactures which often creates contractual limits on providing access to a sponsor.

Tools are commercially available today to support collaboration around the digital sharing of recipes, Certificate of Analysis (CoA) and manufacturing batch data. With the help of these tools, process information management systems (PIMS) can transform tech transfer from a static activity to dynamic, persistent and compliant knowledge sharing.

CMO tech transfer needs speed and quality

When it comes time to commercialize following regulatory approval, speed to market is critical. What sponsors and contract manufacturing organizations need is a tech transfer solution that spans all parts of the process, not just the final manufacturing stage. This need becomes even more essential in scale-up procedures for the mass production of novel therapies. There are also raw material providers to select, time requirements to consider, and analytical testing procedures to agree to, all of which require standard operating procedures to be put in place.

Pharmaceutical and biologics sponsors and their contract manufacturing organizations can move quickly to fully compliant Continued Process Verification (CPV) and Good Manufacturing Practice(GMP) manufacturing with less time, cost and risk using PIMS versus more complex methods involving paper, spreadsheets and disparate systems.

As COVID-19 mRNA vaccines taught us, breakthrough treatments can now accelerate from R&D to patients in less than two years, setting the bar for the pharmaceutical and biologic industry. This is creating both an opportunity to fast-track life-changing medicines as well as pressure testing the tech transfer process at its most vulnerable juncture where sponsors and contract manufacturing organizations must collaborate. Bringing well-timed tech transfer efficiency to match today’s drug and precision medicine manufacturing, BPLM and PIMS trasformazione digitale are paving the way for higher quality and faster delivery of therapies to patients.

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