Millennium Research Laboratories - Polymer Science Manufacturing

Millennium Research Laboratories (MRL), was founded in 2002 by a founding group that possess decades of combined experience in the fields of polymer science, advanced materials, drug discovery, and development. MRL’s facility is located in Woburn, Massachusettes, US. It is designed for formulation work and small scale manufacturing, subdivided into three suites equipped with state-of-the-art instrumentation, and an office space.

MRL offers a wide spectrum of services and expertise in scientific, professional, technical, manufacturing, quality control, and regulatory fields. Our services include formulation development, drug delivery design, analytical methods development, validation and drug stability assessment, among other tasks.

Contract services

The one stop solution to all your analytical problems and more is our contract services:

• Methods development and validation
• Quality control testing
• Stability studies
• Characterization services (DS and DP)
• Performulation evaluations

Bioanalytical services

• Analytes: Biopolymers (oligos, peptides), small molecules, drugs, metabolites
• Matrices: plasma, serum, other fluids, and tissues
• Clinical trial samples analysis
• LC-MS, LC-MS / MS, CE, HPLC, peptide mapping

Stability studies

Stability studies (ICH, accelerated, long and short-term as well as photostability)include both standard and custom-order protocols:

• Long-term: 25° ± 2°C, 60% ± 5% RH for 3, 6, 9, 12, 18, 24, and 36 months
• Intermediate: 30° ± 2°C, 60% ± 5% RH / 65% ± 5% RH for 1, 2, 3, and 6 months
• Accelerated: 40° ± 2°C, 75% ± 5% RH for 1, 2, 3, and 6 months
• Accelerated: 50° ± 2°C, 75% ± 5% RH for 1, 2, 3 months
• Freeze-thaw (-20°C to ambient)
• Photostability

Formulation – pre-formulation to optimization

MRLs dosage form understanding of the cost pressures in today’s pharmaceutical environment ensure that we develop products that can be manufactured in a timely and reproducible manner using cost effective materials. Beginning with a concept, the experts at MRL can develop ideas into products.

MRL offers the following:

• Formulation development of both NDA and ANDA dosage forms
• Formulation troubleshooting and process development of existing dosage forms
• Optimization of existing formulations
• Quantitative and qualitative evaluation of proprietary dosage forms

In addition, MRL offers optimization of enhanced solubility, sustained delivery, controlled release, enhanced stability, targeted delivery, improved bioavailability, microencapsulation, acceptability for specialized use, and administration for alternate routes.

Extractable and leachable testing design

• Isolate, identify and quantify extractable
• Extractable profile characterization
• Elastomeric and rubber closure testing
• Trace level analysis