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The classic pharmaceutical industry comprises small-molecule drugs, which are produced via chemical reactions and traditional chemical methods. Large-molecule drugs (biopharmaceuticals) are produced in biotechnological processes via genetically modified cells. Each presents distinct challenges in production techniques, modes of action and how they are formulated and administered.

IMPACT has a long history of helping both pharmaceutical and biopharmaceutical clients develop and optimize processes and equipment for both small and large molecule API production and drug delivery systems. Specialties include:

  • Development and manufacturing of single-use process equipment technologies,
  • Sustained release drug delivery technologies including microspheres.
  • Manufacturing process development including precipitation/crystallization, separations (centrifugation, filtration and process chromatography), and drying (conventional, spray, freeze)
  • Rheology/Rheometry

IMPACT specializes in the development, and design of single-use technologies for the biopharmaceutical industry. Skills include product design, prototype development, materials and adhesives selection, manufacturing process development and tool design, and assembly protocol development.

IMPACT has successfully developed and commercialized single-use technologies for both centrifugation and process chromatography for biopharm manufacturing.

IMPACT can help your company develop single-use technologies at our Development Center. To learn more about IMPACT’s experience with single-use product development, click here.

IMPACT has a core competency in the development and scale-up of microsphere-based technologies including sustained release drug delivery. These technologies include polymeric encapsulation, precipitation, and crystallization of APIs into uniform microspheres or crystals of controlled size and morphology (e.g.- insulin, hGH, mAbs, oligonucleotides). Processes developed have included both batch and continuous production and extend into downstream processes such as recovery, washing, buffer exchange, drying, and fill/finish. IMPACT’s expertise in microsphere production has also been utilized by Fortune 100 pharmaceutical companies to perform technical due diligence on microsphere technologies prior to acquisition.

IMPACT can help develop, scale-up, optimize, or troubleshoot your drug delivery manufacturing technology; from providing expert consulting services to developing a turn-key process solution at our Development Center. To learn more about IMPACT’s experience with sustained release drug delivery and microspheres, click here.

Precipitation or crystallization is often used in the pharmaceutical industry as a purification or separation technique, for intermediate stabilization for storage or shipping, or in producing a drug product form such as microspheres or crystals. The IMPACT team has an extensive knowledge base in both small- and large-molecule precipitation and crystallization for each of the purposes mentioned above.

IMPACT can help your company develop, scale-up, optimize, or troubleshoot both small- and large molecule precipitation and crystallization processes; from providing expert consulting services to developing a turn-key process solution at our Development Center.

To learn more about IMPACT’s experience with precipitation/crystallization, click here.

IMPACT has world-class expertise in bio-separations including process centrifugation, filtration, and process chromatography. The team collectively has:

  • Been employed at leading bio-separation companies such as Millipore, Sepracor, Becton Dickinson, CARR Separations, Kendro, Hemasure, Biosepra and Haemonetics,
  • Authored bio-separations articles in texts such as The Membrane Handbook,
  • Invented, developed and/or commercialized over 50 bio-separation technologies.

We can help you with solving difficult separation problems including technology assessment and selection, design and specification, application testing, and even development of a first-of-a-kind solution when none exists!

Lyophilization, or freeze drying, is a means of drying achieved by freezing a liquid/solid mixture and causing the frozen liquid to sublime by exposing it to a low partial pressure of vapor in a vacuum chamber. Biological materials often must be dried to stabilize them for storage or distribution. Conventional drying processes cause some loss of activity or other denaturation to biomolecules. Lyophilization is a method of drying that significantly reduces such damage.

IMPACT has a 4.2 ft2 freeze dryer located at its Development Center in Devens, MA. IMPACT uses the system to perform lyophilization cycle development, optimization studies, formulation screening, and small-scale manufacturing for pre-clinical studies. IMPACT engineers have significant experience with the design, operation, and process scale-up of lyophilization systems.

To learn more about lyophilization or IMPACT’s experience and capabilities with lyophilization, click here.

Spray drying is gaining more and more interest in the pharmaceutical industry as efforts to explore continuous processing continue to grow. Spray drying offers an efficient way to continuously dry both aqueous and solvent-based solutions and is also being used to form uniform particles when desired. The IMPACT team has expertise in spray drying process development and modeling. We have modeled particle formation during spray drying using computational fluid dynamics (CFD). IMPACT specializes in innovative uses of spray drying and would be happy to work with your company in developing spray drying processes.

  Rheology is a branch of physics that deals with deformation and flow of materials that are not well described by classical models of elasticity or fluid mechanics. It applies to substances which have a complex microstructure. Examples of such substances include: muds, slurries, suspensions, polymers, pharmaceutical formulations and additives, foods, and biological fluids and materials.

Rheometry is the experimental characterization of a material’s rheological behavior. IMPACT is knowledgeable of the connections between flow/deformation behavior of materials and their internal structure. We combine this theoretical knowledge with extensive experience in rheometry methods. We currently have a Haake controlled stress rheometer at our Development Center, which we have applied to measuring a wide range of materials and used the results to model their behavior.

To learn more about IMPACT’s experience or capabilities in rheology or rheometry, click here.