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Minimize Supply Disruption at Any Life Cycle Phase

As supply chain complexities grow, risks can arise at every phase of the product life cycle. From quality issues and drug shortages to new serialization regulations and natural disasters, today’s risks are significant and supply disruptions can be catastrophic. Alcami has been thinking extensively about what we can do to help solve this challenge.  As a result, we have created, Protect Your Brand™, a unique offering designed to support pharma and biotech companies pursuing a dual source strategy.

Under this program, Alcami will support tech transfer and validation of products in advance of potential manufacturing needs without any long-term commitment or minimum annual volume. We have developed a process to systematically analyze and identify supply risks and to create a backup plan accordingly. We use our proprietary State of Alcami Readiness scoring system to assess and assign a risk level to the supply chain in question.

Alcami's Protect Your Brand offers three distinct supply solutions to prevent disruptions from occurring during the earliest stages of development all the way through to post-commercial production. The three drug product phases for which Alcami has crafted solutions are: concept to clinic, commercial and post commercial.

Phase One: Concept to Clinic
The first pillar, Concept to Clinic, is within the preclinical to preparation for clinical trials phase in which product formulation and process must demonstrate the readiness for clinical trial. Risks at this phase are assessed for process, analytical design, drug safety and drug efficacy. You will want to initiate a backup supply option to minimize these risks.

For instance, Protect Your Brand minimizes supply disruption when you have a short-term clinical supply need and require a contract development and manufacturing organization (CDMO) to step in quickly with a solution and no strings attached. Another situation when a backup CDMO might be needed is when a product is within clinical trials and data shows that additional studies are required, creating an unexpected demand for additional sample materials and product. If the primary CDMO cannot meet this additional product need, a setback like this could put the program on hold, which further illustrates the need for a secondary supplier.

One common risk across the board is the regulatory authorities’ scrutiny on manufacturing processes, as well as patient adverse reaction data that might unexpectedly surface within clinical trials. 

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  • Raw material vendor qualification
  • Methods transfer report
  • Investigational new drug (IND) update support
  • Product gap assessment

Phase Two: Commercial Level Control
Alcami's second pillar is Commercial Level Control, through scalability and stability. This is when products are approved or about to be approved. Using the Protect Your Brand backup strategy is extremely valuable for younger companies lacking late-phase development and commercialization experience, in cases where there is a patient population in urgent need, or if delays will jeopardize funding.

Once your product is approved for market, the considerations shift to commercial risks related to unknown market demand, avoiding disruption of intermediate and active pharmaceutical ingredient (API) supply to maintain the necessary levels of production and other factors of this nature.  But again, with no strings attached, the Protect Your Brand solution is a highly effective option to minimize these risks.  

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  • Raw material vendor qualification
  • Methods transfer report
  • Registration batches for filing
  • Regulatory filing support
  • Product gap assessment

Phase Three: Post-Commercial/Secondary Supply
This final life cycle phase centers on product stability within the marketplace. Alcami provides continuity of supply and, if needed, a flexible production option. This flexibility might be about safeguarding your brand from changes in market demand. For example, perhaps the demand for your branded product has dropped due to patent expiry and generic completion. Protect Your Brand provides a viable production option when demand is down and your previous manufacturing construct was designed for large volume production.  With Alcami's backup policy, you receive only the volume you need.

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  • Raw material vendor qualification
  • Methods transfer report
  • Validation batches for filing
  • Regulatory filing support
  • Line extension support
  • Complete offerings from start to finish

Alcami offers the right level of protection at all phases of the product's life cycle. We provide broad in-house technical and regulatory expertise, along with innovative solutions for timelines and technical challenges. We have an excellent track record of regulatory compliance across numerous agencies with recent audits of our sites in 2016 and 2017, and a successful CDMO approval for all filings to date.

Alcami is a full service integrated CDMO that works on over 200 molecules annually, with a company size that allows for flexibility in response to your needs. Alcami is ready to protect your brand in a way that fits your unique needs through our State of Alcami Readiness system. 

Learn more:

 

Protect Your Brand On-Demand Webinar

Download Protect Your Brand Brochure

Topics: Thought Leadership Supply Chain