Launch & Commerical Supplies

The Technology Transfer Challenge:
Managing the Gap between Clinical, Submission and Launch Supplies.

Many large pharma companies, and almost all small ones, use contract manufacturing organizations (CMO) to make their product supplies for them.

However, when your generic drug has passed its bioequivalence trial, can your CMO provide the commercial supplies you need or will you have to transfer to a new site ? Technology Transfer (Tech Transfer or sometimes just “TT”) adds time, cost and risk to your development program, delaying commercialization.

It’s the same with branded products: whether it’s an NCE or Value-Added Medicine, the time between your last clinical trial and product launch is critical for market entry. Transferring your manufacturing process, and its analytical methods, to a new CMO at this critical late stage can seriously delay launch. If your product has modified-release properties, Tech Transfer might even require another clinical trial to be performed.

Altus Drug Development is a unique Contract Development and Manufacturing Organization (CDMO) that avoids the risks of Tech Transfer, providing the cost-effective R&D materials you need for laboratory and clinical trials, then executing seamless transition to submission, launch and commercial supplies.

Altus Integrated Development Services

A product ready for launch means a product well designed, and well developed. Altus helps partners plan and execute faultless product development providing;

Novelty and Innovation: Altus will develop novel and innovative product designs addressing unmet medical needs and gaps in the market. Altus innovation, and encompassing patent umbrella, provide new intellectual property for your product concept.

The Quality Target Product Profile (QTPP) for your new product detailing the product attributes needed to differentiate your new drug, generate the label you want, and achieve the sales you need.

The Strategic Regulatory Plan for efficient, informed and cost-effective development and approval of your product in the markets you want.

The Product Development and Manufacturing Plan to ensure seamless process, method and manufacturing of your product from pre-formulation to preparation of launch supplies, identifying the integrated development and manufacturing plan you will need for timely and cost-effective commercial supply.

The Patenting Plan to provide your product with immediate and continued in-market protection.

API Procurement. Altus can also help secure the API you need to ensure quality-driven development.

Product Development Services – Altus Can

Altus Drug Development offers integrated value adding services over and above formulation development and testing.
  • Identify innovative differentiating formulation designs to deliver the value of your product.
  • Generate milestone-driven road maps for product development with clear go/no-go criteria to define and manage your goals.
  • Develop, qualify and validate the analytical methods needed throughout the development process
  • Produce the formulations you need for pre-clinical testing.
  • Produce the formulations you need for pre-clinical testing.
  • Design and manage your primary, secondary and safety pharmacology studies entrusting them to our cost-effective Quebec-based partners.
  • Generate your clinical supplies from Phase I to Phase III
  • Manage your regulatory submissions.
  • Manage your Phase I testing via our Quebec partners.

Tech Transfer : Mind the Gap.

Altus avoids Tech Transfer during time-critical product development by providing integrated Lab to Clinic to Market contract manufacturing. However, Altus will always ensure your product, the process, and the methods to test it, are in place, in time, wherever you want them.

Launch Supplies

Altus’s services include management of process scale up, method and process validation, and stability planning and execution. Cost-effective supply whenever you need it.

  Discover More About Formulation Development

FAQs about Launch & Commerical Supplies

The uncertainties of a global pharma supply chain
With an increasing number of pharmaceutical companies outsourcing manufacturing of their drugs to contract organizations (CMO) the supply chain for pharmaceutical products is becoming increasingly stretched, unstable, and uncertain. Examples of this uncertainty include quality issues with API manufacturers leading to drug shortages and quality issues with drug product suppliers leading product recalls and further shortages. Both put patients at risk.

Faultless supply chain planning using a trusted CMO is essential to get your product to the market and keep it there.

What are the requirements to transition from clinical to commercial?


If you don’t know where you are going, any road will take you there.

The Quality Target Product Profile or QTPP is a forward-looking summary of the quality and performance characteristics your product must have if it is to succeed on the market as a safe and effective drug. The QTPP provides the goals for product design and development. The QTPP describes the destination, the product development plan describes how you will get there.

When developing your QTPP you should consider:

  • The Intended use in a clinical indication, the route of administration, the dosage form, and any delivery challenges(s)
  • The intended dosage strength(s) for your product even if the
  • How you will package your drug i.e. the Container closure system
  • The drug release rates you need to achieve your dosing aims i.e. the drug delivery profile needed to meet the pharmacokinetic goals for your product. These include the dissolution profile for your drug or the aerodynamic performance needed to achieve your intended drug absorption site.
  • The drug product quality criteria appropriate for the intended marketed product (for example product sterility, product shelf-life, product purity and degradation profiles).

The QTPP is therefore an essential element of new drug planning and should include all the known performance and regulatory considerations needed for the product to perform as required in humans.

cGMP compliance

Growing from early stage trials, with only a few patients or subjects to large-scale Phase II and Phase III, while also remaining GMP compliant is a challenge and one that is often overlooked by rapidly growing pharmaceutical companies. Ignoring these considerations can cause costly delays .

It’s important when planning your clinical and commercial supply strategy to ensure all stages of development are throughout to so that product performance is maintained irrespective of the scale of manufacture. Building quality into your product early, also ensures that the regulatory requirements of FDA, EMA or other authorities are considered and that the data you need to meet their stringent requirements is available when you need it.

Safe Upscaling Capabilities

The transition from clinical trials manufacturing (CTM) to commercial manufacturing of a drug is complex and costly if not planned right. Having more product than you need is uneconomical, not having enough means reduced sales. Economic batch size calculations must be made early to avoid such issues while ensuring you have sufficient batch data to meet regulatory requirements regarding batch reproducibility (process robustness) and sufficient stability data to allow submission and launch. Process validation considerations and planned post approval changes must also be addressed e.g. SUPAC considerations;

There is also the possibility that your clinical manufacturer cannot accommodate the increased product volumes you need for product submission and launch meaning technology transfer , that is transfer of the manufacturing process for your product, and the analytical methods to monitor it, is required. Altus Drug Development ensures integrated product and manufacturing development, forward planning to avoid costly delays.

The Value of Integrated Analytical Development.

Analytical test methods must be developed to support the entire development process of a new drug and different methods are required for different phases. For example in early development, when little is known, multiple analytical tests might be used to characterize the drug substance (API) and drug product. Performing all these tests when releasing a product to market would be uneconomical. Altus Drug Development can help you transition from early to late stage development identifying the most cost-effective testing strategy to ensure product compliance and the specifications you need to justify process control

Altus Drug Development will first qualify and then validated these methods to meet international standards set by regulatory bodies such as ICH and FDA.

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