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pharmaceutical manufacturing

ICP-OES Equipment Adds New Testing Capabilities to Laboratory At Houston Pharmaceutical Contract Manufacturer

Houston, TX (April 25, 2019) – Pharmaceutical contract manufacturer WDPrx – Woodfield Pharmaceutical, LLC installed new ICP-OES equipment to expand testing services to include impurities in raw materials that may affect product quality and patient safety. Pharmaceutical manufacturing is complex.  Challenges arise during each phase of Development, Validation, Analytical Testing, Quality Assurance, Quality Control, Manufacturing, Packaging, Labeling and Regulatory Compliance. Unique obsta...

Homogenization Is Key To Semi-Solid Pharmaceutical Manufacturing

Producing quality semi-solids literally boils down to five key physical characteristics: homogeneity, particle distribution, spreadability, grittiness and use of surfactants. If one element fails, then the entire process breaks down. Each element must be closely monitored from beginning to end and after sale to assure patients receive the correct medication in the specified concentration throughout the life of the product. Pharmaceutical manufacturing of quality semi-solid products involves spec...

The Cost and Expense of Technology Transfer

Although they appear as synonyms in the thesaurus, the words ‘cost’ and ‘expense’ have two different meanings when referring to technology transfer in pharmaceutical contract manufacturing. A technology transfer is the process of changing manufacturers of a pharmaceutical drug product.  The pharmaceutical outsourcing procedure involves thorough analysis of every phase of the current manufacturing process from raw materials sourcing and process requirements to equipment s...

Six Steps Pharmaceutical Manufacturers Should Follow For Successful CMO Projects

The relationship between pharmaceutical manufacturers and their contract manufacturing organizations is a key factor determining successful outcomes. Several important areas should be considered during project negotiations between manufacturers and their CMO partners to maintain productive relationships that maximize positive results.  These categories include dispute resolution, division of responsibilities, changes requested outside the agreement terms, regulatory compliance filing requi...

Rising CMO Business Fortunes, by Adam Runsdorf

The current business climate favors forward-thinking contract manufacturing organizations that improve ties with manufacturers for services across the entire value chain, writes WDPrx President Adam Runsdorf in the May 2018 issue of Contract Pharma magazine. Read the article on the Contract Pharma site. The relationship of pharmaceutical manufacturers with contract manufacturing organizations (CMO) and contract development and manufacturing organizations (CDMO) is increasingly evolving from one-...

Quality Factors Influencing Semi-Solid Manufacturing

This story appears in the January 2018 issue of Contract Pharma magazine. Read it here. QUALITY FACTORS INFLUENCING SEMI-SOLID MANUFACTURING Kalpen Patel, Research and Development Manager, WDPrx Angela Holley, Business Development Director, WDPrx Although the name suggests otherwise, manufacturing semi-solid pharmaceutical drug products cannot be done ‘half-way.’  The making of semi-solid dosage forms, including pastes, ointments, gels and creams, requires specialized production techniques ...

The Single Skill That Makes Or Breaks Technology Transfer Projects For Contract Manufacturers

Relationships are difficult to navigate effectively.  One party often feels the other is taking advantage of the situation.  Things are left unsaid.  Things that are said are often not meant.  Disagreements may occur. Such is the world of technology transfer for pharmaceutical contract manufacturers. Encourage Communication Technology transfer involves the efficient transition of technical and manufacturing capabilities between separate entities.  Developing and manufacturing pharmaceutical...

Contract Packaging Operations At The Center Of Transition To Serialization

A version of this story appeared in the June 2017 issue of Contract Pharma Magazine under the title “Adapt Or Die.” Adapt Or Die As companies within the pharmaceutical supply chain near the November 27, 2017 deadline for the most recent phase of DSCSA compliance, contract packaging operations with comprehensive serialization implementation programs will see their business increase due to the new requirements. A primary goal of the DSCSA is improving information transparency to minimi...