Contract Manufacturing and Continuous Flow Reactor Technology for Early-Stage Drug Development

Ash Stevens' James Hamby, Ph.D., Vice President of Business Development, reviews the applicability and advantages of continuous flow technology.

Pharmaceutical Company Announces $20M Expansion Project

Elected officials and SOCMA's President Larry Sloan toured the start of Ash Stevens' $20 million expansion project, which will nearly double employment and significantly increase manufacturing capacity.

Notes from the Floor at BIO 2010

Ash Stevens' multimillion dollar, multiyear expansion will add new capacity and capabilities, including new process-development laboratories, a high-potency drug development and manufacturing containment suite, a tate-of-the-art materials handling and storage facility, and a large-capacity reactor suite, among others.

SOCMA Member Ash Stevens Plans $20 Million Expansion

SOCMA reviews Ash Stevens' expansion project that will increase production by 50 to 80% and create 50 more full-time jobs.

High-Potency Expansion: Drug Compound Maker Expects Production Kick

President and CEO Stephen Munk explained how a $20 million expansion plan, which Michigan governments have supported with financial incentives, will significantly increase Ash Stevens' manufacturing capacity and employment.

Experimental Considerations in Headspace Gas Chromatography

In this peer-reviewed case study of amines, Hong Ming Chen, Quality Control Chemist at Ash Stevens and Laila Kott, Senior Scientist in Analytical Development, Small Molecules at Millennium Pharmaceuticals, discuss several parameters to be considered in developing a headspace GC method.

Bedrock Businesses of Southwest Michigan

Ash Stevens, founded in 1962, is named as one of the bedrock businesses of the region.

People and Companies Breaking New Ground

Ash Stevens was listed as one of several biotech companies restoring Detroit's entrepreneurial edge and culture of innovation. 

Only You Can Prevent Cross-Contamination 

Ash Stevens Vice President of Quality Assurance and Regulatory Affairs Gary A. Baker, Ph.D. outlines effective cleaning procedures for CMOs.

Trends in Innovator Contract Pharmaceutical Manufacturing 

Ash Stevens Vice President of Business Development, James Hamby, Ph.D., explains how the CMO business is being impacted by the rapidly changing global pharmaceutical market.

Cleaning & Validation

Ash Stevens Vice President of Quality Assurance and Regulatory Affairs Gary A. Baker, Ph.D. outlines the solid cleaning procedures and analytical verification techniques that customers should expect of contract manufacturers.

(Video) Fine Chemicals Producer Ash Stevens: Making Quality an Issue

Alex Scott discusses Ash Stevens 50% revenue lift in 2010, expansion plans, and Silver Awards from SOCMA.

Clean and Validated

Ash Stevens outlines the solid cleaning procedures and analytical verification techniques used to prevent cross-contamination.

MEGA Board OKs Credits for 8 Projects to Bring $80 Million in Investment

The Michigan Economic Growth Authority approved a $710,019 tax credit to support Ash Steven's $14.9 million expansion and renovation project in Michigan, which Ash Stevens expects will create 60 permanent jobs.

Podcast: Lucky and Good: Sourcing Success Is in the Details

Michigan API manufacturer Ash Stevens’ emphasis on clear communication and product quality has (along with good fortune) made it a home-grown success story with an international supplier and client base. Stephen Munk, President and CEO, shares secrets of sourcing success.

Roundup of Informex 2010

Pharmaceutical Technology profiles Ash Stevens recent honor from SOCMA for achievement in environmental, health, safety, and security (EHS&S) performance.

Foreign Outsourcing of Development has Pitfalls

Ash Stevens Vice President of Business Development James Hamby, Ph.D. and Vice President of Quality Assurance Gary Baker, Ph.D. examine common pitfalls encountered when outsourcing the development and manufacture of innovator APIs and the potential hidden benefits of outsourcing locally rather than offshore.

Informex: Mixed Outlook but Optimism Prevails

Alex Scott reviews Informex-attending companies, such as Ash Stevens, with growing revenues and factories.

Cover Story: Custom Chemicals

Ash Stevens President and CEO Stephen Munk, Ph.D. discusses multi-million dollar expansion plans and domestic outsourcing trends.

Quality by Design: Adding Another Dimension to Outsourcing

Ash Stevens Vice President of Quality Assurance and Regulatory Affairs Gary A. Baker, Ph.D. explains how Ash Stevens’ approach is aligned with Quality by Design principles. 

Pharmaceutical Makers Look For Ingredients Closer To Home

Ash Stevens President and CEO Stephen Munk, Ph.D. explains reasons why it may be best to manufacture their critical ingredients closer to home, at least in the early stages of drug development.

Pharmaceutical Technology Sourcing and Management

Exhibitors announce capacity expansions, service enhancements and new products at CPhI Worldwide.

Process Development and Scale-Up for APIs

sp² profiles Ash Stevens' $6 million dollar expansion and participation and certification in SOCMA's ChemStewards program.

Pharma Not Concerned Enough about Environment when Outsourcing; CEO

CPhI coverage: Ash Stevens discusses the long-term benefits of sourcing to U.S.-based companies.

