SERVICES

LABORATORY TESTING, CONTROLLED SUBSTANCE MANAGEMENT AND LITERATURE SEARCHES

Most of our cases require preparation and testing of samples to determine whether a product or a material displays an attribute or infringes a patent claim. Available testing services include:

• Chain of custody procedures enabling fully documented tracking of materials as received and throughout processing.
• Preparation and testing of samples: ingredients, blends, and unit dosage forms including tablets, capsules, films, solutions, suspensions

Testing services are conducted using state of the art technology and industry-standard documentation protocols, including laboratory notebooks, electronic data generation, storage, and transfer, and technical reports designed to meet the client needs. Results are reported with maximum accuracy and integrity.

Our laboratories maintain Federal and NJ DEA licenses, enabling us to prepare and test samples containing controlled substances. We have developed ample expertise in procuring, handling and testing abuse deterrent attributes of opioid formulations.

We also provide a wide range of additional support services:

• Project management services, supporting multifunctional teams comprising client representatives, multiple expert witnesses, technical experts, laboratory personnel, and support personnel at Acumen.
• Materials management capabilities, including purchasing, transferring, and storing controlled substances, sample preservation, and materials disposal.
• Literature searches conducted by PhD scientists who can perform comprehensive and thorough searches in a minimum amount of time, providing clients with highlighted technical references and an analysis of their relationship to the case matter.

MANUFACTURING AND SAMPLE PREPARATION EQUIPMENT

• Powder feeding equipment
• Batch powder blenders and mixers, from 100 g to 100 Kg capacity
• Double cone blenders and mixers
• V-blenders and mixers (twin shell PK blenders)
• Bin blenders and mixers
• Ribbon blenders
• Acoustic RAM blenders and mixers
• Continuous powder blenders and mixers (5 Kg/h to 70 Kg/h capacity)
• Batch and continuous high shear granulators
• Batch and continuous fluid bed granulators
• Continuous twin screw granulators
• Batch and continuous fluid bed dryer
• Roller compactors
• Powder and granule mills
• Single punch tablet presses
• Compactor simulator
• Laboratory scale tablet presses
• Commercial scale tablet presses
• Single station capsule filling equipment
• Rotating ring capsule filling equipment
• Commercial scale intermittent capsule filling equipment
• Batch tablet and capsule coating equipment
• Batch and continuous film casting equipment
• Liquid mixing/suspension preparation equipment
• High shear/high pressure homogenization equipment
• Hot melt extrusion equipment

TRADITIONAL TESTS

• Blend sampling
• Blend homogeneity (NIR spectroscopy, Raman spectroscopy, HPLC)
• Content uniformity (NIR spectroscopy, Raman spectroscopy, HPLC)
• Tablet and capsule dissolution (USP; HPLC & UV)
• Hardness testing (USP/EP, Instron)
• Friability testing (USP)
• Viscosity testing (Brookfield, TA, Malvern)
• Particle size analysis
• Laser-light scattering
• Image analysis
• Sieve analysis
• Blend density (bulk and tap density, Carr index, Hausner ratio)
• Angle of repose
• Chemical testing

SPECIALTY TESTS

• Biorelevant dissolution (TIM system)
• Powder shear sensitivity
• Powder electrostatics
• Powder hydrophobicity and wettability
• Powder cohesion and flow properties
• Powder segregation
• Powder electrostatics
• Liquid homogeneity (Laser Induced Fluorescence)
• Tablet indentation
• Micro-hardness and nano-hardness indentation testing
• Tablet hydration
• Tablet microstructure
• Micro and nano imaging tools
• Scanning Electron Microscopy (SEM)/ with Energy Dispersive X-ray Spectroscopy (EDX/EDS)
• Transmission Electron Microscopy (TEM)
• Atomic force microscopy (AFM)
• Raman spectroscopy
• 3D Raman Chemical Imaging
• NIR Chemical Imaging
• X-ray computer Tomography (X-ray CT)
• Ultrasound analysis
• Optical microscopy / image analysis

PRODUCTS

• Direct compression tablets
• Wet granulated tablets
• Dry granulated tablets
• Hot melt extruded tablets
• Capsules
• Films
• Suspensions
• Solutions
• Emulsions
• Ointments
• Ophthalmic formulations
• Injectable Formulations
• Immediate release products
• Modified release products
• Sustained release products
• Delayed release (enteric) products
• Tamper resistant products

ANTITRUST LITIGATION

Antitrust laws also referred as “competition laws” are intended to ensure that there is fair competition in an open-market economy to protect consumers. This is not protection from competition, but instead through competition, the antitrust laws serve as a core component of U.S. economic policy. Intellectual Property litigations between the Innovator product (branded) company and generic manufacturers with PIV filings may end in settlements between the players that may potentially infringe antitrust laws. Some types of pharmaceuticals antitrust cases:

• Reverse payment or pay-for-delay
• “Product hopping” through the introduction of new versions of brand name products facing generic competition
• Drug product price fixing practices

Our industry expert consultants have extensive experience in pharmaceutical product Life Cycle Management including pre- and post-Loss of Exclusivity (LOE) strategies, as well as commercialization of Paragraph IV ANDA, 505 B2, authorized generics submissions and approvals. Our experts have been closely involved in the planning and execution of generic and branded product launches including:

• Regulatory compliance
• Manufacturing site readiness strategies
• Inventory management
• Product pricing strategies
• Market access strategies
• Distribution channels
• Direct/indirect payor strategies

Our hands-on consultants provide impartial and thorough analysis of data to support clients in the assessment of the industry practices and procedures applied by the parties of the antitrust litigation. All service follows Acumen principles and values that are built on the highest level of integrity and objectivity.

PROCESS TROUBLESHOOTING, QUALITY COMPLIANCE AND TECHNICAL TRAINING (FOR PHARMACEUTICAL SCIENTISTS)

Our extensive experience in pharmaceutical product and process development and regulatory compliance is also extensively utilized by pharmaceutical companies to address a number of needs:

• Conceptual design of pharmaceutical products and manufacturing processes
• Process troubleshooting: overcoming product failures, identification of failure causes, designing product testing plans, and supporting companies in their efforts to achieve and maintain quality compliance
• Technical training: formulation methodologies, manufacturing methods, implementation of continuous manufacturing systems, characterization of material properties, QbD, PAT, and statistical methodologies

Our experts have pioneered the use of process modeling methods that are becoming increasingly useful in product and process development and regulatory filings:

• Discrete element modeling of powder processes
• Computational fluid mechanics modeling of liquids, gases, and suspensions
• Population balance models of granulation, drying, milling, and blending processes
• Statistical modeling methodologies including DOE, RSM, PCA, PLS, and many others
• Residence time distribution and flowsheet process models for continuous manufacturing systems

IP STRATEGY

Our services in this area focus on proactive management of IP issues. We help innovators to identify opportunities for developing IP. This includes analyses of the patent landscape, identification of opportunities for innovative development, help in articulating inventive concepts, and critical analysis of patent language to identify and mitigate weaknesses, resulting in stronger patents.

We also help clients determine whether they are infringing a patent (or whether a competitor is infringing their patent) by performing a technical analysis of the accused product, method, or process relative to the relevant patents.

Also, we advise clients that seek to minimize the probability of infringing an existing patent. This includes an analysis of the scope of existing patents, and identification of product design methodologies that reduce the probability of infringement (whether literally, or under doctrine of equivalents).