Our Development Process

Our Development Process & Approach

It is our mission to provide you with a product that has the highest level of sterility assurance and quality achievable. While we have invested in cutting-edge equipment and in our team, we also focus on our quality system and our approach to solving your complex problems. Our science is guided by the Quality by Design (QbD). This is a systematic approach to development, defined by ICH Q8 guidelines that “begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.”

Our Development Process:

 Before we start, we must define what we need to achieve:

  1. We first start by defining the desired product performance and identifying the Quality Target Product Profile (QTPP) of your drug product or medical device. The QTPP is the characteristics of your product that need to be achieved to ensure quality and efficacy.
  2. Next, we identify the Critical Quality Attributes (CQA). This is where we determine the appropriate limits, ranges, or distribution to evaluating if the product meets the QTPP.
  3. We also identify possible Critical Material Attributes (CMA) and Critical Process Parameters (CPP). These are material or process attributes whose variability can affect the CQA of the product. These attributes must be monitored and controlled to ensure proper drug product quality.

Once we have built our goal posts, we experiment to evaluate potential strategic approaches to achieving our target:

  • We setup and execute a Design of Experiments (DoE). This is where we plan, execute, analyze, and interpret controlled experiments and tests to reach our desired outcome: to link CMAs and CPPs to CQAs and determine these parameters impact on QTPP.

Once we have gathered sufficient evidence, we define a process to achieve QTPP:

  • We define a process design space to develop a product with the desired QTPP
  • We identify and control the sources of variability from the raw materials and the manufacturing process (CMAs and CPPs)

Now we have our process developed! After validation, we will continue to monitor and improve the process to assure consistent product quality.

Defining your product's Quality Target Product Profile (QTPP):

Your product’s Quality Target Product Profile (QTPP) informs us of what we need to achieve. This creates the basis for your drug product formulation and process development. To properly define your QTPP, we will review the following information with you:

      • The intended use of your product in its clinical setting
      • The route of administration
      • The dosage form
      • The delivery systems
      • The dosage strength(s)
      • The container closure system
      • The therapeutic moiety release or delivery process (if applicable) and attributes affecting pharmacokinetic characteristics appropriate to the drug product dosage from being developed
      • The desired quality criteria (e.g., sterility, purity, stability, and drug release)

For a sterile product, we must also examine:

      • Sterility
      • Endotoxin content
      • Container closure integrity
      • Container closure extractables and leachables
      • Anti-microbial preservative for a multi-dose presentation

QTPPs applicable to most parenteral products:

  • Dosage form
  • Route of administration
  • Strength
  • Dose
  • Indication
  • Dosing frequency
  • Label claim
  • Description of product
  • pH
  • Tonicity
  • Dose delivery
  • Fill volume
  • Particulate matter
  • Preservative content
  • Impurities
  • Sterility
  • Bacterial endotoxin
  • Container closure system
  • Shelf life

QTPPs of lyophilized products:

  • Uniformity of dosage
  • Properties of lyophilized cake
  • Process for reconstitution
  • Description of reconstituted solution
  • pH of reconstituted solution
  • Water content

Upcoming Webinar:

Wednesday, January 18 | 1PM EST

Why your container & closure choice matter in sterile fill finish