CONTRACT RESEARCH

CONTRACT RESEARCH
CONTRACT RESEARCH

Drug Discovery and Drug Development Services

Drug Discovery and Drug Development Services

Drug Discovery and Drug Development Services

Our integrated Drug Development Services are designed to reduce your costs and timelines, helping you meet your drug discovery milestones.  Our innovative senior chemists have accumulated over 200 years of chemistry experience.  This enables us to efficiently create molecules to your specifications in our fully equipped Custom Synthesis laboratories.  In addition, our process chemistry experts can optimize your process and scale-up in accordance with your requirements for API manufacturing.

Our drug development services are supported by integrated Analytical Services, cGMP API Synthesis, preparation of standards and automated purification by HPLC or low pressure chromatography.

Our mission is to be a responsible and reliable drug discovery contract research partner throughout your project.  We can accelerate your drug discovery and development program by integrating process development, API manufacturing, and finished dose manufacturing all at a single location.

Our integrated Drug Development Services are designed to reduce your costs and timelines, helping you meet your drug discovery milestones.  Our innovative senior chemists have accumulated over 200 years of chemistry experience.  This enables us to efficiently create molecules to your specifications in our fully equipped Custom Synthesis laboratories.  In addition, our process chemistry experts can optimize your process and scale-up in accordance with your requirements for API manufacturing.

Our drug development services are supported by integrated Analytical Services, cGMP API Synthesis, preparation of standards and automated purification by HPLC or low pressure chromatography.

Our mission is to be a responsible and reliable drug discovery contract research partner throughout your project.  We can accelerate your drug discovery and development program by integrating process development, API manufacturing, and finished dose manufacturing all at a single location.

Stegram Pharmaceuticals Contract Research and Drug Development Services include:

  • Synthetic feasibility
  • Scale up
  • Process development
  • Lead optimization
  • Drug analog synthesis
  • Structure activity optimization
  • Route development
  • Medicinal Chemistry research

If what you are looking for is not on the list please contact us at +44(0)8712455161 or email us. Our Contract Research and Drug Development Services department will gladly meet your Drug Discovery needs.  

 

Medicinal Chemistry, Drug Discovery and Development Services

Medicinal Chemistry, Drug Discovery and Development Services

Medicinal Chemistry, Drug Discovery and Development Services

Stegram Pharmaceuticals Medicial Chemistry was built on 30 years of strength and excellence at Dalton Pharma Services. Stegram Pharmaceuticals Medicinal Chemistry is a highly focused team of committed, knowledgeable medicinal chemists with expertise in small molecule drug discovery and development.

Stegram Pharmaceuticals Medicinal Chemistry augments your in-house expertise and capabilities, serving as an extension of your own R&D group and as a responsive and reliable partner. We work closely with our partners to design and synthesize compounds for their targets and assays, leading ultimately to the identification of development candidates.

Our track record of identifying novel chemical entities for your Discovery/Development pipelines has been demonstrated to date through three publicly announced partnerships with Biotech (BioRelix & Bikam) and Pharma (Boehringer Ingelheim).

Stegram Pharmaceuticals Medicial Chemistry was built on 30 years of strength and excellence at Dalton Pharma Services. Stegram Pharmaceuticals  Medicinal Chemistry is a highly focused team of committed, knowledgeable medicinal chemists with expertise in small molecule drug discovery and development.

Stegram Pharmaceuticals Medicinal Chemistry augments your in-house expertise and capabilities, serving as an extension of your own R&D group and as a responsive and reliable partner. We work closely with our partners to design and synthesize compounds for their targets and assays, leading ultimately to the identification of development candidates.

Our track record of identifying novel chemical entities for your Discovery/Development pipelines has been demonstrated to date through three publicly announced partnerships with Biotech (BioRelix & Bikam) and Pharma (Boehringer Ingelheim).

Stegram Pharma Medicinal Chemistry Focus

  • Quality and creativity
  • Commitment to achieving our customer’s goals
  • Timely, clear, detailed communication
  • Sensitivity to timelines
  • Adaptable to accommodate changing priorities

Stegram Pharma Medicinal Chemistry Expertise

  • Structure- and ligand-based analog design
  • Synthetic organic chemistry of all major chemotypes; focused library synthesis
  • Rapid, efficient execution of iterative design, synthesis and SAR elucidation
  • Experience in Drug Discovery of major target classes
  • Problem solving – synthetic Discovery, SAR analysis, ADMET issues

Stegram Pharma Medicinal Chemistry offers significant experience in Fragment-to-Lead, Hit-to-Lead, and Lead Optimization capabilities in advancing compounds to development against a wide variety of target types and therapeutic areas.

