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May 9, 2023

Integrating Solid-State Chemistry into API Process Development

You may have heard from many solid-state chemistry experts state that selecting the right solid-state form saves you money. However, have you considered what that statement means and the impact selecting the correct solid-state form has on your program? It means understanding your API and if it exhibits polymorphism and […]
June 17, 2022
When Should I Hire a CMC Consultant?

When Should I Hire a CMC Consultant?

Deciding when to hire a Chemistry, Manufacturing, and Controls (CMC) expert can be difficult. On the one hand, a CMC consultant can supervise your project from start to finish and provide valuable knowledge throughout the process. On the other hand, Biotech startups need to work within constraints. One common option […]
February 24, 2022

Tour the Regis Facility and Learn About Our Capabilities For Custom Pharmaceutical Development and Manufacturing

The History and Development of Regis Technologies Over the past 65 years, Regis has continuously invested in better serving our life science customers.  Below are key dates in our history that document not only our organization’s evolution, but our ever-growing capabilities: Development, Production, and Finishing at the Regis Facility The […]
November 9, 2021
Solid State Chemistry

Solid State Chemistry During the Early Stages of Pharmaceutical Development

Phase 1 to Phase 2:  What Should Be Done during the Early Stages of Drug Development? Submitting the appropriate information for an IND application, especially the solid state aspects of the drug substance (DS), can accelerate new drugs into clinical trials.  Having the appropriate information from a physicochemical perspective will […]
July 1, 2021

Analytical Method Development: Best Practices for Successful Filings – and Beyond

Delay Method Development at Your Own Peril! Small and virtual pharma companies mindful of constrained budgets often defer analytical method development until later stages. But delaying analytical process development from pre-clinical to IND or NDA stages bears its own costs…and they can be exorbitant. Need to Develop Analytical Methods? Start […]
May 30, 2021
Specification setting is – in some measure – an art. While regulatory guidelines delineate what specifications should entail to ensure patient safety (e.g., ICH Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances), applying specifications throughout pharmaceutical development requires interpretation and judgement applied by various scientific subject matter experts.

Specification Setting During Chemical API Development

Over the last twenty years or so, the paradigm behind setting specifications has undergone something of a transformation. Much can be attributed to the adoption of risk-based methodologies, such as Quality by Design (QbD), advancements in technology, and harmonization of world regulatory expectations. The Art of Medicinal Science Specification setting […]
May 2, 2021
One of the most important elements of successful drug substance project onboarding is project management.

What You Need to Know About Contract Pharma Project Onboarding and Kickoff

Successful pharmaceutical project onboarding – whether at a CRO, CMO or CDMO – hinges on three key factors: Flexibility Communication Relationships. All of these factors depend heavily on the project team. Select the Right Project Manager One of the most important elements of successful drug substance project onboarding is project […]
March 14, 2021
Impurity control is a critical aspect of any pharmaceutical development process, but regulatory guidance tends to be vague where limited use during clinical trials is concerned.

Managing Impurities During Clinical Trials

Impurity control is a critical aspect of any pharmaceutical development process, but regulatory guidance tends to be vague where limited use during clinical trials is concerned. According to AstraZeneca’s Andrew Teasdale: “Permissible limits for impurities during clinical development has always been a grey area. Existing guidelines, specifically ICH Q3A, only […]
February 23, 2021

Top 4 Criteria for Choosing the Right CDMO for an Orphan Drug

In the United States, a rare disease is defined as one that affects less than 200,000 patients. Today there are approximately 7,000 known rare diseases affecting more than 30 million Americans. Between 1973 and 1983, there were fewer than ten drugs on the market that treated rare diseases. In 1983 […]
February 7, 2021
Intermediate; isolated to confirm polymorph and crystalline habit (particle shape). Regis Technologies , Inc.

Solutions to Common Small Molecule Drug API Manufacturing Challenges: Solid Form Isolation

Contract Development and Manufacturing Organizations (CDMOs) evaluate and transfer many small molecule active pharmaceutical ingredient (API) processes. In our experience, the chemistry that is presented in the technical packets frequently represents a medicinal chemistry process or a cursory attempt at a scalable route. Therefore, the API often requires significant further […]
January 16, 2021
A heat/energy map of the wet milling action zone of the HV, showing the concentrated points of energy dissipation.

The Advantages of Wet Mill Micronization in Pharmaceutical Manufacturing

Particle size reduction techniques such as micronization are an essential aspect of pharmaceutical manufacturing operations – and their importance continues to grow. Micronization and other particle reduction techniques are a mainstay in addressing poor drug solubility. Once an exception rather than a rule, most new drug compounds today are highly […]
November 19, 2020

How to Identify and Control Drug Impurities Quickly with a Holistic Approach

Impurity isolation and identification in active pharmaceutical ingredients (APIs) and pharmaceutical drug products (DPs) is a critical aspect of the development process. The need to meet the quality guidelines outlined by the ICH (International Conference on Harmonisation) and adopted by regulatory agencies worldwide would be the most obvious reason. But […]
October 16, 2020
Picking and choosing CROs and CDMOs based solely on cost can ultimately raise project costs and slow your drug development and commercialization.

Are Offshore CROs the Best Choice for Initial Drug API Quantities?

Picking and choosing CROs and CDMOs based solely on cost can ultimately raise project costs and slow your drug development and commercialization. Several weeks ago, we were approached by a company seeking an initial preparation of 20-25 grams of an API. They were a small pharma firm, with a limited […]
October 1, 2020
Building Solid State Knowledge for Regulatory Authorities

Why You Should Leverage Pharmaceutical Solid State Chemistry Early in Drug Development

Pharmaceutical solid state chemistry – the study of functional relationships between the synthesis, structure, and properties of solid phase materials – plays a crucial role in successful drug development and commercialization. As active pharmaceutical ingredients (APIs) have grown more complex, the importance of understanding the polymorphic landscapes have, as well. […]
October 1, 2020
Welcome to the Regis Technologies Blog, where we’ll be sharing news and information about our custom pharma contract development and manufacturing services as well as our portfolio of chromatography columns and specialty reagents.

Welcome to the Regis Technologies Blog

Welcome to the Regis Technologies blog, where we’ll be sharing news and information about our custom pharma contract development and manufacturing services as well as our portfolio of chromatography columns and specialty reagents. Regis Technologies, Inc. partners with pharmaceutical and biotechnology companies to help expedite their drug candidates to market. […]