3 min read
As supply chain complexities grow, risks can arise at every phase of the product lifecycle. 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
Preclinical to preparation for clinical trials involves product formulation and process development during which the readiness for clinical trial must be demonstrated. 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 supplier cannot meet this additional product need, a setback like this could put the program on hold, further illustrating the need for a secondary supplier.
One common risk across all phases is the scrutiny of regulatory authorities on manufacturing processes, as well as patient adverse reaction data that might unexpectedly surface within clinical trials.
Concept to Clinic Solutions
Phase Two: Commercial Level Control
Commercial Level Control, scalability and stability, supports products that are approved or about to be approved. Using the Protect Your Brand backup strategy provides assurance 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 launch, the considerations shift to commercial risks related to unknown market demand, prevention of disruption of intermediate and active pharmaceutical ingredient (API) supply to maintain the necessary levels of production, and other factors of this nature. With no strings attached, the Protect Your Brand solution is a highly effective option to minimize these risks.
Commercial Solutions
Phase Three: Post-Commercial / Secondary Supply
This final lifecycle phase centers on product stability within the marketplace. Alcami provides continuity of supply and a flexible production option, safeguarding your brand from changes in market demand. For example, the demand for your branded product could decrease 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.
Alcami offers the right level of protection at all phases of the product's lifecycle. 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.
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