CMC Support Service

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CMC Support Service

The chemistry, manufacturing and controls (CMC) is a critical section of controlling the quality and safety of pharmaceutical products. CMC has gained a lot of importance to clinical trial or marketing application due to its essential role in ensuring the properties of product and manufacturing process to meet or excess the sufficiently high standards required by local or national regulators.

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CMC Support Service

Drug Substance and Drug Product Characterization

Physicochemical properties of drug substances or drug products, such as the solubility, dissolution rate and stability, play a significant role in the development of bio/pharmaceutical products. Undesirable features are closely related to most drug failure due to unfavorable pharmacokinetic toxicity and adverse side effects. Through well-designed protocols and extensive technology, our experts can conduct a variety of characterization studies, including:

  • pKa determination
  • ICH stability testing
  • Hygroscopicity
  • Log P/log D determination
  • Solubility analysis
  • Crystal form research
  • Other properties (particle size, shape, surface area, etc.)

Given the fact that majority compounds which can be used as drugs can exist in various solid forms (such as the salt, crystal or amorphous), different drug substances or the same molecules, therefore, are diverse in physicochemical properties, which might result in significant difference of pharmacokinetics and even bioactivity. In this case, choosing the most suitable solid form of active ingredients and excipients is critical to your overall development strategy.

The development of pharmaceutical products is characterized by lengthy and complexity that involves drug discovery, laboratory testing, animal studies, clinical trials and regulatory registration. To improve the effectiveness and safety of drugs, the FDA requires testing of drugs to ensure their properties, strength, quality, purity and stability before they can be used. Therefore, process control is essential to the quality control and is very important to all of pharmaceutical manufacturers. Generally, well-defined process controls mainly include the raw materials inspection, in-process controls and targets for final product.

In addition to the above, our customers can further be provided with:

  • Comprehensive proof of structure
  • Formulation support including excipient compatibility and micromeritics studies
  • Raw Material Sourcing
  • Preparation or optimization of advanced intermediates and APIs
  • Assist client to overcome any complex technical hurdles
  • CMC regulatory services for IND, NDA, and ANDA
  • CMC Guidance & Oversight
  • Quality audits for manufacturing and supply chains
  • Coordination of product manufacturing
  • One-stop services for method development and validation

BOC Sciences has a wealth of experience in dealing with all of regulatory aspects of CMC and offering the most suitable strategies to set specifications, method development and validation. Our team of experts not only focuses on chemically synthesized molecules, but also develops a variety of dosage forms. By working with our highly trained staff, you can get packaging services to support the entire development process from drug discovery to regulatory approval. In addition, BOC Sciences provides contract manufacturer identification, GMP auditing and extensive consulting services to our customers.

Reference

  1. Jatto, E., & Okhamafe, A. O. (2002). An Overview of Pharmaceutical Validation and Process Controls in Drug Development. Tropical Journal of Pharmaceutical Research1(2), 115-122.
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