Dalton Announces the Launch of Steriles Made Simple(SM) Programs
Toronto, Ontario (PRWEB) December 02, 2014 -- Dalton Pharma Services announces the launch of its new Steriles Made Simple(SM) programs which are designed to produce clinical sterile liquid injectables faster.
Dalton’s objective for creating Steriles Made Simple(SM) was to use pre-prepared material, process and systems to deliver cGMP sterile liquid injectables to customers within 4 months of available API. This timeline targets simple liquid formulations for small molecule Phase I/II projects requiring batches of 10,000 vials or less. This program is scaled to the requirements of most early phase clinical studies and matches well with Dalton’s recently expanded sterile injectable manufacturing capacity.
Dalton has recognized its client’s need to get into the clinic as quickly as possible. This enables the company to get valuable clinical data that can lead to continued funding of their project or a higher product valuation. Sterile manufacturing can be more complex than other dosage forms, and requires the manufacturer meets increasingly strict regulatory requirements.
“We looked at the critical aspects of cGMP sterile vial manufacturing that resulted in the longest timelines and really simplified this complex process for our customers”, noted Peter Pekos, CEO & President of Dalton Pharma Services. “Steriles Made Simple(SM) has been a strategic priority for Dalton with a focus on delivering product faster, without compromising the quality.”
Dalton is accepting qualifying new projects for Steriles Made Simple(SM) with early 2015 start dates. Standard terms and conditions apply. Please contact Dalton Pharma Services for more information regarding its Steriles Made Simple(SM) programs or visit http://www.sterilesmadesimple.com.
About Dalton:
Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a Canadian cGMP contract pharmaceutical manufacturer that supplies chemistry, analytical and formulation development services to the biotechnology and pharmaceutical industries in the areas of chemistry, medicinal chemistry and fine chemical manufacture. Dalton provides cGMP manufacturing of solid dosage forms and aseptic filling services to its customers at any stage of the regulatory process (Phase I, II, III or commercial). In its modern cGMP facilities, Dalton produces active pharmaceutical ingredients at the gram or kilogram scale. Dalton conducts aseptic fills to produce batches of finished drug product in vials or syringes, either aseptically filled or terminally sterilized, under fully validated conditions. In addition, Dalton’s analytical chemistry laboratory offers method development, validation and ICH stability programs to its clients. http://www.dalton.com
For further information contact:
Peter Pekos
Dalton Pharma Services
416-661-2102
ppekos(at)dalton(dot)com
Peter Pekos, Dalton Pharma Services, http://www.dalton.com, 416-661-2102, [email protected]
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