Selected Areas of Previous Experience

  • Antibacterials
  • Antivirals
  • Diabetes/obesity
  • Cancer/oncology
  • Neuropathic pain
  • Inflammation
  • Multiple Sclerosis
  • Alzheimer’s
  • Cardiovascular agents
  • Anti-aging

Stegram Pharma Medicinal Chemistry Focus

  • Quality and creativity
  • Commitment to achieving our customer’s goals
  • Timely, clear, detailed communication
  • Sensitivity to timelines
  • Adaptable to accommodate changing priorities

Stegram Pharma Medicinal Chemistry Expertise

  • Structure- and ligand-based analog design
  • Synthetic organic chemistry of all major chemotypes; focused library synthesis
  • Rapid, efficient execution of iterative design, synthesis and SAR elucidation
  • Experience in Drug Discovery of major target classes
  • Problem solving – synthetic Discovery, SAR analysis, ADMET issues

Stegram Pharma Medicinal Chemistry offers significant experience in Fragment-to-Lead, Hit-to-Lead, and Lead Optimization capabilities in advancing compounds to development against a wide variety of target types and therapeutic areas.

Selected Areas of Previous Experience

  • Antibacterials
  • Antivirals
  • Diabetes/obesity
  • Cancer/oncology
  • Neuropathic pain
  • Inflammation
  • Multiple Sclerosis
  • Alzheimer’s
  • Cardiovascular agents
  • Anti-aging

Polymorphic Screening

Polymorphic Screening

Polymorphic Screening

Polymorphism is the ability for a single chemical entity to form two or more crystalline phases. Having a clear understanding of the polymorphism of your product is central to gaining US FDA approval of your NDA. It is critical that an optimum solid form is chosen for manufacture since the polymorphic form can severely impact physical characteristics resulting in lower Bioavailability.

Stegram Pharmaceuticals can perform screening of polymorphic forms for any API of interest via state of the art analysis including DSC, XRPD, FTIR and dissolution/solubility testing to determine the best polymorphic form for your product. Stegram Pharmaceuticals can also identify additional polymorphs for IP protection purposes, supporting your filing.

Polymorphism is the ability for a single chemical entity to form two or more crystalline phases. Having a clear understanding of the polymorphism of your product is central to gaining US FDA approval of your NDA. It is critical that an optimum solid form is chosen for manufacture since the polymorphic form can severely impact physical characteristics resulting in lower Bioavailability.

Stegram Pharmaceuticals can perform screening of polymorphic forms for any API of interest via state of the art analysis including DSC, XRPD, FTIR and dissolution/solubility testing to determine the best polymorphic form for your product. Stegram Pharmaceuticals can also identify additional polymorphs for IP protection purposes, supporting your filing.

Many APIs exhibit several polymorphic forms and in many cases there is only one desired polymorph.

Performing Polymorphic Screening is critical because:

i) Polymorphs have different physico-chemical properties such as solubility, dissolution rate and melting point which influence their biological activity, pharmaco-dynamic properties and stability. Therefore, polymorphic forms of an API are considered to be different chemical entities by drug regulators.

ii) Your product may not be thermodynamically stable in its current polymorphic form and during formulation of the drug product or during storage it may transform to another polymorph, which could lead to rejection of the API or dosage form product.

iii) Polymorphic forms are subject to IP protection. Innovator companies identify polymorphs in the active pharmaceutical ingredient (API) to protect the associate IP related to a new API and thus avoid premature competition from generic companies.

iv) Generic companies try to identify usable polymorphic forms of drugs that are not restricted by innovator patents, so that they can launch a non-infringing generic version of the product.

Amorphous Screens

In many cases crystalline polymorphs do not allow for sufficient aqueous solubility and the amorphous form may be required. Stegram Pharmaceuticals has in-depth experience in the numerous techniques used to induce the amorphous forms of active pharmaceutical ingredient.

Stegram Pharmaceuticals has the in-depth knowledge and experience to perform exhaustive polymorphic screening for you. A typical screen will consist of the analysis of different forms induced by solvent type, slow and fast evaporation, slow and fast crystallization, thermal, and physical (grinding). XRPD will typically be applied to initially study of the polymorphic form followed by DSC, FTIR, Melting Point, normal and accelerated stability, dissolution and solubility studies to provide you with all the necessary data so you can make an informed decision as to which polymorph you desire for your API drug substance.

Project Management

Project Management

Project Management

We understand the critical importance of project management in ensuring the success of the drug development programs of our clients.

A dedicated Project Management Team is charged with the responsibility of keeping a project on time and on budget by proactively identifying and resolving any potential issues before problems arise. Each project is overseen by a Project Manager experienced in GMP operations. Before a proposal is presented to a client, every project undergoes rigorous review in order to assess feasibility and ensure alignment of the client’s expectations with our technical capabilities. This is part of Stegram Pharmaceuticals commitment to quality.

The project manager assigned to your project:

  • Works with you to build a detailed project plan that meets your deliverables.
  • Reviews the scope and makes any necessary adjustments to mitigate risk throughout the duration of the project.
  • Actively monitors the project and keeps you informed with timely updates and regular meetings.
  • Drives project execution to ensure your project stays on schedule and on budget.

Project management is a core skill at Stegram Pharmaceuticals. We are dedicated to the use and development of best practices in this critical area to advance your drug development project.

“Our CMO 2020 and 2017 Leadership Awards in the categories of Quality, Reliability, Capabilities, Expertise, Compatibility and Development from Life Science Leader affirms our excellence in customer service”.

Integrated Drug Discovery, Development and Manufacturing

copyright© 2022 stegrampharma.co.uk