Construction Starts on New Ash Stevens Expansion Project

CPhI coverage: Ash Stevens President and CEO Stephen Munk, Ph.D. comments on project to expand API manufacturing facility.

Fast Track to Market

"Time is of the essence in getting new drugs to market, and delays in scale-up or process development mean lost sales. So when a new drug was fast-tracked by the FDA, contract manufacturer Ash Stevens had to act equally fast."

Ash Stevens Starts $6M Expansion

Ash Stevens Vice President of Business Development James Hamby, Ph.D. describes expansion plans that will bolster CMC capabilities.

Anticancer Drugs: No Option But To Outsource?

Pressures in bringing anti-cancer drugs to market may require outsourcing to companies such as Ash Stevens, according to this article.

Stateside Surge In Pharma Chemicals

Ash Stevens has invested $18.5 million since 2000 on infrastructure improvements and plans to spend another $6 million on further improvements, including a new hydrogenation cell.

Staying On Track With Fast Track

Cutting average drug approval times from more than 18 months to less than a year, Fast Track can literally be a lifesaver for a patient with a life-threatening illness.

Low Temperature Chemistry: Keep Your Cool

Industry leaders, including Ash Stevens President and CEO Stephen Munk, Ph.D., discuss low temperature chemistry technologies.

Michigan Needs A United Voice For Biotech Industry Investment

Industry leader Ash Stevens comments on Michigan biotech.

Best Practices For Cancer APIs

Interview with Ash Stevens sheds light on API development processes and the new CMC alliance.

Largest Biotech Companies

Ash Stevens ranked as the 7th largest Detroit-area biotech company by Crain's.

An Unlikely Hot Spot

Ash Stevens supports local pharmaceutical companies to revitalize the life sciences industry in Kalamazoo.

Fine Chemicals Firms Continue To Expand

Post InformEx article in Chemical & Engineering News notes Ash Stevens as a company making expansions in 2009.

InformEx Report: Contract Manufacturers Expand

InformEx post show round up highlights Ash Stevens' investments in parallel synthesis and calorimetry instrumentation and certification in SCOMA's ChemStewards program.

Ash Stevens Enhances Speed And Safety Of Scale-Up With New Investments In Parallel Synthesis And Calorimetry Instrumentation

Ash Stevens discusses new investments in parallel synthesis and calorimetry instrumentation.

Fine Chemical Producers Strive to Meet Demand for High-Potency APIs

Ash Stevens President and CEO Stephen Munk, Ph.D., says ability "to deliver" is what differentiates high potency API manufacturers.

High-Potency API Expansion Plans Under Way As Market Soars

Ash Stevens shares its high potency expansion plans at CPhI.

Sourcing And Management Launches Community Of Experts Panel 

Dr. Stephen Munk, President and CEO of Ash Stevens, is announced as a member of the Community of Experts Panel for Pharmaceutical Technology’s Sourcing and Management newsletter. The community of experts will provide reviews of technical articles and offer perspectives on topics of relevance.

The Key to Success in High-Potency APIs

Dr. Stephen Munk, President and CEO of Ash Stevens describes keys to success in the high-potency API manufacturing process. Munk also addresses challenges in the Fast Track approval process and outsourcing opportunities for European companies with US-based contractors.

On the Fast Track: Project Management and FDA Interaction when an NDA is Fast Tracked

Gary Baker, Vice President of Quality Assurance and Regulatory Affairs, and Vince Ammoscato, Director of Project Management, both of Ash Stevens, detail how clients and their contractors can ensure smooth passage of a drug through the Fast Track program.

Contained Chemistry

This cover story explores how synthesizing highly potent compounds is a lucrative and growing niche for custom chemical manufacturers. As a notable developer of high potency anti-cancer compounds such as bortezomib, the API in Millennium Pharmaceuticals' multiple myeloma drug Velcade, Dr. Stephen Munk of Ash Stevens discusses containment strategies in general and the company’s approach.

32 Area Companies Among Small-Business Award Winners

Ash Stevens is named as one of the "50 Companies to Watch in Michigan".

Outsourcing Feature: CROs, CMOs Ride Outsourcing Growth

In this feature article on the growth of CROs and CMOs, Ash Stevens’ president and CEO Dr. Stephen Munk discusses the advantages of being a U.S.-based contract manufacturer.

Contract Research Services support API Manufacture 

President and CEO Dr. Stephen Munk describes Ash Steven’s evolution to a full-service contract manufacturer of APIs and its vision for the future in this in-depth feature.

Custom Synthesis of APIs

Ash Stevens CEO Dr. Stephen Munk describes the chemical approach Ash Stevens and Ilex Oncology (now part of Genyzme) took in successfully developing Clofarabine, the API in Clolar, an anticancer therapy.

Ash Stevens Plots a Steady Growth Path

This feature article explores how Ash Stevens is able to grow at a healthy rate and secure contracts in a highly competitive marketplace.

New Capabilities for Ash Stevens (Specialty Chemical News)

This feature article on developments at CPhI describes Ash Stevens’ new high containment capacity and low temperature pilot plant. Dr. Stephen Munk also explains the reasons behind the company’s success.